Intervention Review

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Non-specialist health worker interventions for the care of mental, neurological and substance-abuse disorders in low- and middle-income countries

  1. Nadja van Ginneken1,2,*,
  2. Prathap Tharyan3,
  3. Simon Lewin4,5,
  4. Girish N Rao6,
  5. SM Meera2,
  6. Jessica Pian7,
  7. Sudha Chandrashekar7,8,
  8. Vikram Patel1,2

Editorial Group: Cochrane Effective Practice and Organisation of Care Group

Published Online: 19 NOV 2013

Assessed as up-to-date: 2 OCT 2012

DOI: 10.1002/14651858.CD009149.pub2


How to Cite

van Ginneken N, Tharyan P, Lewin S, Rao GN, Meera SM, Pian J, Chandrashekar S, Patel V. Non-specialist health worker interventions for the care of mental, neurological and substance-abuse disorders in low- and middle-income countries. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD009149. DOI: 10.1002/14651858.CD009149.pub2.

Author Information

  1. 1

    London School of Hygiene & Tropical Medicine, Centre for Global Mental Health, London, UK

  2. 2

    Sangath, Goa, India

  3. 3

    Christian Medical College, South Asian Cochrane Network & Centre, Prof. BV Moses & ICMR Advanced Centre for Research & Training in Evidence Informed Health Care, Vellore, Tamil Nadu, India

  4. 4

    Norwegian Knowledge Centre for the Health Services, Global Health Unit, Oslo, Norway

  5. 5

    Medical Research Council of South Africa, Health Systems Research Unit, Tygerberg, South Africa

  6. 6

    National Institute of Mental Health and Neuro Sciences, Department of Epidemiology, Bangalore, Karnataka, India

  7. 7

    London School of Hygiene & Tropical Medicine, London, UK

  8. 8

    St. Johns Research Institute, Bangalore, India

*Nadja van Ginneken, Centre for Global Mental Health, London School of Hygiene & Tropical Medicine, Keppel St, London, WC1E 7HT, UK. nadja.vanginneken@lshtm.ac.uk. nvanginneken@yahoo.co.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 19 NOV 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Ali 2003 RCT Pakistan

MethodsStudy design: RCT

Duration of study: Baseline survey January to April 2001 and considering the 8-week intervention must be between May to June-July 2001


ParticipantsCountry: Pakistan

Income classification: Low income

Geographical scope: Semi-urban: in Qayoomabad, lower middle class semi-urban community with a population of 80,000 in Karachi

Healthcare setting: Home

Mental health condition: Common mental disorders

Population: Adults

  • Age: 18-50 years
  • Gender: Female
  • Socioeconomic background: Lower-middle class. Women predominantly aged 26-40 years, half had no formal education, not involved in revenue generation, two-thirds had a household income of > 3000 PKR, nearly 60% were residing for more than 10 years
  • Inclusion criteria: Participant: women 18-50 years old; able to communicate in Urdu, planning to live in the study area for more than 1 year, no bereavement in past 6 weeks


  • Exclusion criteria: Participant women: those actively suicidal


InterventionsStated purpose: To assess the effect of on levels of anxiety or depression (or both), among women who had attended counselling sessions, provided by briefly trained counsellors of their own community

INTERVENTION:

Name: Counselling

Delivered by:

  • Title/name of NSHW/OPHR and number: 21 minimally trained counsellors
  • Selection: "Women were informed by word of mouth and by leaflets; out of 73 women who came for interview, 21 selected based on communications skills, motivation, attitude, ability to read and write Urdu and freedom to move in the community"
  • Educational background: "Ability to read and write Urdu" and belonging to local community
  • Training: 11 training sessions held over 4 weeks. Each lesson lasted 3 hours and was led by either a family practitioner, a sociologist, a psychiatrist or 3 clinical psychologists. Contents: Basic information regarding anxiety, depression, stress/anger management, and communication/counselling skills. Communication covered active listening, probing and feedback, whereas counselling dealt with supportive problem-solving and cognitive-behavioural techniques. "Manual incorporating the training material is being published and is planned to train master training who could replicate the study in several urban and rural centers"
  • Supervision: "Women had ready access to members of the training team throughout the study period"
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: 8 sessions (?possibly weekly). Supportive, cognitive and problem-solving counselling was provided on the day and time convenient of the woman
  • Content of intervention: The trained counsellors provided supportive, cognitive and problem solving counselling at the clients residence at convenient time


CONTROL: Usual care, no intervention, just had AKUADS administered at baseline and end of study; however, "as the effectiveness of counselling was proved, for ethical reasons the control group was also counselled" possibly at the end of the study

CO-INTERVENTIONS: Nil


OutcomesPatient: Reduction in Aga Khan University Anxiety and Depression Scale scores

Carer: Not applicable

Process/health worker outcomes: Not specified

Economic outcomes: None

Time points: Baseline and at the end of 8 weeks


NotesSource of funding: Academic body; Aga Khan University Research Council

Notes on validation of instruments (screening and outcomes): AKUADS (indigenous screening scale, developed from complaints of patients with anxiety/depression, recorded verbatim in Urdu) previously validated against psychiatrist evaluation as gold standard and compared with SRQ

Additional information: None

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Not specified


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Every third household was systematically sampled in all of Qayoomabad. [...] One woman was randomly chosen from each selected household and screened for anxiety and/or depression. [...] Using computer-generated random numbers, 216 [of 1218 women] cases were randomised to the intervention and 150 to the control group". The initial selection was quasi-random, but then allocation to control or intervention was random 

Allocation concealment (selection bias)Unclear riskQuote: "Computer-generated random numbers"

Comment: Even though sequence generation was centrally done, it was unclear how allocation was concealed

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Not able to blind participants or personnel. Unlikely to influence outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No selective reporting. Not applicable

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskComment: Independent data collectors blind to allocation and to the previous scores

Baseline outcome measurements similarLow riskComment: Yes similar, both across intervention and control, and between dropouts and non-dropouts

Baseline characteristics similar?Low riskComment: Yes, similar. All P values over 0.2 comparing dropouts versus non-dropouts and intervention versus control groups

Incomplete outcome data (attrition bias)
Efficacy data
High riskComment: Intervention: 68% dropout between baseline and those completing the intervention. Control: 33% dropout. Though characteristics are similar between dropouts and non-dropouts (including baseline scores), their scores may have been different at follow-up

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No reported safety outcomes

Protection against contaminationLow riskQuote: "The spontaneous decrease in the score [in the control group] could be attributed to the natural history of depression, which waxes and wanes, but a contaminant effect of counselling cannot be ruled out" " the effect of summer holidays occurring during the study period was also considered as possibly "causing contamination"

Reliable primary outcome measuresLow riskComment: AKUADS administered by trained people not delivering intervention. So unlikely to be bias

Selective reporting (reporting bias)Unclear riskComment: No selective reporting. but no protocol to assess if this is the case

Other biasLow riskComment: None detected

Araya 2003 RCT Chile

MethodsStudy design: RCT

Duration of study: March 2000 to March 2002


ParticipantsCountry: Chile

Income classification: Upper middle

Geographical scope: Deprived urban areas in Santiago

Healthcare setting: PC facility that were underfunded and insufficiently resourced

Mental health condition: Women with persistent depression

Population: Women

  • Age: 18-70 years
  • Gender: Female
  • Socioeconomic background: Majority were housewives from deprived areas
  • Inclusion criteria: Age 18-70 years with current major depression illness (2 screenings of GHQ-12 with a score > 5 at 2 weeks interval), female PHC patients
  • Exclusion criteria: Women who had psychiatric consultation or admission to a hospital in the 3 months before the baseline interview, current psychotic symptoms, serious suicide risks, history of mania, alcohol abuse


InterventionsStated purpose: To compare the effectiveness of a stepped-care programme with usual care in primary-care management of depression in low-income women in Santiago, Chile

INTERVENTION:

Name: Stepped care

Delivered by:

  • Title/name of NSHW/OPHR and number: PC physician and group leaders (non-medical worker)
  • Selection:Group leaders and doctors - both were employed in the local PHC units who were selected for the study
  • Educational background: Group leaders were a nurse or a social worker. The doctors had a medical degree
  • Training:Group leaders - 12 hours training by the principal investigator psychiatrist. Content - not specified. Doctors - 4 hours of training by psychiatrist to understand the brief pharmacotherapy protocol (medical algorithm of fluoxetine, amitriptyline, imipramine) and initial and follow-up assessments
  • Supervision: Group leader - 8 hours supervision by the principal investigator over the course of the intervention
  • Incentives/remuneration: Are none as they are employees


Intervention details:

  • Duration/frequency: Psychoeducation: 7 weekly sessions and 2 booster sessions (weeks 9 and 12) each lasting 75 minutes, groups of 20 participants
  • Content of intervention: Group leaders provides psychoeducation, which consists of information on symptoms, causes of depressions, treatments available, positive activities, problem-solving techniques, basic cognitive and relapse-prevention techniques; patients given a manual on session contents and examples/exercises. Follow-up by group leaders: monitoring medication adherence, attendance at follow-up visits for patients receiving pharmacotherapy. They also refer to the doctor if HDRS score > 12 at 6 weeks with psychoeducation. Doctors: detect and diagnose using their brief pharmacotherapy protocol and then prescribe according to the medical algorithm, and then follow-up the patients


CONTROL: Usual care: normally available services in PC clinic: included antidepressant medication, referral to specialist (usually takes 2 months to be seen by psychiatrist); given guidelines on treating depression in PC before initiation of study. No services restricted/with held

CO-INTERVENTIONS: None


OutcomesPatient: GHQ-12 screening, MINI, Diagnosis for DSM-IV, HDRS* - Severity of depression, SF-36 - scores for mental health, emotional role, social functioning, vitality.

Carer: None

Process/health worker outcomes: None

Economic outcomes: None

(* study's primary outcomes)

Time points: Baseline, 3 months, 6 months


NotesSource of funding: US National Institute of Mental Health

Notes on validation of instruments (screening and outcomes): All instruments validated

Additional information: Information from authors: no study protocol so unable to check primary and secondary outcomes

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: None (only National Institute of Mental Health proposal)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Randomisation of patients was stratified by clinic, done in blocks of 20 using computer-generated random number"

Comment: Probably done

Allocation concealment (selection bias)Low riskQuote: "Individuals who recruited patients were neither involved in nor aware of the procedure used to generate allocations. Allocations in numbered sealed envelopes in each clinic and opened by an individual who had not recruited patients"

Comment: Probably done

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Patients and personnel not blinded but unlikely to have any effect on outcome

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: None

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuotes:

"At baseline, a clinician administered the three assessments"

"Follow-up interviews were done by an independent clinician blinded to treatment assignment"

"Rates of participation in the intervention programme were high, and participation in blinded outcome assessments exceeded 85% in both groups"

Baseline outcome measurements similarLow riskComment: Similar baseline outcome measurements. No adjustment therefore needed

Baseline characteristics similar?Low riskComment: Similar baseline characteristics

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: 3 months: 18 (stepped care) vs 11 (usual care); 6 months: 16 vs 13 out of 120 patients in each group. This represents more than 80% follow-up rate

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskAuthor information: "There was a record kept [of adverse outcomes] but do not know where it is"

Protection against contaminationHigh riskComment: 3 clinics that can have both intervention and control people and the same GP could be delivering both interventions, so theoretical risk of contamination

Reliable primary outcome measuresLow riskComment: There is no mention of their being a reliability test/agreement between physicians in using the HDRS score or the SF-36. However, also low dropout rate

Selective reporting (reporting bias)Low riskComment: No protocol. Author suggests all outcomes reported

Other biasLow riskNone

Baker-H 2005 CRCT Jamaica

MethodsStudy design: Cluster RCT (unit of allocation: nutrition clinics; unit of analysis: mother/undernourished children dyad)

Duration of study: Not mentioned


ParticipantsCountry: Jamaica

Income classification: Upper middle

Geographical scope: Urban - parishes of Kingston and St Andrew

Healthcare setting: Recruited from nutrition clinics in government health centres but intervention undertaken at home

Mental health condition: Maternal (including postnatal) depression

Population: Mother-malnourished child dyads

  • Age: Mother: reproductive age: mean (SD): 26 years (7.1); child: mean age (SD): 18.4 months (4.5)
  • Gender: Female; child: both
  • Socioeconomic background: 40% completed high school, moderately crowded environments with few possessions and mean sanitation facilities
  • Inclusion criteria: Mothers of undernourished children enrolled in nutrition clinics in government health centres. All 12 nutrition clinics in the urban areas of the included parishes were included. Children: aged 9-13 months, weight-for-age < -1.5 (z score) and birthweight > 1.8 kg, singleton, absence of chronic disease or obvious disability
  • Exclusion criteria: Not specified


InterventionsStated purpose: To determine the effect of early childhood stimulation with undernourished children and their mothers on maternal depression

INTERVENTION:

Name: Early home stimulation programme

Delivered by:

  • Title/name of NSHW/OPHR and number: 18 CHAs
  • Selection: Paraprofessionals employed in government health centres. Selected by public health nurses in each clinic to be involved in the home stimulation programme. They were people whom the nurses thought would be interested and reasonably competent at the task
  • Educational background: Most CHWs would have either not completed high school or have completed high school with no examinations
  • Training: 5-day introductory workshop (over 4 weeks provided by government) conducted with CHAs before start of programme on health and nutrition. The study team provided an additional 2 weeks training covering child development, parenting issues and how to conduct the intervention. All CHAs received a manual and a set of homemade toys and these were used in the training. A further 4-day refresher training was held midway through the study
  • Supervision: The supervisor observed each CHA conduct a visit once a month and visited health centre every 2 weeks to discuss the programme and review the records of each visit. Supervised by main author (HBH) - degree in education and Master of Science from Centre of International Child Health and studying for Doctor of Philosophy degree at the time
  • Incentives/remuneration: Employed by government


Intervention details:

  • Duration/frequency: CHAs conducted house visits weekly for 30 minutes lasted for 1 year
  • Content of intervention: Home visits (demonstrating age-appropriate activities to improve mothers' knowledge and practices of child rearing/parental self esteem, encouragement, make sure they experience success, empathy)


CONTROL: Usual care: which is standard health and nutrition care (from nutrition clinics). This was also provided to intervention group

CO-INTERVENTIONS: As above (usual care)


OutcomesPatient: (Child) Griffiths Mental Development Scales*; child anthropometry: z scores (National Center for Health Statistics references) for height for age, weight for height and weight for age

Carer: (mother) CES-D* - for assessing frequency of depressive symptoms; Peabody Picture Vocabulary Test-Revised (for mother's vocabulary)

Process/health worker outcomes: None

Economic outcomes: None

(*: study's primary outcomes)

Time points: For mothers: baseline and 1 year follow-up


NotesSource of funding: Thrasher Research Fund, USA, with subsidiary grants from the British High Commission-DFID, Jamaica and the University of the West Indies Mona Campus Research and Publication Fund. The Ministry of Health Jamaica supported the CHAs

Notes on validation of instruments: Validated international instruments but not for the Jamaican population

Additional information: No published study protocol

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: None


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "The 12 clinics were stratified into two groups by size and randomly assigned to intervention and control groups. Preliminary investigation of records indicated that there should have been sufficient children attending the clinics in Kingston and St Andrew to fulfil the sample size requirements. However, fewer children were available than had been anticipated, especially in the centres assigned to intervention. Therefore six clinics in urban areas of the adjacent parish, St Catherine, were also enrolled. Four were randomly assigned to intervention and two to control, to ensure equal numbers of children in the intervention and control groups, making a total of 11 intervention clinics and seven control clinics"

Information from author: Using a computer generated, simple randomisation sequence

Comment: Despite extra clinics later assigned, this was done randomly

Allocation concealment (selection bias)Low riskInformation from author: Allocation done by an independent statistician

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: No blinding but this would not be feasible for such an intervention. Unlikely to affect outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: z score anthropometric measurements standardised and validated

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskComment: CED evaluation done by the interviewers and were unaware of the mothers' intervention status. For children, "assessed by one of two persons who tested equal numbers from each group and were unaware of the children's group"

Baseline outcome measurements similarLow riskComment: All similar

Baseline characteristics similar?High riskComment: In the intervention group  more fathers live at home (30 vs. 21%) and more mothers completed high school (28 vs. 23%). This may add to the support of the mothers, but it is unlikely to have a large effect on the outcomes because baseline outcomes are similar. However, these differences are not adjusted for in the summary statistics

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: Intervention 64/70 completed follow up and for control 61/69; This is more than 20% completion rate

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No adverse events reported

Protection against contaminationLow riskComment: This is a cluster trial so patients unlikely to discuss the intervention

Additional information from author: The CHAs did not have training together in groups at the time so they would not have come into contact with CHAs from control clinics in a formal setting

Reliable primary outcome measuresHigh riskQuote: "The test-retest (intraclass correlation coefficient) for the depression scale over a two week period was R=0.71 (n=20).The internal reliability (Chronbach’s alpha) of the scale was a = 0.90 (n = 125). Two interviewers administered the questionnaires in the study; they were unaware of the mothers’ intervention status. Interobserver agreement was .90% for each question (n = 22)"

Comment: Reliable tools and interobserver agreement and interviewers unaware of allocation status. However, the CES-D instrument has not been validated in the Jamaican population and does not measure clinical depression, rather depressive symptoms. Several of the mothers may not have been depressed. The reliability of these figures for assessing depression levels is low

Selective reporting (reporting bias)Low riskComment: Child outcomes are reported in a subsequent paper that author sent to me Powell 2004

Other biasLow riskComment: No other bias detected

Bass 2012 CBA Indonesia

MethodsStudy design: CBA study, unit of allocation by geographic area and unit of analysis by individual

Duration of study: August 2007 to January 2008 


ParticipantsCountry: Indonesia

Income classification: Lower-middle

Geographical scope: Rural, 6 villages around the central town of Bireuen District in Aceh, selected for having historically high rates of torture and where other NGOs were not currently providing services. Villages were paired based on distance from the urban district centre. This district was considered 1 of the strongholds of the Free Aceh Movement (Gerakan Aceh Merdeka (GAM) and these villages were frequently attacked by the Indonesian military throughout the 1980s and 1990s. These populations are situated far from the sea and were not directly affected by the disastrous effects of the 2004 tsunami. They were, however, affected by the unequal distribution of resources provided to the tsunami survivors, which according to the United Nations led to local discontent and perceptions of inequality with regard to international aid distribution 

Healthcare setting: Community groups

Mental health condition: Anxiety and depression. As PTSD cardinal symptoms did not come up much, they did not measure PTSD. 

Population: Adults

  • Age: > 18 years, most aged 30-69 years
  • Gender: Both
  • Socioeconomic background: The populations in the study villages were exposed to systematic human rights violations, with entire villages experiencing torture through direct experience, torture of family members, witnessing of torture and arbitrary killings, or a combination of these. Majority were married (79%)
  • Inclusion criteria: Total symptom scale > 38 and eligible cases also had to indicate at least some level of functional impairment, as assessed by a score (0 on either the local function or the adapted WHODAS II measure)
  • Exclusion criteria: Not specified


InterventionsStated purpose: 1. to investigate the impact of the group counselling intervention on reducing the severity of mental symptoms and associated dysfunction. 2. to investigate potential moderating effects of gender and age because the literature in general, as well as recent cross-cultural studies, have shown some differential effects of gender and age with certain treatments

INTERVENTION:

Name: Problem-Solving Counseling (PSC) programme

Delivered by:

  • Title/name of NSHW/OPHR and number: RATA (A local torture survivor and treatment organisation) counsellors, number not specified
  • Selection: Local lay individuals
  • Educational background: No formal degrees or education prior to training
  • Training: Initial 5-day training by ICMC (International Catholic Migration Commission) on the programme components. They then provided individual counselling to torture survivors in non-study communities for 3 months to improve their skills with regular supervision to ensure proper implementation. This was followed by a second period of training on implementing the programme in a group format, including skills for group management. The group intervention was provided by pairs of counsellors working together. The manualised training was developed by ICMC Indonesia: topics such as qualities of an effective helper, confidentiality, empathy, listening and responding, questioning and problem management skills, stress and coping, and information specifically on the consequences and needs of torture survivors, featured
  • Supervision: Group and individual counsellor supervision was provided throughout the study, not specified by whom
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: 8 weekly group sessions. Duration of intervention 4 months: September to December 2007


  • Content of intervention: Talking groups/group counselling in community settings. Client-guided problem-solving approach to the problems selected by the group of clients at the time the groups were created (non-specific counselling). Sessions 1 and 2: introduction of intervention, expectations, current problems related to distress identified. Study participants selected the focal problems. Sessions 3-6: discussions, sharing experiences, coping strategies identification and participants through discussions lead to understand how to cope; session 7: self evaluation of positive and negative changes; session 8: looking towards the future; conducted by 2 counsellors due to training purposes "the process was designed so that if it became necessary to replace a counsellor, new counsellors would be trained and then matched with more experienced counsellors to continue running the groups"


CONTROL: Wait-list control

CO-INTERVENTIONS: Change in service delivery. Prior to the initiation of the intervention, the counsellors conducted programme introduction sessions in the community (called socialisation sessions) in each study village, to introduce the community to the organisation and the services that would be provided. This was done to improve the acceptance of these services within the community and inform potential participants of the dates on which the interviewers would conduct the eligibility screenings. These community presentations were open to everyone in the village


OutcomesPatient: Adapted HSCL - severity of depression and anxiety); adapted WHODAS II; newly developed scale on coping mechanisms (coping); local function scale; SCL somatic WHO scale (somatic symptoms)

(for screening: total symptom scale (a combination of all 3 scales mentioned under instruments for assessment)

Carer: n/a

Process/health worker outcomes: None

Economic outcomes: None

Time points: Baseline, 1 month pre intervention, 1 month post intervention (5 months following baseline)


NotesSource of funding: Victims of Torture Fund at USAID

Notes on validation of instruments (screening and outcomes): For adapted HSCL, SCL, and local function scale: qualitative study done applying free listing and key informant qualitative interviewing to identify local signs and symptoms that mapped on to domains of anxiety, depression and somatoform disorders, these were used to draft the assessment of the 44-item questionnaire; it is unspecified if validated in the local setting. Local function scale also only validated during study in a pilot study and Pearson's coefficients done

WHODAS: adaptations using elements of Bolton and Tang (26) and other groups (20,27,28). Items that population identified during prior qualitative study as typical daily carer tasks/community activities

Coping scale: based on qualitative study

Additional information: Contact for protocol

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: None given


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "A local torture survivor and treatment organization (RATA) helped identify potential study villages, selecting those with historically high rates of torture and where other NGOs were not currently providing services and therefore the need was greatest. Villages were paired based on distance to the urban district center. Table 1 presents the population structures of the study villages. The designation of intervention or control status was made in discussion with ICMC and RATA staff, who had to consider which villages would be more or less accessible during the rainy season in which the first round of services were provided, with more accessible villages given priority as intervention sites"

Allocation concealment (selection bias)High riskComment: This was a CBA study

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Not done but unlikely to affect outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: None

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote: "The designation of intervention or control village was not shared with the interviewers until after data collection was complete, preventing any knowledge of which villages would get services first from biasing the baseline assessments"

Baseline outcome measurements similarHigh riskQuote: "The symptom scales are similar across the intervention and control groups, while the functional impairment levels differ, with the controls having higher rates of impairment among both men and women." Differed for females on local functions scale and for all on WHODAS items (both for all eligible participants and for those actual participants who took part in ≥ 2 sessions)

Baseline characteristics similar?Low riskComment: All similar

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: 79% (333/420) of those eligible completed the full study. This is close to 80% so is likely to be representative. In addition, baseline characteristics and outcomes did not differ significantly between all eligible participants and these actual participants

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
High riskComment: Poorly powered study and 1 outcome (social functioning in women) seems to have a detrimental effect in women. No adverse outcomes specifically reported

Protection against contaminationLow riskComment: Clusters of interventions and controls (controls are also hard to access), so unlikely contamination

Reliable primary outcome measuresHigh riskQuote 1: "With regard to reliability, correlation coefficients were adequate at 0.65 for the anxiety subscale, 0.68 for the somatic subscale, and strong at 0.91 for the depression subscale. Cronbach alpha scores (a measure of internal reliability) ranged from 0.81 to 0.87 for the three scales. Alpha scores of 0.70 generally indicate adequate internal consistency"

Quote 2: "Adjusted for baseline symptom score, sex, age and group clustering"

Quote 3: "In our power calculations, we did not take the group clustering into account, and thus we may have underestimated the sample size required to show significant differences between the program conditions. However, an analysis of the intra-class correlation coefficients indicates that the variance due to clustering was minimal, thereby not affecting the comparisons significantly" 

Selective reporting (reporting bias)Unclear riskComment: No protocol so unknown if there is selective reporting

Other biasHigh riskComment: In addition, villages selected for intervention group were more accessible to study team. This could have introduced biases due to unknown factors associated with ease of access

Berger2009 CRCT SriLanka

MethodsStudy design: Cluster RCT (unit of allocation: school setting; unit of analysis: individual patient)

Duration of study: February to May 2006 


ParticipantsCountry: Sri Lanka

Income classification: Low income

Geographical scope: Southern coast of Sri Lanka, small town of Welligama

Healthcare setting: Schools

Mental health condition: PTSD

Population: Children/adolescents

  • Age: 9-14 years school
  • Gender: Both male and female
  • Socioeconomic background: Almost all the children in this school lost their homes and many lost family members or relatives in the tsunami
  • Inclusion criteria: Aged 9-14 years; all exposed to tsunami
  • Exclusion criteria: Not specified


InterventionsINTERVENTION:

Name: ES-Sl (ERASE Stress Srilanka)

Delivered by:

  • Title/name of NSHW/OPHR and number: 12 home-room teachers  (12 trained but 6 took part in intervention and 6 in wait-list control)
  • Selection: Teachers at the chosen school
  • Educational background: Primary and secondary school teachers
  • Training:  ES-Sl course 3 days of 8-hour training (24 hours in total). Trainers were study researchers too
  • Supervision: Throughout the application of the programme, teachers were supervised on a weekly basis by 2 local mental health professionals previously trained by the researchers to insure programme fidelity; monitoring protocol adherence done by trainers). During the first 2 sessions of the intervention, all teachers in the active group participated in two 3-hour supervisory sessions delivered by the trainers and assisted by 2 local mental health professionals to insure reliability of application of the protocol and to overcome potential problems. Adherence to protocol was monitored during these sessions, which included a point-by-point discussion of the training procedure by the trainers. Because the trainers could not remain in Sri Lanka for the entire intervention period, further fidelity was monitored by the local professionals and by periodic phone and Internet supervision with the first author (R.B.)
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: The twelve 90-minute sessions (18 hours) delivered on a weekly basis
  • Content of intervention: Each teacher in charge of 1 class only (12-16 students). The 12 sessions included homework review, warm-up exercises, experiential group activity, psycho-educational presentations, practical coping skills training, and a closure exercise followed by a new home assignment. Each teacher was given a manual


CONTROL: Wait-list religious class control but where teachers had received the training for the intervention at baseline (risk of spillover effect). Due to perform intervention on other 6 classes the following year

CO-INTERVENTIONS: As above (usual care)


OutcomesPatient: (Child) 1. 2 objective exposure-related questions analysed as 2 Guttman scales §; 2. subjective exposure: Pat - Horencyck  questionnaire §; 3. Significant distress, helplessness and horror: 3 questions querying whether participants experienced any of those emotions as related to the tsunami, using a 5-point scale from 1 (did not experience this emotion at all) to 5 (experienced this emotion often). So as to avoid overinclusion, 1 score of at least 4 was necessary to fulfil criterion A2 of PTSD §; 4. major trauma life questionnaire §; 5. UCLA PTSD index; 6. subjective functional impairment: 7 items derived from the Child DIS. 5-point scale ranging from 1 (not at all impaired) to 5 (very much impaired); 7. Somatic complaints related to terrorism: 5 yes/no categorical items from the Diagnostic Predictive Scales §; 8. Hope: 6-item self report questionnaire §; 9. Depression: 7- item brief BDI

Carer: None

Process/health worker outcomes: None

Economic outcomes: None

(*: primary outcomes; §: outcomes that we have not reported in this review)

Time points: None


NotesSource of funding: Not specified

Notes on validation of instruments: Instruments 1, 2 and 4 are not validated. Instrument 3 only validated in Israeli settings. 5. UCLA PTSD index: validated in Sri Lankan population). Instruments 6-9: internal reliability only for current setting, validated elsewhere in other settings (Beck 1974; Lucas 2001; Snyder 1997)

Additional information: None

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Not specified


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "The randomisation procedure was done by coin tossing and choosing 1 class for each age group"

Allocation concealment (selection bias)High riskComment: There was no allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: There was no blinding of teachers or students but this is unlikely to affect outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote: "Local trained volunteers blinded to the experimental conditions administered questionnaires"

Baseline outcome measurements similarLow riskQuote: "Further analyses show no difference in outcome measures at the first assessment between the ES-SL and WL [wait-list] groups ( table 1)"

Baseline characteristics similar?Low riskQuote: "No differences between the ES-SL experimental group and the WL [wish-list] control group were found for gender, grade level and personal or important other exposure to tsunami" 

Incomplete outcome data (attrition bias)
Efficacy data
Low riskQuote: "There were no missing data"

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No safety outcomes/adverse events reported in this study

Protection against contaminationHigh riskQuote: "There may have been a spillover effect since all the homeroom teachers participated in the training"

Reliable primary outcome measuresHigh riskComment: UCLA PTSD index validated in Sri Lankan population; BDI, hope and DPS (somatic), and CDIS (functional impairment) validated in other settings but only have internal reliability scores in this setting/study. No internal reliability data or validation for other local scales/questionnaires. That is many tools have not been validated in local context. All apart from PTSD may not be reliable

Selective reporting (reporting bias)Unclear riskComment: Not mentioned and not able to find protocol

Other biasHigh riskComment: High risk as clustering error not adjusted for

Bolton 2003 C-RCT Uganda

MethodsStudy design: Cluster randomised, parallel group, gender-stratified, controlled clinical trial (unit of randomisation: village; unit of analysis: individual)

Duration of study: February 2002 to July 2002; 6-month follow-up completed in January 2003


ParticipantsCountry: Uganda

Income classification: Low income

Geographical scope: 30 villages in Rakkai Province and contiguous half of Masaka province in South West Uganda; rural

Healthcare setting: Community (community centres, churches, open spaces)

Mental health condition: Depression (DSM IV depression and sub-syndromal depression)

Population: Patients

  • Age: Adults (> 18 years); mean age ranged from 27 years (SD 13.5) to 66 years (SD 10.5)
  • Gender: Both (stratified for gender)
  • Socioeconomic background: Not stated except for education (mean 4.7 years (SD 2.8) Intervention; 3.9 years (SD 3.3) control)
  • Inclusion criteria: A 3-stage screening: Stage 1: (by trained local World Vision staff) identified 20 people from the selected 15 villages (8 for males and 5 for females) with depressive symptoms in local idiom; Stage 2: same interviews visited identified people, and if they admitted to having 1 of 2 locally approximate depressive conditions, informed consent was sought; Stage 3: eligibility expanded to include sub-syndromal depression by DSM IV criteria (less 1 DSM criterion); screening for depression was done by 10 trained and experienced local World Vision staff using a composite instrument (Bolton 2004) consisting of the HSCL (to assess depressive symptomatology and diagnose DSM IV Major Depression (excluding criteria related to exclusion of medical causes and drug effects) using a previously validated algorithm), a locally developed culturally appropriate instrument to assess functional impairment (separately for women and for men), and ethnographically validated questions that assessed significant distress and duration of depression
  • Exclusion criteria: Absence of symptoms of depression; age < 18 years, unwillingness to meet weekly (additional criteria revised after screening commenced) people very different in age from the rest included in a village; and those appearing currently suicidal


InterventionsStated purpose: To test the efficacy of a manual-based, time-limited group psychotherapeutic approach in relieving depressive symptoms and improving functioning; and to demonstrate that psychotherapy trials are feasible in Sub-Saharan Africa

INTERVENTION:

Name: Group Interpersonal Therapy for Uganda (IPT-G-U), 116 people (of 163 in 15 villages originally randomised, and 139 invited to participate; 107 completed intervention and follow-up);

Delivered by: NSHW/LHW

  • Title/name of NSHW/OPHR and number: Group leader (9/10 who completed training)
  • Selection: Local person of the same sex as the sex-segregated group; non-clinicians fluent in English and Luganda employed by World Vision
  • Educational background: Completed high school (college-level)
  • Training: Duration: 2 weeks intensive training. Trained by 2 faculty members of the New York State Psychiatric Institute (members of the team led by Myrna Weissman that developed ITP and the Group adaptation of IPT) assisted by a trained psychologist and an experienced group therapist employed by World Vision. Content of training: participating in local adaptations of the IPT manual; explanations of the treatment process and the contract; explanations of the role of group leaders in helping members in identifying problem areas and discussing locally acceptable variations to absolute confidentiality; identification of, and agreement about, interpersonal problem areas likely to be encountered in group work according to the 4 domains in IPT; using the principles of IPT to identify personal problems and supporting each other to find options and in implementation. Format: didactic teaching and experiential group processes with role plays and group exercises
  • Supervision: By local World Vision mental health professionals involved in training; format and duration not described
  • Incentives/remuneration: Weekly payment for 16 weeks (amount not stated)


Intervention details:

  • Duration/frequency: 16 weekly 90 minute sessions
  • Content of intervention: Group work led by group leader who first diagnoses depression; works with group member to identify problem areas associated with current symptoms and identify the 4 areas of interpersonal difficulties that served as triggers for the depression; weekly review of mood and encouragement of participant's description of events that could link to the mood; facilitation of support and solutions from group members.


CONTROL: Treatment as usual (treatment by local traditional healers, no treatment, or in rare cases, hospitalisation),138 people (of 178 randomised in 15 villages and 145 invited to participate; 117 completed intervention and follow-up)

CO-INTERVENTIONS: No restrictions on additional interventions (utilisation and nature of any not described)


OutcomesPatient: Screening: HSCL and local functional impairment scale. Outcomes: Prevalence of DSM IV Major Depression (excluding criteria related to exclusion of medical causes and drug effects (using Mollica DSM-IV algorithm for A, C and E criteria)*; HSCL mean scores; Functional Impairment scores (sex-specific 9-item questionnaire); depression in subgroups continuing informal group meetings between 2 weeks and 6 months versus subgroup not meeting after group intervention

Carer: Not applicable

Process/health worker outcomes: No direct outcomes reported: indirect outcomes are the results of the trial

Economic outcomes: Not reported

Time points: Initial assessment 2 weeks after intervention; follow-up at 6 months

(*: primary outcomes)


NotesSource of funding: Supported by World Vision, Washington, DC; Psychotherapy Core of the Child Intervention Research Center Columbia University (NIMH grant #5P30 MH60570); Center for International Emergency Disaster and Refugee Studies, Johns Hopkins Bloomberg School of Public Health; Mellon Foundation

Notes on validation of instruments (screening and outcomes): All screening instruments and outcome measures locally adapted and validated in previous exercises and published; the HSCL scale consisted of 14 items, with 4 responses for each item related to the degree of distress due to a particular symptom (range 0-42 points); higher scores indicate more severe depression; the function scale consisted of 9 items with 5 responses for each item indicating degree of difficulty in completing the activity (range 0-36 points); higher scores indicate more dysfunction

Additional information: IPT attendance was high: 54% attended at least 14/16 sessions; 4% attended ≤ 10 sessions

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Not prospectively registered


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote from report: "Random assignment was performed by enumerating the villages and using a random number table to determine study allocation"

Comment: Cluster randomisation of 30 villages to 15 in each arm was done using a random number table; the 30 villages of 154 eligible villages were chosen for a previous prevalence study (Bolton 2002, unpublished) that used weighted random sampling based on government census data

Allocation concealment (selection bias)Unclear riskQuote from report: "Each list began with those who met the original diagnostic criteria, followed by those who fell short by a single criterion, in order of decreasing depression score. Interviewers visited each person in the order they appeared on the list. The interviewer re-read the consent form, advised the person about the study group to which their village had been allocated, and asked them to confirm their willingness to continue in the study. Interviewers continued down the list until they had at least 8 participants (at which point they did not contact the remainder of the list) or until they reached the end of the list"

Comment: Allocation of participants was not concealed though cluster randomisation of villages was the unit of randomisation; the eligibility criteria were modified to exclude people whose age varied widely from the rest of those selected in each village to ensure better outcomes with group IPT (based on previous experiences)

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Participants and personnel were not blinded; however, cluster randomisation would ensure minimal risk of performance bias since villages where intervention was given were separate from villages randomised to usual care

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: There were no objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote from report: "The baseline assessments were conducted in the villages, with the randomisation of village groups to intervention or control or control status done afterwards to ensure that interviewers were not aware of participant trial status at baseline. In an effort to keep interviewers unaware of the participants’ intervention status, the post-intervention and 6-month follow-up assessments were conducted at a centrally located community centre. At these assessments, trial participants were transferred from their villages and were asked not to divulge either their village of origin or their treatment assignment status. To reduce measurement error that might have arisen from different interviewing styles, study participants were interviewed by the same interviewer at each stage of the study"

Comment: The period from recruitment to first assessment was 18 weeks and to second assessment was a further 6 months. There is a possibility that the recruiter (who did not administer the intervention) may have guessed allocation for the first assessment in a few instances but this unlikely to have altered results significantly given the magnitude of the differences in results between groups

Baseline outcome measurements similarLow riskQuote from 6-month follow-up report: "At baseline 86% of participants in the intervention group met the modified diagnostic criteria for major depressive disorder and 94% of those in the control group met these criteria (prevalence difference was not significant)"

Quote from primary report: "However, there was a significant difference in the proportions who met the original depression diagnostic criteria, both among those who completed the study and all those on the original lists of eligible participants (TABLE 1). (Tests for differences in baseline characteristics were performed using standard significance tests and were not adjusted for cluster effects. However, because we found a positive correlation between clusters, adjusting for cluster effects would tend to reduce variance and cause group differences to be even less significant than the values reported herein)"

Comment: Discrepancy in interpretation of baseline differences in the 2 reports; results adjusted for clustering and for baseline outcome differences

Baseline characteristics similar?Low riskComment: No differences in age or education, or symptoms duration

Incomplete outcome data (attrition bias)
Efficacy data
Low riskQuote from 6-month follow-up report: "Six months after the post-intervention 103 (96%) of the 107 participants in the intervention group who completed the trial and 113 (97%) of the 117 completed the trial and 113 (97%) of the 117 controls were reassessed"

Comment: Attrition was high in both groups due to the 3-stage screening process; however, 116/163 eligible and randomised to IPT consented to participate; 132/178 randomised to control consented to participate) results did not differ in completer analyses and in 2 sets of ITT analyses

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No safety data reported

Protection against contaminationLow riskComment: Cluster randomisation of intervention arms precluded contamination

Reliable primary outcome measuresLow riskComment: Culturally adapted and validated measures used

Selective reporting (reporting bias)Low riskComment: Trial not prospectively registered, but all pre-stated outcomes were reported

Other biasLow riskComment: No other biases were detected

Bolton 2007 RCT Uganda

MethodsStudy design: Randomised, parallel group, assessor blinded, 3-armed, clinical trial

Duration of study: May 2005 to December 2005


ParticipantsCountry: Uganda

Income classification: Low income

Geographical scope: 2 camps (Awer and Unyama) for internally displaced people near Gulu town in northern Uganda; semi-rural; > 20,000 inhabitants each; minimal socioeconomic facilities

Healthcare setting: Group meetings

Mental health condition: Anxiety, depression, conduct problems and some PTSD symptoms

Population: Adolescents

  • Age: 14-17 years
  • Gender: Both
  • Socioeconomic background: Acholi youth from socioeconomically deprived backgrounds living in camps for displaced youths
  • Inclusion criteria: Age 14-17 years, scored > 32 on depression scale; > 0 on the function scale; had symptoms > 1 month; camp resident for previous month
  • Exclusion criteria: Inability to be interviewed due to physical or cognitive difficulties, severe suicidal ideation or behaviour


InterventionsStated purpose: To assess effect of locally feasible interventions on depression, anxiety and conduct problem symptoms among adolescent survivors of war and displacement in northern Uganda

INTERVENTION 1:

Name: G-IPT (psychotherapy-based intervention); 105 people randomised (103 enrolled)

Delivered by: LHW

  • Title/name of NSHW/OPHR and number: G-IPT facilitator; 12 people
  • Selection: Same gender as groups; local Acholi, spoke both English and the local language Luo, and had minimal previous mental health intervention experience
  • Educational background: Not stated
  • Training: 2 weeks of intensive training by Columbia University faculty using a locally adapted G-IPT treatment manual (unpublished)
  • Supervision: Weekly direct supervision by World Vision Uganda staff and weekly phone supervision of written case notes for adherence to study protocol with study personnel in the US; supervisors had previous IPT experience and received weekly telephone supervision with US trainer
  • Incentives/remuneration: Not stated


Intervention details:

  • Duration/frequency: 16 weekly group meetings lasting 90-180 minutes (preceded by 1-2 individual meetings to explain treatment and draw up a treatment plan)
  • Content of intervention: 6-8 same sex groups of adolescent Acholi youths per facilitator; manualised G-IPT based on the concept that depressive episodes are related to difficulties in 1 or more of 4 interpersonal areas: grief, interpersonal disputes, role transitions and interpersonal deficits. The focus is on improving depressive symptoms and functioning by identifying the interpersonal problems most relevant to the current depression and assisting the individual in building skills to manage those problems. "The flow and organization of the IPT-G sessions was organized in three phases: The initial phase (corresponding roughly to sessions 1-4) focused on building rapport, setting personal treatment goals and learning to identify mood states. The middle or working phase (corresponding roughly to sessions 5-12) involved exploring major issues related to grief, transitions, disputes and building interpersonal skills and connections among group members. The final, closure phase (corresponding roughly to sessions 13-16) was dedicated to preparing for the end of the IPT-G intervention and the close of formal group meetings. During this final phase, participants in the IPT-G intervention groups were encouraged to discuss how they might continue to provide support and connection to one another after the formal ending of the group (if this topic arose naturally)"


INTERVENTION 2:

Name: Creative play (activity based intervention); 105 people randomised (99 enrolled)

Delivered by: NSHW

  • Title/name of NSHW/OPHR and number: Creative play facilitator, 2 people
  • Selection: War Child Holland staff (selection not described)
  • Educational background: Not stated
  • Training (contents, duration and by whom): Not stated
  • Supervision: Weekly or bi-monthly supervision by War Child Holland psychosocial specialist who reported bimonthly by telephone with US study personnel
  • Incentives/remuneration: Not stated


Intervention details:

  • Duration/frequency: 16 weekly group meetings lasting 90-80 minutes (preceded by 1-2 individual sessions where treatment was explained)
  • Content of intervention: 4 groups (2 per camp) of 25-30 adolescents of both genders per group; based on War Child Holland manual adapted for adolescents with depression; for war-affected youth, based on the premise that a youth’s resilience is strengthened by verbal and nonverbal expression of thoughts and feelings through age-appropriate creative activities such as, songs, art, role plays, music, sports, games and debates. Each activity served specific psychosocial goals and after the activities, facilitators led discussions on what the participants and facilitators thought about the activity as a means of drawing real-life lessons. "Sessions 1-4 focused on getting to know one another and setting the group rules. Sessions 5-12 were more in-depth and focused on issues in the group, in particular the interrelationships between the adolescents in the group and developing opportunities for self-expression. Sessions 13-15 were dedicated to closure and preparing for a closing inter-generational event. The final CP [creative play] session (session 16) was an inter-generational event where caregivers were invited to attend along with the young people. This final session at each camp was hosted by one of the young people serving as Master of Ceremonies and facilitated by the participating young people themselves. The youth facilitated some of their CP activities for the family members who attended"


CONTROL: Wait-list controls, 104 people (102 enrolled); received no specific intervention but were free to access any services or programmes that they would have received in the absence of the study

CO-INTERVENTIONS: Not stated


OutcomesPatient: (Locally developed) Acholi Psychosocial Assessment Instrument depression symptom scale scores*; improvements in anxiety symptoms, conduct problems and functioning on the APAI (minimum score for clinically significant symptoms on the APAI = 32; maximum score 105; higher scores = more symptoms); functional impairment scores: (range 0-36 for girls (9 items) and 0-20 for boys (5 items) with higher scores representing a greater degree of impairment); qualitative interviews §

Carer: Not applicable

Process/health worker outcomes: Not assessed

Economic outcomes: Not reported

(*: primary outcomes; §: outcomes that we have not reported in this review)

Time points: Baseline, 2 weeks to 1 month of completing interventions


NotesSource of funding: World Vision and War Child Holland; the Ruth and David Levine Foundation

Notes on validation of instruments (screening and outcomes): APAI locally developed: Scale reliability and validity were evaluated for a sub-sample (178 people) of the adolescents interviewed for trial eligibility (667 people). Cronbach alpha (a measure of internal reliability) was 0.92. Concurrent validity established by comparing depression symptoms scale scores between cases and non-cases identified by carer-youth pairs and threshold scale score of 32 identified (1 SD below mean score for cases); Test-re-test reliability for the depression symptom scale was 0.84 (in 30 of convenience sub-sample re-administered the APAI after 5 days)

Additional information (e.g. provide by authors, existence of a published study protocol):None

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Not prospectively registered


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Eligible youths were then randomly assigned to a study group. Random allocation was done by computerized generation of a random number between 1 and 400 for each eligible participant, ordering them by number and assigning the first third to IPT-G, the second third to CP and the final third to the wait-control group." "Of the total sample screened (N = 667), 300 individuals met original inclusion criteria, were stratified by camp and sex, and randomised to a study group. Of these 300, 290 were enrolled in the study. Of the remaining 10 individuals, 1 was already involved in the CP program in a neighbouring camp, 4 could not be located, and 5 refused. To meet our original sample size (300), we randomised an additional 38 individuals whose depression symptom scores were between 28 and 31 points. This relaxation of a trial eligibility criterion is acceptable when study design consequences are minimal.19 The first 14 individuals all consented and therefore, the remainder were not approached"

Comment: Very few people are in this non-randomised group. unlikely to make any difference to the outcomes

Allocation concealment (selection bias)Unclear riskQuote: "Eligible youths were then randomly assigned to a study group. Random allocation was done by computerized generation of a random number between 1 and 400 for each eligible participant, ordering them by number and assigning the first third to IPT-G, the second third to CP and the final third to the wait-control group"

Comment: Not specified who allocated them and whether the allocation was concealed to them; however, there were no major differences in baseline prognostic variables or outcome measures

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: No blinding of participants or personnel but unlikely to affect outcome

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote from report: "Interviewers were blinded to interviewees' intervention status"

Comment: Outcome assessor were blinded to allocation

Baseline outcome measurements similarLow risk

Baseline characteristics similar?High riskComment: Except for a slightly older age among wait-list controls, the 3 study groups did not vary significantly, but age not adjusted for in statistical analysis

Incomplete outcome data (attrition bias)
Efficacy data
Low riskQuote: "The study instrument was re-administered to 282 (90%) of the original 314 participants within 1 month of completing both interventions"

Comment: 304/314 enrolled and 261 (82 + 89 + 90), i.e. 83% completed analysis

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: None reported or mentioned in the paper

Protection against contaminationHigh riskComment: Only 2 camps chosen with refugee settings. Likely to be contamination (no clustering)

Reliable primary outcome measuresLow riskComment: Acceptable scores for APAI on criterion and concurrent validity; internal reliability and test-re-test reliability

Selective reporting (reporting bias)Low riskComment: All outcomes found over both report and paper though conduct not reported in published article. These were available when asked for from author

Other biasLow riskComment: None detected

Brown 2009 CBA Rwanda

MethodsStudy design: CBA study

Duration of study: Late 2003-2006


ParticipantsCountry: Rwanda

Income classification: Low income

Geographical scope: Gikongoro province in rural south-western Rwanda, 1 of the poorest regions of the country where World Vision Rwanda had begun a basic needs programme (providing range of goods and services) for youth-headed households in 2001

Healthcare setting: House-hold level

Mental health condition: Grief, depression

Population: Youth who head households (because of the AIDS pandemic and genocide)

  • Age: 12-24 years
  • Gender: Both
  • Socioeconomic background: Poor, about 50% have < 3 years' education
  • Inclusion criteria: Age 12-24 years, had to be heads of their households
  • Exclusion criteria: Not mentioned


InterventionsStated purpose: Study tested a model of adult mentorship and support to improve psychosocial outcomes among youth-headed households

INTERVENTION:

Name: Mentoring programme

Delivered by:

  • Title/name of NSHW/OPHR and number: 156 adult mentor volunteers (60% male)
  • Selection: Through nomination from youth who serve as heads of households and other trusted community members in the project area
  • Educational background: Not specified
  • Training: 1-week training where psychosocial skills and child development knowledge was imparted. Not specified whom
  • Supervision: Mentoring committee and world vision group. Not specified who exactly and how often
  • Incentives/remuneration: Travel reimbursement, small income generating skills given. No cash allowance


Intervention details:

  • Duration/frequency: 18-month intervention (2004-2006): mentors visited at least twice every month for a period of 2-3 hours at each home
  • Content of intervention: 1. Monitoring of youth well-being, "gave them love, attention and encouragement, provided guidance, transferred life skills and helped to ensure their health and safety". 2. Advocacy on behalf of vulnerable youth "speaking in public forums and encouraging other community members to support them (e.g. neighbours of the households they visited)"


CONTROL: Basic needs programme without mentors

CO-INTERVENTIONS: Basic needs programme


OutcomesPatient: Survey with 4 scales: grief §, marginalisation §, adult support § (unvalidated) and a depression score* (validated)

Carer: Not relevant

Process/health worker outcomes: None

Economic outcomes: None

(*: primary outcomes; §: outcomes that we have not reported in this review)

Time points: Baseline and follow-up after 2 years


NotesSource of funding: US Agency for International Development

Notes on validation of instruments (screening and outcomes): As above: survey scales unvalidated except for depression score (Bolton 2001)

Additional information: None

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Not found


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskComment: Non-random method was used. It was a CBA study   

Allocation concealment (selection bias)High riskComment: There is no randomisation of allocation of districts or allocation of concealment. These were chosen according to those delivering basic needs programme (convenience). and in discussion it mentions that 1 of the districts was closer to World Vision headquarters so may account for the difference in baseline outcomes and characteristics

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: It is not possible to blind participant or personnel for such an intervention and outcome unlikely to be affected by blinding

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Unclear riskQuote: "Even though the intervention group was worse off on many key variables relative to the comparison group at baseline, for most of the outcomes the intervention group improved, whereas the comparison group remained unchanged or in some cases worsened" 

Comment: There is insufficient information on who the researchers were who assessed the outcomes

Baseline outcome measurements similarLow riskQuote: "The intervention and control groups were not equivalent at baseline with respect to key background and outcome variables: the intervention group was significantly older (21 years vs. 20 years, p < 0.001) and significantly worse off than the comparison group on many outcomes, including having less adult support, greater marginalisation and higher levels of grief and depression. These differences may be explained partially by the higher levels of parental loss due to genocide also found in these areas. However, the intervention group had significantly higher levels of education and asset ownership and had received a greater number of services from WVR than the comparison group, a difference which may be attributable in part to the fact one of the two districts within the intervention group was in closer proximity to a main town and WVR offices"

Comment: These differences were controlled for in regression analyses

Baseline characteristics similar?Low riskQuote: "The intervention and control groups were not equivalent at baseline with respect to key background and outcome variables: the intervention group was significantly older (21 years vs. 20 years, p < 0.001) and significantly worse off than the comparison group on many outcomes, including having less adult support, greater marginalisation and higher levels of grief and depression. These differences may be explained partially by the higher levels of parental loss due to genocide also found in these areas. However, the intervention group had significantly higher levels of education and asset ownership and had received a greater number of services from WVR than the comparison group, a difference which may be attributable in part to the fact one of the two districts within the intervention group was in closer proximity to a main town and WVR offices"

Comment: These differences were controlled for in regression analyses

Incomplete outcome data (attrition bias)
Efficacy data
High riskQuote: Attendance "was not always possible, due to changes in household formation associated with marriage and migration"

Comment: Of 692 included in first survey, 593 were in the follow up sample. This is more than 20% dropout rate

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No adverse outcomes reported

Protection against contaminationLow riskComment: Allocation by districts so unlikely to be any contamination

Reliable primary outcome measuresHigh riskComment: The outcome is obtained from key psychosocial outcomes measuring scale: 1. perceptions of adult support, 2. marginalisation, 3. grief and 4. symptoms of depression. Alpha level over 0.65 considered acceptable. Grief alpha: 0.66; adult support; 0.85; marginalisation: 0.77; depression: 0.86. There is moderately good inter-rater reliability (except for grief) for these scores though they were not validated

Selective reporting (reporting bias)Low riskComment: Every aspect was reported mentioned in methods was reported. There is no access to a study protocol to check

Other biasHigh riskComment: The participants received a token incentive after the interview. This could have made much difference to the outcomes

Chen 2000 RCT Taiwan

MethodsStudy design: RCT

Duration of study: Not mentioned


ParticipantsCountry: Taiwan, China

Income classification: Middle income

Geographical scope: Urban

Healthcare setting: Postnatal wards

Mental health condition: Postnatal depression

Population: Mothers at days 2 or 3 post-partum

  • Age: Mothers: > 18 years
  • Gender: Female
  • Socioeconomic background: Half had senior high school qualification, just over half were housewives, more or less equal numbers of high, middle and low social classes
  • Inclusion criteria: 1. > 18 years of age; 2. survival of the infant; 3. at least a junior high school education; and 4. BDI score above the depression cut-off point of 9/10
  • Exclusion criteria: Not specified


InterventionsStated purpose: To investigate the psychosocial effects of a support group programme on postnatally distressed mothers in Taiwan

INTERVENTION:

Name: Support group intervention

Delivered by (NSHW or OPHR and title)

  • Title/name of NSHW/OPHR and number: Registered nurse was the group leader
  • Selection: Not specified
  • Educational background: Trained nurse
  • Training: Not specified
  • Supervision: Not specified
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: Groups met for 4 weekly sessions, each of 1.5-2 hours' duration, held during the day
  • Content of intervention (by types of health worker and per patient/carers: The primary goal of the group was to bring women into contact with other women having similar experiences, so they could share problems and conflicts and talk about solutions. Each week a different topic area was given primary emphasis, although if other issues arose, these were also discussed. If distressed mothers became engaged in another topic that had not been planned, the scheduled topic was deferred for 1 week. The 4 sessions comprised discussions that centred around transition to motherhood, postnatal stress management, communication skills and life planning. Session 1: transition to motherhood; Session 2: postnatal stress management; Session 3: communication skills; session 4: life planning. A crèche was provided, and drinks and biscuits were offered to help make the sessions as friendly and relaxed as possible. There were no fees for attending these support group meetings


CONTROL: Usual care: the control group did not receive a support group intervention (58 women)

CO-INTERVENTIONS: None


OutcomesPatient: Taiwanese BDI*; Taiwanese Perceived Stress Scale §; Taiwanese Interpersonal Support Evaluation List short form § (to assess the availability of support along 4 dimensions: tangible aid, appraisal, self esteem and belonging); Coopersmith's SEI § (to measure evaluative attitudes toward the self in social, academic, family and personal areas of experience)

Carer: none

Process/health worker outcomes: none

Economic outcomes: none

(*: primary outcomes; §: outcomes that we have not reported in this review)

Time points: baseline; 4 weeks


NotesSource of funding: National Science Council, Taipei, Taiwan

Notes on validation of instruments (screening and outcomes): Yes all valid in Taiwanese settings

Additional information (e.g. provide by authors, existence of a published study protocol): None

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: None


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The women who met the inclusion criteria were randomly assigned to either the support or control groups"

Comment: Not mentioned about sequence generation

Allocation concealment (selection bias)Unclear riskComment: Not mentioned

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Not blinded but unlikely to affect the outcome

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
High riskComment: All outcomes self reported

Baseline outcome measurements similarLow riskComment: Baseline characteristics similar

Baseline characteristics similar?Low riskQuote: "There were no significant differences in the demographic characteristics of the experimental and control groups"

Incomplete outcome data (attrition bias)
Efficacy data
High riskComment: Many people did not consent to participate (consent was done after randomisation) so high dropout rate after randomisation

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No adverse outcomes mentioned

Protection against contaminationUnclear riskComment: Women from 2 postnatal wards. It is possible that the control and intervention groups would have had exposure to each other (e.g. if they had peer meetings, etc.)

Reliable primary outcome measuresLow riskComment: All tools validated

Selective reporting (reporting bias)Unclear riskComment: No access to protocol

Other biasLow riskComment: None detected

Dias 2008 RCT India

MethodsStudy design: RCT

Duration of study: Unknown


ParticipantsCountry: India

Income classification: Lower middle

Geographical scope: Taluka semi-urban

Healthcare setting: Home-based care

Mental health condition: Dementia

Population: Patient and carer dyads

  • Age: Carers around 53 years; patients with dementia around 78 years
  • Gender: Both
  • Socioeconomic background: 40% of patients with dementia and 20% of carers had below primary education. Most (90%) unable to afford paid help
  • Inclusion criteria: Using Clinical Dementia Rating scale: mild to moderate dementia; carers: identified person by the family
  • Exclusion criteria: Clinical Dementia Rating scale: severe dementia or severe co-morbid physical health condition


InterventionsStated purpose: Testing the effectiveness of the 10/66 intervention in reducing carer burden, promoting carer mental health and reducing behaviour problems in elderly people with dementia

INTERVENTION:

Name: 10/66 Flexible stepped-care brief carer intervention

Delivered by:

  • Title/name of NSHW/OPHR and number: 4 HCAs (2 in each taluks) and 1 LHC (shared by both taluks)
  • Selection: HCA: knowledge of local language, being literate, motivated to involve in community care of older people. LC: She was part of the intervention team/authors; member of the Dementia Society in Goa
  • Educational background: HCA: passed higher secondary school, LC: not specified
  • Training: HCA: intensive training module over 1 week developed/adapted to local settings. Trained in key skills including listening and counselling skills, bereavement counselling, stress management and health advice for common health problems. Trained by author (geriatrician/epidemiologist) and LHC. LHC: not specified
  • Supervision: for HCA: meetings every 2 weeks with psychiatrist and LC. The HCA would meet the psychiatrist twice a month to give update on person with dementia, especially if they were taking medication. In addition, met with the LC every 2 weeks to share experiences, support one another and problem solve difficult situations. LC: supervised by the psychiatrists
  • Incentives/remuneration: LC: Rs 5000/month. HCA: not specified; psychiatrist remunerated Rs 3000/month for monitoring/supervising LCs


Intervention details:

  • Duration/frequency: Home visits at least every 2 weeks for 6 months
  • Content of intervention (by types of health worker and per patient/carers: HCAs: Intervention for carers: psychoeducation plus follow-up and some counselling skills. Patients or carers (or both) had follow-up with the psychiatrist and patients may be prescribed medication


CONTROL: Control arm dyads received only education and information regarding dementia and were then placed on a waiting list to receive the intervention after 6 months

CO-INTERVENTIONS: Both intervention and control were free to utilise existing health services during this time


OutcomesPatient: Severity of behavioural problems (NPI-S); functional ability of the subject (Everyday Abilities Scales for India)

Carer: Carer mental health (GHQ score)*; carer perceived burden (ZBS); carer distress due to problem behaviours (NPI-D)

Process/health worker outcomes: Process indicators: mean number of visits by HCA, visits by psychiatrists, use of medication not reported

Economic outcomes: Protocol mentions primary outcome: cost of illness but not reported

(*: primary outcomes of study)

Time points: 3 and 6 months after baseline


NotesSource of funding: WHO

Notes on validation of instruments (screening and outcomes): All were validated (Dias 2004)

Additional information: Authors provided supplementary information on supervision, remuneration and other elements. We had access to the study protocol

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: NCT00479271


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Randomization of dyads comprising the person with dementia and their principal caregiver was carried out by an independent person, based on simple random number tables, either to the intervention or waiting list group"

Comment: It was carried out using simple random number tables

Allocation concealment (selection bias)Low riskComment: The allocation was done by an 'independent person'

Blinding of participants and personnel (performance bias)
All outcomes
Low riskPatients and carers recommended by the family and personnel knew who was allocated to the intervention. The personnel did not take part in the measuring the outcome so it does not affect the outcome

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: Mortality is an objective outcome and was reported completely. Agree with low risk assessment

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote: "Outcome evaluations were carried out by researchers who were masked to the allocation status until the end of the project. We attempted to blind outcome evaluations by ensuring that allocation status was kept in a separate office from the outcome evaluation teams. We had also instructed the families not to divulge information on the visits by the Home Care Advisor. However, we anticipated that some unmasking would occur because both the intervention and outcome evaluations were home-based. In order to evaluate the masking process, researchers were asked to guess the intervention status. Another limitation in trials of this nature is that the researchers did, during the course of their outcome evaluation, correctly guess the allocation status in nearly two-thirds of individuals because of the information on health care use which typically led some care-givers to share contacts with the intervention team"

Comment: Authors have mentioned the possibility of unmasking and measure they took to minimise this

Baseline outcome measurements similarLow riskComment: There were differences in outcome measures at baseline: mean GHQ scores was different - higher in the intervention group (Table 2). This difference was adjusted for in subsequent analyses

Baseline characteristics similar?Low riskComment: There were no baseline differences in SES and psychiatric co-morbidity. Outcome measures at baseline were also similar

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: There was > 20% dropout rate (only 59 remain at follow-up compared with 81 randomised) but this was a small sample size. The most common causes of death were stroke (4 people), pneumonia (4 people), myocardial infarction (3 people) and septicaemia (2 people). 2 families moved out of the study area and 2 refused to continue with the trial. However, there was no significant difference in the baseline characteristics of those who died or were alive to the end of the trial (P value = 0.05 for GHQ, NPI-S, NPI-D, Everyday Abilities Scales for India and ZBS scores)

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: The deaths were reported but the intervention adverse effects on the carers not specified

Protection against contaminationUnclear riskComment: There was insufficient information about how close the intervention group and control group were placed (e.g. where they in same village or necessarily mean to share the details of dementia care in Goa (cultural view) - (contacted author for this) 

Reliable primary outcome measuresHigh riskQuote: "Limitation in trials of this nature is that the researchers did, during the course of their outcome evaluation, correctly guess the allocation status in nearly two-thirds of individuals because of the information on health care use which typically led some care-givers to share contacts with the intervention team"

Comment: This may have led to the researchers being biased in the analysis of the outcomes

Selective reporting (reporting bias)High riskComment: They have not reported the cost of illness or process indicators: mean number of visits by home care advisor, visits by psychiatrists, use of medication. The protocol mentions primary outcomes as being: 1. carer mental health, 2. carer burden, 3. behaviour problems and activities of daily living in elderly people with dementia, 4. costs of illness but in the results section the last point is not reported 

Other biasLow riskComment: None detected

Dybdahl 2001 RCT Bosnia

MethodsStudy design: Randomised, 2-sided, parallel group, open-label, assessor-blinded, controlled, trial (unit of randomisation: mother-child dyads; unit of analysis: individuals)

Duration of study: 1995-1996


ParticipantsCountry: Bosnia

Income classification: Middle income

Geographical scope: Urban (town of Tuzla, multiethnic industrial town in north eastern Bosnia)

Healthcare setting: Home (1 refugee settlement, and private accommodation for refugees)

Mental health condition: Child mental health (PTSD, mental health, behavioural problems, scholastic difficulties)

Population: Mother-child dyads (internally displaced refugees)

  • Age: Mothers: mean 30.7 years (SD 4.9), range 20-44 years; children: mean age 5.5 years (SD 0.7)
  • Gender: Both (children 48 girls, 39 boys)
  • Socioeconomic background: Mothers: 85% urban origin, education 14% illiterate (mean 5.3 years, SD 2.8; range 0-14 years), married 63%, widowed 36%, divorced 1%, living in private accommodation 60%, refugee camp 40%
  • Inclusion criteria: Internally displaced Bosnian mothers with a child aged 5-6 years
  • Exclusion criteria: Not participating in any other intervention programme; unlikely to move out of the area before November 1996


InterventionsStated purpose: To provide early childhood care and education and as well as psychosocial support to traumatised children by working with their mothers to help them resolve grief and improve parenting and providing a well-functioning family environment, utilising non-medical professionals in a post-conflict situation

INTERVENTION:

Name: Psychosocial intervention (+ basic medical care), 42 people

Delivered by: OPHR

  • Title/name of NSHW/OPHR and number: Group leaders; 5 preschool teachers trained for the study
  • Selection: Not specified in this report
  • Educational background: As above
  • Training (contents, duration and by whom): In a group of 3-8 group leaders by a mental health professional. Duration: 5-day workshop. Before arrival, the participants received basic information about the programme, its background and aims. Content: participants introduced to one another, receive written material, introductory training in some of the key issues, such as trauma, child development and the importance of interaction and communication (mother-child) two 3-hour seminars. Then 3 days of more detailed description of the programme and reinforcing through group work, demonstrations, role-plays and discussion the above topics (roles of caretaker, trauma and its effects on adults and children, groups and group dynamics, supervision, logbook)
  • Supervision: Weekly group meetings (with 6-8 group leaders with a supervisor (a mental health professional) (and later twice a month)
  • Incentives/remuneration: As above


Intervention details:

  • Duration/frequency: Group leader met weekly with 2 groups of mothers (5 per group) for 5 months; 1 additional visit to each mother at her home at start of programme
  • Content of intervention: Group work using a manual-based approach derived from therapeutic discussions with war-traumatised women at the Psychological Centre in Tuzla (1993-1996), and the ICDP; semi-structured group discussions introduced by group leaders dedicated to providing information about trauma and trauma reactions in adults and children, as well as suggestions for how to meet common post-traumatic needs and problems, with an emphasis on strengthening participants' own coping strategies, and reinforcing existing normal basic communication and interaction skills. Direct attention was given to the mothers and their mental health, to their beliefs and knowledge about children, and the reactions and needs of adults and children following traumatic events


CONTROL: Non-intervention group; participated in evaluations and received free basic medical care (45 people)

CO-INTERVENTIONS: Free basic medical care by local physicians provided for both groups; vitamins or iron were given to 52 children (66% in intervention group; 81% in control group)


OutcomesChildren: IES; description of child (rated by mothers; 11 characteristics, 7-point differential); Mother's rating of children's problems §; (10 problems; 4-point scale; total 30 points); Mother's rating of concentration problems § (yes/no); Raven's Coloured Progressive Matrices §; Children's interview (modified Birleson Depressive Inventory; modified by removing 2 of 13 items; scored 0-32; 11 used as cut-off for depression); well-being §; Psychologists' observations § (video-rated; 14 items; 4-point scale; scored on 2 factors- problems 0-32; resources 0-16); Anthropometrics: haemoglobin §

Mothers: Perceived Social Support; IES; well-being §

Process/health worker outcomes: Not reported

Economic outcomes: Not reported

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Outcomes not used in quantitative synthesis: War Trauma Questionnaire (given at baseline)

Time points: Baseline, 5-6 months after recruitment


NotesSource of funding: UNICEF; University of Tromso

Notes on validation of instruments (screening and outcomes): Mother's rating of child's concentration and concentration problems; perceived social support - not validated separately. IES scores: not diagnostic of PTSD but some literature suggests IES score above 33 suggestive of PTSD

Additional information: Group work described in Dybdahl 1996; Dybdahl 1999

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Not registered


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote from report: "The assignment was random. All the names of the mother–child dyads were written on pieces of paper, which were folded, mixed together, and then separated into two piles at random so that one pile formed the intervention group and the other pile formed the control group"

Allocation concealment (selection bias)Unclear riskComment: Not stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: Participants and intervention personnel were not blinded to allocation

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: Physical and psychosocial outcomes were conducted by teams of physicians and experienced health workers assistants not involved in delivering interventions and blind to interventions

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskComment: Physical and psychosocial outcomes were conducted by teams of physicians and experienced health workers assistants not involved in delivering interventions and blind to interventions

Baseline outcome measurements similarLow riskComment: Baseline imbalances in prognostic variables noted for psychosocial support for mothers and well-being (but not statistically significant); and children's haemoglobin (P value = 0.3); however, analyses were for differences in groups for changes from baseline

Baseline characteristics similar?Unclear riskComment: Mothers in refugee camps reported more war trauma and were more likely to be widowed during the conflict

Incomplete outcome data (attrition bias)
Efficacy data
High riskQuote: "Twelve of the families dropped out of the study and did not participate in scheduled interventions: 7 from the intervention group, and 5 from the control group. Several of the mothers and children did not complete all tests at both test periods for a variety of reasons; thus the number of participants varied from test to test"

Comment: Denominators not provided by intervention or control for each of the tests

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No safety data provided; it was assumed that intervention group results would be better than control group a priori

Protection against contaminationUnclear riskComment: Mothers in refugee camps could have discussed contents of the intervention and supported mothers in control group

Reliable primary outcome measuresHigh riskComment: Many outcome measures used were not previously validated; some had poor psychometric properties (BDI)

Selective reporting (reporting bias)Low riskComment: Protocol not available but all measures stated in methods were reported

Other biasHigh riskComment: Multiple statistical analyses used without pre-specified primary or secondary outcomes; analyses corrected for multiple comparisons yielded non-significant results

Ertl 2011 RCT Uganda

MethodsStudy design: RCT

Duration of study: Trial conducted between November 2007 and October 2009 (last follow-up). Preceded/overlapped by an epidemiological survey July 2007 to April 2008


ParticipantsCountry: Uganda

Income classification: Low income

Geographical scope: Rural and urban, takes place in IDP camps and new settlement areas in 3 regions of Northern Uganda: Anaka: rural area with the most documented rebel activity, Awer: urban relatively safe area close to large town called Gulu, Padibe: rural (long distance from Gulu and was more affected by the war)

Healthcare setting: Home

Mental health condition: Child mental disorder, PTSD

Population: Patient, children/adolescents (child soldiers)

  • Age: 12-25 years; mean age 18.66 years (SD 3.77)
  • Gender: Both
  • Socioeconomic background: Former child soldiers, mean economic status in Euros (as measured by household possessions weighted by current local market prices divided by household size): EUR44-55
  • Inclusion criteria: Clinical diagnosis of PTSD derived from expert interviews, member of the group of formerly abducted people or former child soldiers. To keep the trial naturalistic we did not exclude patients with suicidal ideation, substance abuse, or depression
  • Exclusion criteria: Current substance dependence, mental retardation, psychotic disorder


InterventionsStated purpose: Aim of this study was to examine whether individual-based, trauma-focused NET is feasible and effective in reducing PTSD symptoms in traumatised former child soldiers living in the IDP camps of Northern Uganda when carried out by trained local lay therapists directly in the communities

INTERVENTION 1:

Name: NET

Delivered by:

  • Title/name of NSHW/OPHR and number: Local lay counsellors, 14 (7 women and 7 men)
  • Selection: Not specified
  • Educational background: Not specified
  • Training: Training in and performance of NET were as outlined by an adapted field version of the manual, duration and trainers: unspecified
  • Supervision: "Treatment fidelity and therapeutic competence were monitored by case discussions in supervision meetings, observation and evaluation of treatment sessions via video recordings, and review of the obligatory treatment process notes for each session. In the case of NET, testimonies were additionally reviewed to check for trauma focus and richness of detail", not specified by whom
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: 8 sessions of individual therapy, "Sessions lasted between 90 and 120 minutes and were scheduled 3 times a week"
  • Content of intervention: "We chose an individual-based over a group-based treatment, because we expected this approach to better meet the requirements of former child soldiers, who present with high levels of PTSD as well as mistrust." "Narrative exposure therapy is a short-term, trauma-focused treatment developed for use in low-resource countries affected by crises and conflict. Intended for survivors of multiple trauma, this therapy results in the detailed documentation of the patients' lives as part of the therapy process." "Irrespective of treatment condition, the first session included psychoeducation on PTSD, its symptoms and consequences for the individual, and explanation of the rationale for narrative exposure therapy or academic catch-up". Participant constructs chronological account of self biography with therapist, reconstruct fragmented memories of traumatic events and to habituate


INTERVENTION 2:

Name: Academic catch-up training

Delivered by

  • Title/name of NSHW/OPHR and number: Local lay counsellors, 14 (7 women and 7 men)
  • Selection: Not specified by whom
  • Educational background: Not specified by whom
  • Training: Written guidelines that summarised basic counselling skills and session outlines for the academic catch-up training, duration and trainers unspecified
  • Supervision: "Treatment fidelity and therapeutic competence were monitored by case discussions in supervision meetings, observation and evaluation of treatment sessions via video recordings, and review of the obligatory treatment process notes for each session". Not specified by whom
  • Incentives/remuneration: Not specified by whom


Intervention details:

  • Duration/frequency: 8 sessions of individual therapy, "Sessions lasted between 90 and 120 minutes and were scheduled 3 times a week"
  • Content of intervention: "Carried out according to written guidelines that summarized basic counselling skills and session outlines for the academic catch-up training". "Irrespective of treatment condition, the first session included psychoeducation on PTSD, its symptoms and consequences for the individual, and explanation of the rationale for narrative exposure therapy or academic catch-up". "An intensive English catch-up course using the official Ugandan schoolbooks for different skill levels was developed. The evaluation of process notes revealed that the counsellors spent 55% of the total time allocated for academic catch-up doing academic training. The rest of the time was equally dedicated to psychoeducation, conducting discussions on coping with symptoms, and dealing with current problems. None of the counsellors deviated from the restriction that they should not focus on traumatic experiences in this condition. In the last session, the participants received the English textbooks and exercise books they had been working on with their counsellors"


CONTROL: Wait-list control, 10 received suicide intervention due to suicidal ideation. "After the 12-month follow-up, each waiting-list and academic catch-up participant still presenting with PTSD was offered narrative exposure therapy"

CO-INTERVENTIONS: Wait list had suicide intervention for those who exhibited high levels of suicide ideation (10 people)


OutcomesPatient: PTSD symptom load* (Clinician-Administered PTSD scale; CAPS), functional impairment *(CAPS); guilt § (CAPS), symptoms of depression (MINI Neuropsychiatric Interview for depression module A; MINI), suicidal ideation (MINI), stigmatisation § (Perceived Stigmatization Questionnaire; PSQ)

Carer: n/a

Process/health worker outcomes: "Treatment fidelity and therapeutic competence were monitored by case discussions in supervision meetings, observation and evaluation of treatment sessions via video recordings, and review of the obligatory treatment process notes for each session. In the case of narrative exposure therapy, testimonies were additionally reviewed to check for trauma focus and richness of detail. No deviations from the study protocol were noted", none reported in study §

Economic outcomes: None

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: Baseline, 3-, 6-, and 12-month follow-up


NotesSource of funding: This study was supported by the NGO vivo and by funding from the DFG (Deutsche Forschungsgemeinschaft) and the Ein Herz für Kinder foundation

Notes on validation of instruments (screening and outcomes): CAPS and MINI validated, PSQ not validated

Additional information: clinicaltrialsgov/show/NCT00552006

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: NCT00552006


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: Randomly selected but does not specify as to how

Allocation concealment (selection bias)Unclear riskComment: Unspecified

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: Unspecified

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote: "Pretreatment assessments as well as follow-up assessments at 3 months, 6 months, and 12 months after treatment were conducted by 13 clinical psychologists blinded to treatment conditions"

Baseline outcome measurements similarLow riskComment: No statistical differences

Quote: "There were no systematic pretreatment differences in sociodemographic data, traumatic load, and psychological impairment between the 3 groups"

Baseline characteristics similar?Low riskComment: No statistical differences

Quote: "There were no systematic pretreatment differences in sociodemographic data, traumatic load, and psychological impairment between the 3 groups"

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: 3-month follow-up: 26 included and 2 discontinued in NET, 24 included, 2 discontinued and 1 died in academic catch-up (ACU) at 6 months' follow-up: 26 included in NET, 23 included, 1 not found in ACU at 12 months' follow-up: 25 included 1 loss to follow-up in NET, 23 in NET. All 28 wait-list participants remained throughout treatment

Quote: "Apart from providing participants with the written documentation of their lives or with the English textbooks and exercise books, no incentives were offered. During follow-up periods, individuals who had relocated far from the former IDP camps were refunded travel expenses"

Comment: This would have reduced attrition. Unlikely to have affected outcomes

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskComment: No negative effects of NET were observed in this trial. Clinically reliable aggravation of symptoms was not present in the NET group but was present in 4.4% of the academic catch-up and 10.7% of the waiting-list participants

Protection against contaminationLow riskComment: Lay counsellors were instructed not to integrate treatment material from NET to ACU

Reliable primary outcome measuresUnclear riskQuote: "Further, the trial might have been underpowered to detect significant treatment effects for most of the secondary outcome variables"

Comment: In addition, have little information on validity of these instruments in the context of the trial

Selective reporting (reporting bias)Low riskComment: All pre-specified outcomes in protocol reported

Other biasLow riskComment: None detected

Fritsch 2007 RCT Chile

MethodsStudy design: RCT

Duration of study: 6 months


ParticipantsCountry: Chile

Income classification: Upper middle income

Geographical scope: Urban (Santiago)

Healthcare setting: 5 PHC clinics

Mental health condition: Major depression

Population:

  • Age: 18-70 years
  • Gender: Female
  • Socioeconomic background: About 30% employed, 8% unemployed, 5% student
  • Inclusion criteria: As above, with depression for 3 months (screening with GHQ-12 ( ≥ 5) twice, 2 weeks apart), and at least 1 child aged 6-16 living with her
  • Exclusion criteria: Abuse/dependence on alcohol or drugs, bipolar disorder, psychotic symptoms (present or past), suicidal ideation, pregnancy, physical or mental disabilities that would hamper their participation in the study


InterventionsStated purpose: To compare a monitored pharmacotherapy intervention with current treatment in PC

INTERVENTION:

Name: Monitored pharmacotherapy

Delivered by

  • Title/name of NSHW/OPHR and number: 5 generalist doctors/GP (1 per practice) and non-professional trained staff from the 5 clinics
  • Selection: Based on practice selection
  • Educational background: Qualified doctors
  • Training: For doctors: 6 hours of training by the principal investigators; for non-professional trained staff: 2 hours
  • Supervision: Doctors had permanent monitoring by the principal investigators. In addition, doctors participated in monthly meetings with a psychiatrist to discuss cases
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: Regular visits to GP by patients
  • Content of intervention: Regular visits to the GP with pharmacotherapy structured using clinical algorithms (use of available antidepressants: fluoxetine, amitriptyline, imipramine). Regular telephone contact by non-professional but trained personnel who did education, monitoring of drug intake and side effects and to remind/reinforce the need for regular follow-up with the doctor


CONTROL: Usual care: based on the Ministry of Health's programme for treatment of depression in PC: consultations with GPs, pharmacotherapy, individual or group psychotherapy with psychologists, and referral to psychiatrists

CO-INTERVENTIONS: None


OutcomesPatient: Diagnosis of depression (MINI), severity of symptoms (HDRS), QoL (SF-36)

Carer: None

Process/health worker outcomes: None

Economic outcomes: None

Time points: 3 and 6 months


NotesSource of funding: Fondecyt, Chile

Notes on validation of instruments: All instruments validated internationally and in Chilean setting

Additional information: No protocol

Handling the data: As per footnotes in data and analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComment: Patients were assigned randomly. This took place at the individual level, using computer systems managed from a central level

Allocation concealment (selection bias)Low riskComment: Patients were assigned randomly. This took place at the individual level, using computer systems managed from a central level

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Due to the nature of the intervention, the participants could not be blinded to the intervention and this is unlikely to create any bias to the results

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: There were no objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskComment: Assessors were not involved in the design of the study, did not know the study hypotheses, and were blinded to group assignment

Baseline outcome measurements similarLow riskComment: The 2 study groups did not vary significantly

Baseline characteristics similar?Low riskComment: The 2 study groups did not vary significantly

Incomplete outcome data (attrition bias)
Efficacy data
Unclear riskComment: The MINI scores are not reported at follow-up. In addition, the author does not show the comparative tables of the results at 3 and 6 months (only individual figures per allocated group but no summary statistics)

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
High riskComment: We have incomplete information

Protection against contaminationUnclear riskComment: We have incomplete information and we are not sure if the GPs in this setting may be doing both intervention and control interventions

Reliable primary outcome measuresLow riskComment: These tools are known to be validated from previous studies

Selective reporting (reporting bias)Low riskComment: No selective reporting, though some reporting of things that would be useful not done like costs of psychiatric drugs

Other biasLow riskComment: No other sources of bias

Gavrilova 2009 RCT Russia

MethodsStudy design: Randomised, parallel group, single-blind, controlled, clinical trial

Duration of study: 2000-2004


ParticipantsCountry: Russia

Income classification: Middle

Geographical scope: Urban (Moscow - South administrative district, patients registered in 3 general practices)

Healthcare setting: Group community training

Mental health condition: Dementia

Population: Patient-carer dyad

  • Age: Patients: > 65 years; carers' mean age 61.5 years (SD 17.6)
  • Gender: Both
  • Socioeconomic background: Not specified
  • Inclusion criteria: Patients > 65 years; met DSM-IV criteria for dementia
  • Exclusion criteria: Serious current physical illness, no family carer, > 1 person with dementia in same household


InterventionsStated purpose: To test the effectiveness of the 10/66 Dementia Research Group brief carer intervention among people with dementia and their carers

INTERVENTION:

Name: 10/66 brief carer intervention

Delivered by:

  • Title/name of NSHW/OPHR: Newly qualified doctors (number not specified)
  • Selection: Not specified
  • Educational background: Medical degree
  • Training (contents, duration and by whom): 2-day training, using the 10/66 intervention manual (includes vignettes, role plays, live interviews).
  • Supervision: Not specified.
  • Incentives/remuneration: Not specified.


Intervention details:

  • Duration/frequency: 5 weekly 30-minute sessions
  • Content of intervention: Intervention for carers. Content (manualised approach): 3 modules: assessment of cognitive and functional impairment, carers' knowledge and understanding, care arrangements (1 session), basic education about dementia illness, what to expect in future, local available resources (2 sessions), training regarding dealing with specific problem behaviours (2 sessions)


CONTROL: Usual medical care (on a wait-list for the intervention)

CO-INTERVENTIONS: Medical care for both intervention and control


OutcomesPatient: Behavioural and psychological symptoms of dementia (NPI-Q); DEMQOL

Carer: ZBI; SRQ-20 - carer mental health; caregiver QoL (WHOQOL-BREF)

Process/health worker outcomes: Not assessed

Economic outcomes: Not reported

Time points: Baseline, 6 months

No mention of study's primary or secondary outcomes


NotesSource of funding: WHO

Notes on validation of instruments (screening and outcomes): Validated

Additional information (e.g. provide by authors, existence of a published study protocol): None

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: ISRCTN41039907


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote from report: "Randomisation was carried out in London, with the codes transmitted immediately back to the Moscow centre by e-mail. We used a stratified permuted block method to ensure as fare as possible an even distribution of baseline caregiver strain assessed using the Zarit Burden Interview"

Comment: Central randomisation apparently computer generated

Allocation concealment (selection bias)Unclear riskComment: Not reported

Comment: Even though sequence generation was centrally done, it was unclear how allocation was concealed

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: The control group was a wait-list so differential interventions were unlikely

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes used

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskComment: This was an open-label trial; however, the assessors were blind to treatment allocation

Baseline outcome measurements similarLow riskComment: All similar

Baseline characteristics similar?Low riskComment: All similar. There were baseline imbalances in the degree of care needed by the patients in control group. However, this was adjusted in statistical analysis

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: Attition was low in both groups (only deaths) and adjusted for in statistical analysis

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No safety outcomes reported

Protection against contaminationLow riskComment: Wait-list control so unlikely to be contamination

Reliable primary outcome measuresUnclear riskComment: All outcome measures were validated. We do not know if tools were translated/methods used

Selective reporting (reporting bias)Low riskComment: Trial prospectively registered. All pre-stated outcomes reported

Other biasLow riskComment: None detected

Gordon 2008 RCT Kosovo

MethodsStudy design: RCT

Duration of study: September 2004 to May 2005


ParticipantsCountry: Kosovo

Income classification: Lower-middle

Geographical scope: Rural, Suhareka region, a fertile agricultural area in the southern part if of Kosovo

Healthcare setting: Small group school setting-high school

Mental health condition: PTSD

Population: Patient (adolescents only)

  • Age: 14-18 years; mean age 16.3 years
  • Gender: Both, significantly more girls than boys
  • Socioeconomic background: War-traumatised area with students who had lost both or 1 parent and 90% of the homes of that area were destroyed
  • Inclusion criteria: Students having PTSD as defined according to a scoring algorithm of the HTQ previously described by the Harvard Refugee Trauma group and used in a Kosovar Albanian population. This definition of PTSD requires a score of 3 or 4, on a Likert scale of 1-4, on at least 1 of the 4 of the re-experiencing symptoms (Criterion B), at least 3 of the 7 avoidance and numbing symptoms (Criterion C), and at least 2 of the 5 arousal symptoms (Criterion D) in addition to exposure to a traumatic event (Criterion A)
  • Exclusion criteria: No specific exclusion criteria. Students having PTSD symptoms as defined above may participate in the study


InterventionsStated purpose: To determine whether participation in a mind-body skills group programme based on psychological self care, mind-body techniques and self expression decreases symptoms of PTSD

INTERVENTION 1:

Name: Mind-body school-based skill group

Delivered by:

  • Title/name of NSHW/OPHR and number: 4 high-school teachers
  • Selection: Information from author: "The teachers were self-selected"
  • Educational background: Information from author: "All graduated from the university but did not have advanced degrees. They would have whatever certification is required to teach high school in Kosovo"
  • Training: 2 part, 10-day intensive training undertaken in 1999-2000; Washington DC-based faculty of the centre for Mind-body medicine (CMBM). Info from author: "When we went to Kosovo after the war to train health professionals, the teachers from this village came to our training and brought the mind-body techniques back to their school in the rural village and began using them with their students. We did one pilot study before we did the RCT"
  • Supervision: CMBM's Kosovo faculty of psychiatrist and psychologist
  • Incentives/remuneration: Information from author: "they were paid a small stipend"


Intervention details:

  • Duration/frequency: 12 sessions for 2 hours twice a week for 6 weeks
  • Content of intervention: Self expression and personal sharing with instruction in and use of meditative and imaginative mind body techniques; given in small group sessions (about 10 students per group) Format is now manualised. The aim is not to discuss traumatic events but create a supportive environment in which self awareness, sharing and listening are encouraged, teach them self care techniques, and give them skills to deal with traumatic events in their daily life, and to understand the trauma they suffered


CONTROL: Wait-list control group, who received the 12 session mind-body skills after the first intervention group finished their 12 sessions

CO-INTERVENTIONS: None


OutcomesPatient: HTQ

Carer: n/a

Process/health worker outcomes: None

Economic outcomes: None reported

Time points: Baseline (pre-intervention), immediately post-intervention (i.e. after 6 weeks), 3-month follow-up after the intervention


NotesSource of funding: The Center for Mind-Body Medicine listed as sponsor on protocol

Notes on validation of instruments (screening and outcomes): Used previously in Kosovo as described in Lopes Cardozo 2000

Additional information: clinicaltrials.gov/ct2/show/NCT00136357?term=NCT00136357

Handling the data (e.g. imputed values/other calculations we have made): None

Prospective trial registration number: NCT00136357


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Students were stratified according to gender and randomly assigned by the research director using random numbers generated by Microsoft Excel 2003"

Allocation concealment (selection bias)High riskQuote: "The list of assigned groups was given to the teachers, who then notified the students of their group assignment"

Comment: No allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Not blinded but unlikely to affect the outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Unclear riskQuote: "While it is possible that students wanted to please the teachers by reporting a decrease in symptomatology after the groups, the teachers' experience, and that of the observers was that greater familiarity with the teachers, on the contrary, facilitated more frank discussions and sharing of problems and symptoms after as well as before and during the intervention"

Comment: Teachers both performed intervention and delivered the instruments but given explanation above, may be classified as unclear risk

Baseline outcome measurements similarLow riskComment: All similar

Baseline characteristics similar?Low riskInformation from author: Age, sex and baseline PTSD were all similar

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: Low dropout rate

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskInformation from author: "We did not look at any adverse outcomes. The teachers received ongoing supervision. The supervisors and teachers would have notified us if any adverse events occurred as required by the IRB, but there were none. We did not formally record this"

Comment: Low risk

Protection against contaminationUnclear riskComment: Just 1 school in the study, so may have been contamination. However, control group received intervention as soon as intervention group had finished. Some of the results (e.g. arousal) suggest improvement in control group before they received intervention which may suggest contamination

Reliable primary outcome measuresLow riskQuote: "The study's main limitation was the lack of inclusion of a trauma exposure scale in the actual interviews with participants. This was done deliberately, so as not to obligate the students to discuss the traumatic events they had experienced". Due to the pervasive violence and universal homes' destruction it was assumed all students had traumatic exposure to events

Comment: However, scale used for PTSD is reliable and validated. Consider this to be low risk

Selective reporting (reporting bias)Low riskComment: Only 1 outcome on the protocol, HTQ

Other biasLow riskComment: None detected

Hirani 2010 CRCT Pakistan

MethodsStudy design: Cluster RCT (unit of allocation: residents with similar SES, ethnicity, education and income level. Unit of randomisation: individual)

Duration of study: 2000-2004


ParticipantsCountry: Pakistan

Income classification: Low income

Geographical scope: Urban (inner city slum area of Karachi (Pakistan) a sprawling metropolis of 18 million residents located in Arabian sea)

Healthcare setting: Adult literacy centres (ACLs)

Mental health condition: Depression

Population: Women. The community was selected for ESB intervention testing due to the availability of nearby factories and employment opportunities for women following the ESB

  • Age: 25-35 years
  • Gender: Female
  • Socioeconomic background: Economically disadvantaged women. Most women reported < 4 years of formal education and most women were not employed. Household size was 6-10 people for most women and monthly household income averaged USD55.00 US
  • Inclusion criteria: Women in adult literacy programmes in each of the randomly chosen clusters were recruited into the study and 25-35 years
  • Exclusion criteria: Not specified


InterventionsStated purpose: To provide an evidence-based intervention to address the PHC problems confronting women in Pakistan and worldwide: depression and violence. Specifically, we tested the differential effectiveness of a community-derived intervention of ESB, developed through community-based participatory methods against an evidence-based empirically tested counselling model

INTERVENTION 1:

Name: ESB intervention

Delivered by:

  • Title/name of NSHW/OPHR: CHWs
  • Selection: Not specified
  • Educational background: Not specified
  • Training (contents, duration and by whom): 21 hours training, included skill-building on components of the intervention as well as research ethics of privacy and confidentiality
  • Supervision: Not specified
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: 8 weekly at the adult literacy centres (for both Intervention 1 and 2)
  • Content of intervention (by types of health worker and per patient/carers: Skills for employment attainment and retention such as, effective communication, balancing personal and work life and time management, conflict resolution, dealing with abuse and harassment, enhancing self efficacy, effective parenting, and personal hygiene and grooming


INTERVENTION 2:

Name: Group counselling intervention

Delivered by:

  • Title/name of NSHW/OPHR: CHWs
  • Selection: Not specified
  • Educational background: Not specified
  • Training (contents, duration and by whom): 21 hours of training; included skill-building on components of the intervention as well as research ethics of privacy and confidentiality
  • Supervision: Not specified
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: 8 weekly at the adult literacy centres (for both Intervention 1 and 2)
  • Content of intervention(by types of health worker and per patient/carers: Covered effective communication, balancing personal and work life and time management, conflict resolution, dealing with abuse and harassment, enhancing self efficacy, effective parenting and personal hygiene and grooming


CONTROL: Usual care (the control group received no intervention)

CO-INTERVENTIONS: None


OutcomesPatient: Depression (BDI-II, IPV § (questionnaire - instrument developed by WHO guidelines and modified based on the Pakistani national gender indicators list for violence again women and self efficacy § (GSE Scale; employment status §

Carer: Not applicable

Process/health worker outcomes: Not assessed

Economic outcomes (and where these can be found, e.g. ref or table number): Not reported

Time points: Baseline, 8 weeks

No mention of primary or secondary outcomes

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)


NotesSource of funding: Aga Khan University Research Council

Notes on validation of instruments (screening and outcomes): BDI-II, GSE and IPV instruments validated internationally but not mentioned if validated in Pakistani context

Additional information (e.g. provide by authors, existence of a published study protocol): Not specified

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Not specified


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComment: It is cluster sampling

Quote: ''A three-arm randomised controlled trial with cluster randomisation sampling was followed, whereby blocks of similar ethnic, language, and cultural affiliated families were randomised to an intervention". "The methodology of cluster randomisation maintained the internal validity of the research by preventing the contamination of interventions among the study groups." "Since our study was conducted in a densely populated urban community, randomisation at the individual level could result in women randomly assigned to different intervention groups living next door. Therefore, intra-class sampling was followed to maximize homogeneity and decrease the variance in the data. For intra-class sampling, the community was divided into eighteen clusters. Each cluster was defined according to residents with a similar socio-economic status, ethnicity, education, and income level. Three sets of two adjacent similar clusters were randomly assigned to the interventions of economic skill-building, counselling and control group. Each cluster had several hundred adult women. The randomisation took place maintaining the community based participatory approach and the internal validity of the research remained strong"

Allocation concealment (selection bias)Unclear riskComment: No mention of whether the allocation of clusters was concealed

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: No blinding but this is unlikely to affect outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Unclear riskComment: All instruments were self reported (not mentioned if there was an interviewer to administer them), so unlikely that there was any blinding

Baseline outcome measurements similarUnclear riskComment: Unable to say as no baseline data reported

Baseline characteristics similar?Low riskQuote: "No significant differences existed in demographic characteristics between the groups. Most of the women were between 25 and 35 years of age. Most women reported less than 4 years of formal education and most women were not employed. Household size was between 6 and 10 persons for most women and monthly household income averaged $55.00 dollars US"

Comment: However, there is no table of characteristics of participants so unable to make a truly informed comment on this

Incomplete outcome data (attrition bias)
Efficacy data
Unclear riskQuote: "Twenty four women began and completed the first 8-week intervention sessions and outcome measures, specifically 7 women received counselling, 9 women received economic skill- building, and 8 women were in the control group"

Comment: However, no information on dropouts

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No safety outcomes reported. Not sure if they were looked for or not. No protocol available

Protection against contaminationLow riskQuote: "The methodology of cluster randomisation maintained the internal validity of the research by preventing the contamination of interventions among the study groups. However, cluster randomised trials can often prevent contamination between intervention and control groups" and .29-31 Since our study was conducted in a densely populated urban community, randomisation at the individual level could result in women "randomly assigned to different intervention groups living next door. Therefore, intra-class sampling was followed to maximize homogeneity and decrease the variance in the data. For intra-class sampling, the community was divided into eighteen clusters. Each cluster was defined according to residents with a similar socio-economic status, ethnicity, education, and income level. Three sets of two adjacent similar clusters were randomly assigned to the interventions of economic skill-building, counselling and control group. Each cluster had several hundred adult women. The randomisation took place maintaining the community based participatory approach and the internal validity of the research remained strong"

Reliable primary outcome measuresUnclear riskComment: The tools do not seem validated for the setting in which they are used, so difficult to know if they are reliable

Selective reporting (reporting bias)Unclear riskComment: All outcomes reported but need to check with protocol to check if these are also the prespecified outcomes

Other biasLow riskComment: No other bias

Jenkins 2012 C-RCT Kenya

MethodsStudy design: Cluster RCT, allocated by clinic, analysed at individual level for patient outcome, analysed at clinic level for GHQ cases

Duration of study: Conducted in 2010


ParticipantsCountry: Kenya

Income classification: Low income

Geographical scope: Urban and rural; Nyanza province, Kenya, as this was the region where the national training programme 2005/2010 had hither to trained fewest staff, and thus most clinics were eligible for study. The districts of Siaya, Bondo and Rachuonya were selected, allocated around Kisumu near Lake Victoria

Healthcare setting: PC facilities (dispensaries and PHC centres)

Mental health condition: All mental disorders

Population: Patients (adults and children), anyone attending PHC

Age: > 16 years

Gender: Both

Socioeconomic background: Livelihoods were based on subsistence farming, an extensive fishing industry along the lake, and some commercial business. The majority tribe is Luo. The area was the site of significant election violence in January 2007

Inclusion criteria: The sample framework was the Ministry of Health list of all publicly funded primary care facilities in Siaya, Bondo and Rachuonya districts in Nyanza province. The criteria for entry for clinics was that they were in the Ministry of Health list of PHCs, and were publicly funded. Criterion for entry for patients was that they were over 16 years

Exclusion criteria: Centres where staff had previously received training from the KMTC mental health training programme were excluded from the study; publicly funded. Criterion for entry for patients was that they were over 16 years of age; criteria for exclusion were dementia and learning disability of such severity as to be unable to complete the questionnaires; life threatening illness; did not speak the language spoken by the researchers; and refusal to co-operate


InterventionsStated purpose: To conduct a phase 2 exploratory trial as a cluster RCT, testing the effect of a low-cost training intervention, integrated with the national health sector reforms, 1. on the competencies of primary care staff to recognise mental disorders, treat and make appropriate referrals to the scarce specialist services and 2. on recovery (improved health and social outcomes and quality of life) of clients

INTERVENTION:

Name: PC mental health training

Delivered by:

Title/name of NSHW/OPHR and number: PHC staff (all nurses and clinical officers (doctors) eligible for training); 2 in each centre

Selection: Self selection: 2 invited from each centre

Educational background: Nurses and clinical officers at PHC

Training: RJ trained local trainers (3 courses) to deliver the course to frontline workers, in 2005 (By RJ) and gave them a refresher course in 2009 (40 hours in total). The trainers had done the KMTC mental health training and had been delivering training since then. These trainers included 20 senior staff from Kenya medical college (KMTC) (i.e. from Nairobi, provincial medical training colleges and the Ministry of Health rural health training centres). They were supplied with good practice guidelines and handouts to those who attended the training course, and the project also provided a training course on mental health for the local district public health nurses. Course structure: comprehensive structured interactive mental health training programme for 5 days. Curriculum and teaching materials developed by the WHO Collaborating Centre in dialogue with Kenya partners, based on the Kenya adaptation of the WHO primary carePC guidelines. Ccontent: 5 modules: 1. core concepts of MH, MDs, their contribution to physical health economic and social outcomes; 2. core skills (examination, communication, assessment, managing difficult cases/ violence/bad news); 3. neurological disorders (epilepsy, Parkinson's disease, headache, dementia, toxic confusional states), 4. psychiatric disorders (content based on the WHO primary care PC guidelines for mental health, Kenya adaptation); 5. system issues of policy; legislation; links between mental health and child health, reproductive health, HIV and malaria; roles and responsibilities; health management information systems; working with community health worker CHWs and with traditional healers; and integration of mental health into annual operational plans. Use of role plays (25 each), theory, discussion, videos, emphasis on acquisition of practical skills and competencies for assessment, diagnosis and management)

Supervision: No supervision available from district level and poor medication supply

Incentives/remuneration: "Each health facility is staffed by one or more nurses and clinical officers on Ministry of Health salaries, and around 15-20 community health workers are not remunerated by the Ministry by the Ministry  of Health but are now expected to receive small remuneration from the community"

Intervention details:

Duration/frequency: Varying depending on patient

Content of intervention: Diagnosis and treatment with medicines, and follow-up

CONTROL: Usual care, PHCs that had not received prior KMTC training, neither were given training during this intervention

CO-INTERVENTIONS: Patients  in  both  intervention  and  the  control  groups  were  treated  as  the  health  worker  routinely   decided,  based  on  their  knowledge,  experience  and  training


OutcomesPatient: GHQ change in patients (neurotic symptoms, including morbid rating), EQ5D § (health outcome for wide range of health conditions and treatments), WHODAS II (disability according to ICF)

Carer: n/a

Process/health worker outcomes: GHQ identification index of clinics: detection rate of mental disorder (agreement/disagreement  of  staff  diagnosis  with  patient  rated  GHQ  score  cut-off)

Economic outcomes: None reported

Time points: Baseline (3 months post training), 3 months (6 months post training)

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)


NotesSource of funding: Nuffield Foundation and Department for International Development (UK)

Notes on validation of instruments: All instruments available in English and Kiswahili, and all validated in local setting. GHQ: widely validated in Africa; WHODAS II: validated (Ref from WHO, www.who.int/classifications/icf/en/); EUROQOL 5D: "The  special  validated  calculator  used  in  this  project  is  derived  from   normative  data  from  Zimbabwe  for  the  EQ" Global Forum for Health Research (2002) The 10/9 Report on Health Research, 2001-2002. Geneva, Switzerland

Additional information: www.controlled-trials.com/ISRCTN53515024

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: ISRCTN53515024


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote 1: "All public level 2 and 3 health facilities were eligible for randomisation, which was done by DK and the Great Lakes University Knowledge Management and Research Department, using a table of random numbers drawn from JT McLure and F Dietrich 1994, Statistics, Macmillan College Publishing Co. pp 909-911"

Quote 2: "A random sample of 99 centres were selected stratified by health facility level, which were then randomly allocated to intervention and control groups, resulting in 33 dispensaries and 16 health centres in the intervention group and 37 dispensaries and 13 health centres in the control group"

Allocation concealment (selection bias)Low riskInformation from the author: Allocation to intervention and controls was concealed from the research assistants

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The clinic staff were not blind as to whether they had received the training. We did not run a quantitative check on whether recruited clinic clients were aware of the trained status of their health workers"

Comment: However, unlikely to affect outcome. This was performed in real conditions in Kenya

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote: "The research assistants were blind to whether the clinic staff had received the mental health training course, and to whether clients were attending clinics with trained or untrained staff. JA, who organised the research assistants in the field, was not blind to the clinic status"

Baseline outcome measurements similarLow riskComment: All similar

Baseline characteristics similar?Low riskQuote: "The groups were generally similar on these parameters except that intervention clinics had more availability of benzodiazepines, and more clients who were unmarried"

Comment: These were adjusted for in the analysis

Incomplete outcome data (attrition bias)
Efficacy data
Low riskQuote: "To reduce the possibility of attrition bias [31], we paid the 12 participants per cluster £2 per day to complete their initial assessment day (3 months after training of the health workers) and follow up day 12 weeks later, as compensation for their transport costs and time"

Comment: In addition, dropout rate very small (> 90% retention rate)

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskInformation from author: No major adverse events were noted, e.g. suicides. NB The trial was of training, not of a specific medicine or specific intervention

Protection against contaminationLow riskQuote: "Randomisation was conducted at the cluster level, namely PHC level rather than individual health worker level. If randomisation had taken place at individual health worker level, the risk of contamination between the practice of trained and untrained staff would be high, since they work closely in small teams"

Comment: In addition, mentioned that there is other training happening simultaneously (HIV, malaria, nutrition, paediatrics) but none of them covered mental health issues (HIV training was only about pre-post test counselling for HIV)

Reliable primary outcome measuresHigh riskComment: GHQ-12 is a screening instrument and was used here as a diagnostic and symptom severity scorer

Selective reporting (reporting bias)Low riskComment: Outcomes in protocol and in paper are the same

Other biasLow riskComment: The first author confirmed that all results "adjusted for clustering"

Jordans 2010 C-RCT Nepal

MethodsStudy design: Cluster RCT, unit of allocation: schools, unit of analysis: individual

Duration of study: December 2006 to March 2007


ParticipantsCountry: Nepal

Income classification: Low income

Geographical scope: 4 districts of rural south-western Nepal (Banke, Dang, Bardia, Kailali)

Healthcare setting: School

Mental health condition: Psychosocial distress (including PTSD symptoms)

Population: Patient (children/adolescents)

Age: 11-14 years

Gender: Both, more girls in treatment group

Socioeconomic background: Significant differences in groups despite randomisation: more brahmins in treatment group, Terai caste in wait-list (none in intervention group). Higher education among treatment group. Religion and place of residence were statistically different but of minimal importance: the majority were Hindu in both groups and lived in a village other to their original village

Inclusion criteria: School-aged children, positive Child Psychosocial Distress Screener score (cut-off score unspecified)

Exclusion criteria: Psychiatric problems (mutism, mental retardation, dissociative disorders, epilepsy without medication, panic or phobic disorders, and child psychosis), schools excluded if they were in Village Development Committees (VDCs) where the intervention was already implemented and schools in adjoining VDCs to avoid contamination


InterventionsStated purpose: To assess the efficacy of CBIs among school-going children in rural Nepal as a psychosocial intervention to address children affected by armed conflict in LAMIC

INTERVENTION:

Name: CBI

Delivered by:

  • Title/name of NSHW/OPHR and number: 16 paraprofessional interventionists /facilitators
  • Selection: Gender-balanced group, from targeted communities
  • Educational background: Based on previous experience and affinity to work with children
  • Training: 15-day skills-oriented course (duration and trainers not specified)
  • Supervision: Regular supervision by experienced counsellor
  • Incentives/remuneration: Information from author: The facilitators received a monthly remuneration of 4000 NPR for running the CBI sessions


Intervention details:

  • Duration/frequency: 5 weeks, 15 sessions (about 60-minute sessions)
  • Content of intervention: Protocolised group intervention; eclectic intervention based on concepts from creative-expressive and experiential therapy, co-operative play and CBT. Use of the same manual as for Tol 2008 (Center for Trauma Psychology in Boston)


CONTROL: Usual care (wait-list control)

CO-INTERVENTIONS: CBI was offered as part of a multilayered care system that included activities geared towards strengthening community resilience through parental support groups, recreational activities, community sensitisation and psycho-education (tier 1), the CBI to target children with elevated psychosocial distress upon primary screening (tier 2), and individual supportive and problem-solving counselling and referral to psychiatric care (if available) for children, mainly referred on from the group intervention, in need of more individualised or specialised care (tier 3)


OutcomesPatient: SCARED (anxiety)*, Children's Aggression Scale for Parents* § (physical aggression), CPSS (Child PTSD)*, DSRS*, SDQ* §. Secondary outcomes:Concern for other scale § (prosocial behaviour), Children's Function Impairment (protocol mentioned secondary outcomes would also be daily functioning and self efficacy - these are not reported here)

Carer: n/a

Process/health worker outcomes: Not assessed

Economic outcomes: None

Time points: Baseline and 3-month follow-up

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)


NotesSource of funding: Save the Children USA (Nepal Office)

Notes on validation of instruments: Translated and validated, "Test–retest reliability of the instruments was determined among 20 participants"; 1 screening measure, the CPDS, was developed for Nepali context specifically and described in Bolton 2002

Additional information: www.controlled-trials.com/ISRCTN48004304/ISRCTN48004304

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: SRCTN48004304


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Allocation to study conditions followed a three-step procedure. First, districts were randomly allocated to either CBI or control condition (2 CBI districts, 2 wait- list districts). Second, two schools per district were randomly selected from a list of all eligible schools. Exclusion criteria for schools were (a) schools in Village Development Committees (VDC; the smallest administrative unit in Nepal) where CBI had already been implemented and schools in adjoining VDCs to avoid contamination; (b) schools in parts of the district with large geographic or ethnic differences compared to the majority of the district to increase group homogeneity within districts. Third, children were randomly selected from a list of all children aged 11-14 years in the school. The randomisation was done, without imposing a randomisation constraint, by use of computer-generated random numbers (in SPSS) by the research team in Amsterdam. Out of 53 eligible schools, 8 were randomly selected with a total of 1367 eligible children of whom 149 were absent and 30 refused"

Allocation concealment (selection bias)High riskQuote: "Randomisation was done, without imposing a randomisation constraint, by use of computer-generated random numbers (in SPSS) by the research team in Amsterdam"

Comment: Schools, districts and students randomised through computer-generated random numbers by research team in Amsterdam but still not clear whether at the point of allocation whether the allocation concealed

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: School children and teachers could not be blinded due to nature of intervention. But outcomes unlikely to be affected by blinding

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
High riskComment: Research assistants not blinded to treatment condition; interviewed children's self report (children not blinded to treatment condition)

Baseline outcome measurements similarUnclear riskComment: Report that no significant baseline differences between boys and girls on outcomes but data not presented between control and intervention groups. Baseline outcome measures seem similar between both groups (table 2) except perhaps SCARED, physical aggression and prosocial behaviour. In addition, noted in limitations that SCARED reliability between assessors was poor, so may not be reliable

Baseline characteristics similar?Low riskComment: Baseline differences in gender, ethnicity, religion, place of residence and level of education which were adjusted for

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: Lost to follow-up at T2, 2 in treatment group, 0 in wait-list control group

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskInformation from author: "There were no adverse outcomes"

Protection against contaminationLow riskComment: Cluster design which is unlikely to lead to contamination and wait-list control

Reliable primary outcome measuresLow riskQuote: "Internal reliability of some of the instruments was low, especially for the SCARED-5, which hampers pre-post intervention comparisons"

Comment: Inter-rater reliability between assessors was 0.891 for dichotomous items and 0.972 for continuous

Selective reporting (reporting bias)Low riskComment: 2 secondary outcomes reported in protocol are not reported in results (self efficacy and daily functioning)

Author response: "With regards to the secondary outcomes; (a) 'daily functioning' has been included in the paper but has been renamed as 'functional impairment' (following the paper that was written on the development and validation of that scale); (b) 'self-efficacy' was included in the protocol, but no instrument was found with sufficient cross-cultural validity. As a result we have opted to include a 'coping scale (KID-COPE)', which was not included in the reporting because of unforeseen problems with the analyses (i.e. we were not able to adequately analyse the combined response format of dichotomous and ordinal scales per respondents of the KID-COPE)"

Comment: Good explanation

Other biasLow riskComment: ICC done and adjustment for clustering

Li 1989 RCT China

MethodsStudy design: RCT

Duration of study: April-August 1986


ParticipantsCountry: China

Income classification: Upper middle

Geographical scope: Rural. The trial conducted in 2 provinces:
1. Beijing: Bei Cangxiang Township, Da Xing County in Beijing. It is 40 km from the downtown areas of Beijing. The local resident had middle-level living standard
2. Si Chuan Province: 3 townships (Shi Jian, Feng An, and Jian Xin) in Ren Shou County. These townships were remote hilly terrain, which are 30 km from the county town and transportation not convenient. The local resident's living standard was low and medical condition was poor

Healthcare setting: Community. Epilepsy patients identified through door-to-door visits by village doctors

Mental health condition: Epilepsy patients

Population (mention if patient, carer or dyads): Epilepsy patients

  • Age: 4-64 years
  • Gender: Male 21, female 19
  • Socioeconomic background: 24 patients were from poor remote rural area and 16 patients were from middle-level rural area
  • Inclusion criteria: 1. Athermal (primary or secondary) systemic rigidity clonus type grand mal epilepsy; 2. epileptic seizure more than 3 times within 3 months before enrolment, and at least 1 time that someone witness
  • Exclusion criteria: 1. Seizures during pregnancy; 2. febrile seizure; 3. weight < 10 kg; 4. < 2 years old; 5. progressive disease of the nervous system; 6. serious mental disorder or mental deficiency; 7. attention deficit hyperactivity disorder (ADHD); 8. diseases of heart, liver or kidney, or severe hypertension; 9. history of status epilepticus; 10. undergoing regular western medicine treatment based on psychiatrist judgements; 11. epileptic seizure related to alcohol or drug dependence


InterventionsStated purpose: To compare the effectiveness of epilepsy treatment regimen provided by trained village doctors with treatment by psychiatrists, as well as patient's reliance on village doctors with psychiatrists

INTERVENTION:

Name: Standard epilepsy treatment regimen provided by village doctors

Delivered by NSHW

  • Title/name of NSHW/OPHR and number: Trained village doctors
  • Selection: Selected village doctors and trained for 3-5 days
  • Educational background: Not mentioned
  • Training (contents, duration and by whom): 3-5 days training on the standard treatment regimen and how to deal with common side effects
  • Supervision: Not mentioned
  • Incentives/remuneration: Not mentioned


Intervention details:

  • Duration/frequency: Treatment regimen was 3-4 months, and follow-up the patients once every 2 weeks
  • Content of intervention: Village doctors identified patients through door-to-door visits. Their diagnosis was then checked by a psychiatrist. Village doctors then provided standard regimen of phenobarbital for epilepsy


CONTROL: Psychiatrists provided phenobarbital treatment and can adjust the dosage according to the patients disease severity

CO-INTERVENTIONS: None


OutcomesPatient: Number of epileptic seizure per month*; adverse events; treatment adherence § (number of patients taking medicine according to prescription, number of patients with return visit on time)

Carer: None

Process/health worker outcomes: None

Economic outcomes: None

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: Baseline, 3 months, 4 months


NotesSource of funding: WHO

Notes on validation of instruments (screening and outcomes): None

Additional information (e.g. provide by authors, existence of a published study protocol): No study protocol so unable to check primary and second outcomes

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: None (only feasibility trial)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: Not specified how the random sequence generated

Allocation concealment (selection bias)Unclear riskComment: Not specified

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Patients were not blinded as it compared the phenobarbital treatment provided by different health providers

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: Not specified whether outcome assessors blinded or not, but the outcomes were mainly objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskComment: None

Baseline outcome measurements similarUnclear riskComment: Not reported if the baseline outcome measurements were similar

Baseline characteristics similar?Unclear riskComment: Not clear about whether baseline characteristics substantially different between 2 groups

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: 100% follow-up

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskQuote: "2 person-time were not visit doctor on time"

Comment: Safety outcome measures obtained for more than 80% of subjects randomised

Protection against contaminationLow riskComment: Community randomisation

Reliable primary outcome measuresUnclear riskComments: Reliability is not reported for outcome measures

Selective reporting (reporting bias)Low riskComment: No protocol. Author suggests all outcomes reported

Other biasLow riskComment: None

Loughry 2006 CBA Palestin

MethodsStudy design: CBA study

Duration of study: 2003 (exact time not specified)


ParticipantsCountry: Palestinian territories

Income classification: Lower-middle

Geographical scope: Urban in the following areas; Intervention: West Bank (Ramallah, Al Kader, Hebron, and Jericho) and Gaza (Rafah and Beit Hanoun); Control: West Bank (Al Doha) and Gaza (Khan Younis)

Healthcare setting: Child and youth centres

Mental health condition: Psychosocial difficulties, including behavioural problems (elevated CBCL scores)

Population: Patient

  • Age: 6-11 and 12-17 years recruited in equal proportions for each age range in intervention group
  • Gender: Both
  • Socioeconomic background: Conflict area, previous studies report 93% of children report not feeling safe, 45% had personal experience with violence from conflict, tension in territories and subject to military incursions, curfews, and restricted movement of populations
  • Inclusion criteria: Children were recruited to the study at the time of registering for programme activities when they commenced in 2003
  • Exclusion criteria: Not specified


InterventionsStated purpose: This study examined the impact of child-focused interventions for children exposed to political conflict involving structured activities, supported by provision of equipment and training of facilitators

INTERVENTION:

Name: Structured activities for children

Delivered by:

  • Title/name of NSHW/OPHR and number: Local young adult volunteers (number not specified)
  • Selection: Not specified
  • Educational background: Not specified
  • Training: Training facilitated and funded by 2 NGOs. The content and duration of the training is not specified
  • Supervision: Not specified
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: Week nights and weekend, during school holidays there were week-long camps, duration unspecified
  • Content of intervention: "The interventions sought to support the resilience of children living in this situation, and principally addressed this by enabling (through provision of equipment and training) the delivery of structured activities." "The focus was to provide children and their parents with greater opportunities to participate in recreational, cultural and other non-formal activities in a safe setting. The children's activities included after-school recreation activities in a community setting, 'connectivity' activities (e.g., summer camps, using the internet to put children in touch with other children in different settings, etc.), and for one of the non-government organisations, the establishment of 'safe play' areas (Loughry and Ager, 2004). The activities for the children's parents included information classes as well as opportunities to join with their children in structured recreational activities." But also both organisations had different emphases and time frames: "Both non-government organisations trained local young adult volunteers in how to conduct structured activities for children. Emphasis was given to cultural and recreational activities, such as traditional dancing, art work, sports, drama and puppetry, though after-school educational activities were also covered. Once trained, these volunteers facilitated these activities in local recreation centres on week nights and weekends. In school holidays, these activities formed the basis of week-long holiday camps. The training and material for these activities were facilitated by funding from the two non-government organisations. In addition, one of the non-government organisations focused on activities that were designed to increase the children's sense of 'connectivity' with Palestinian children in other geographical areas as well as with children living abroad. This was done through the provision of computers with internet access and training in the use of the internet, as well as organised outings to other community centres. The other non-government organisation emphasised the development of ‘safe’ outdoor settings. These settings were playgrounds equipped with recreation equipment and supervised by adults"


CONTROL: Usual care, comparison group sites, families receiving non-psychosocial services (e.g. water and sanitation assistance) from same 2 NGOs as in intervention group

CO-INTERVENTIONS: See above, the interventions provided at the 2 NGO locations differed - in addition to the base cultural/recreational activity intervention, 1 focused on activities designed to increase connectivity with other geographical areas through computers, and 1 emphasised safe outdoors settings with playgrounds/recreational equipment


OutcomesPatient:CBCL (parent report), Hopefulness (component of the Child Adolescent Measurement Scale; child report), PSS (child report)

Carer: n/a

Process/health worker outcomes: Not reported

Economic outcomes: None

Time points: Baseline and 12 months


NotesSource of funding: Bill & Melinda Gates Foundation

Notes on validation of instruments: CBCL taken from University of Vermont where it had been translated and used before in Arabic; PSS was designed for Palestinian population and validated (Khamis 2000), unspecified for Child Adolescent Measurement Scale (Khamis 2000)

Additional information: No protocol found

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: None given


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskComment: Non-randomised intervention

Allocation concealment (selection bias)High riskComment: CBA study

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: Unspecified if personnel were blinded

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
High riskQuote: "The interviewers had purposefully not been informed of the goals of the intervention"

Comment: Child and parental report of outcomes (not blind to intervention) as part of interview done by interviewers uninformed of intervention goals

Baseline outcome measurements similarHigh riskComment: Intervention group had higher hopefulness and PSS scores than comparison at baseline (P value < 0.01)

Baseline characteristics similar?High riskQuote: "Intervention and comparison groups were broadly well matched in terms of the five outcomes measures. Adjusting for alpha at .05/5 1⁄4 .01, it was found that there was no difference in the CBCL Total, Internalising or Externalising problem scores at baseline between the children who subsequently took the intervention and those who did not (F(1,398) 1⁄4 .00, p > .01, F(1, 398) 1⁄4 .25, p > .01, and F(1,398) 1⁄4 1.08, p > .01, respectively). However, the children in the intervention group did begin with higher hopefulness and PSS scores than those in the comparison group (F(1,396) 1⁄4 19.55, p < .01, and F(1,397) 1⁄4 13.39, p < .01, respectively)"

Comment: Difference between intervention and comparison groups

Incomplete outcome data (attrition bias)
Efficacy data
Unclear riskComment: Not clear in report of data if there was lost to follow-up

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No adverse outcomes reported

Protection against contaminationHigh riskComment: Other humanitarian efforts ongoing, including other CBI programmes across Palestinian schools during study period, risk of outside contamination (although contamination between intervention and control groups minimal)

Reliable primary outcome measuresLow riskComment: Good internal reliability reported for PSS and Hopefulness scale and tools validated (see reference under notes)

Selective reporting (reporting bias)Low riskComment: Outcomes reported in methods reported in results

Other biasLow riskNone reported

Lyketsos1999CBA Argentina

MethodsStudy design: CBA study (PC officers vs. psychiatric clinic)

Duration of study: Not mentioned but study done in 1996 published in 1999


ParticipantsCountry: Argentina

Income classification: Upper-middle income country

Geographical scope: Urban, in Buenos Aires.

Healthcare setting: PC (intervention) and psychiatric hospital practice (control)

Mental health condition: Major depressive disorder

Population: Adults

  • Age: > 18 years (not specified; also included > 60 years)
  • Gender: Both
  • Socioeconomic background: Not specified
  • Inclusion criteria: Quote: "Males and females older than 18 years; females with childbearing potential with a negative pregnancy test who practiced successful contraception for at least 3 months before entering the study; patients met DSM-IV criteria for major depressive disorder (MDD); a score of at least 10 points on the 17-item Hamilton Depression Rating Scale"
  • Exclusion criteria: Women who were pregnant, lactating, or of childbearing potential; not using reliable contraception; or who intended to become pregnant within 3 months of study entry. Diagnosis of seizure disorder, organic brain disease, malignancy, schizophrenia, psychotic disorder, anorexia, nervosa, or bulimia nervosa, severe allergies or multiple adverse drug reactions by history, hypertensive patients being treated with reserpine or alpha methyldopa, other clinically significant current active medical disorder that would interfere with study participation, known hypersensitivity to sertraline or lactose, history of alcoholism, drug abuse, personality disorder, poor motivation, or other emotional problems likely to invalidate informed consent, very high current suicidal risk, in the opinion of the treating physician


InterventionsStated purpose: To compare the clinical profile of patients with major depression seen in PC office practice with that of those seen in psychiatric office practice and to investigate whether comparable treatment outcomes regarding depression remission can be achieved in both settings, using a structured, open-label pharmacological intervention

INTERVENTION 1:

Name: Response to sertraline (antidepressant) in PC

Delivered by

  • Title/name of NSHW/OPHR and number: 113 PC physicians
  • Selection: Volunteers to contribute cases to study
  • Educational background: Physicians with a medical degree
  • Training: All participating physicians received half a day of training by a board-certified psychiatrist in the diagnosis of MDD and in the scoring of the HDRS. They were also provided with a checklist of depressive symptoms to assist in the diagnosis of MDD
  • Supervision: By support staff "who visited the practices to provide medication supplies, answer design questions, and collect the data"
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: Acute intervention; prescribing the drug sertraline and enhancing the dose. Protocol consisted of: "sertraline beginning at 50 mg per day for 4 weeks. After 4 weeks (at follow-up Day 29), the treating physicians had the choice of increasing the dose of sertraline to 100 mg." There was no psychological intervention offered
  • Content of intervention: Pharmacological intervention as above


CONTROL: Specialist (gold standard); psychiatrist office practitioners who also were trained in using the protocol (using DSM-IV and HDRS, and then sertraline 50 mg with an option to increase dose to 100 mg 4 weeks later)

CO-INTERVENTIONS: None


OutcomesPatient: Clinical outcomes after treatment with antidepressants. The primary outcome measure was the HDRS*. Secondary outcome measures included rates and severity of adverse events, reasons for discontinuation §, compliance § (> 80% of doses taken), and the number of patients who required antidepressant dose escalation at the day 29 visit §.

Carer: Not applicable

Process/health worker outcomes: None

Economic outcomes (and where these can be found e.g. ref or table number): Not done

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: The patients were seen for follow-up at days 8, 15, 29 and 56 after initiation of treatment


NotesSource of funding: Grants from CEMIC and from the Pfizer Corporation.

Notes on validation of instruments: HDRS with a cut-off score of 10 was used; but not specified whether version used was locally validated or not

Additional information: Nothing of significance, no published protocol

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Not mentioned


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "This was a consecutive series of patients who met the ... inclusion and exclusion criteria"

Allocation concealment (selection bias)High riskQuote: "Comparative, open-label study of patients"

Comment: No allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: No blinding. No placebo, so not sure if blinding would have had an impact on outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: Adverse events reported

Blinding of outcome assessment (detection bias)
subjective outcomes
High riskQuote: "Provided with a checklist of depressive symptoms to assist in the diagnosis of MDD"

Comment: Standard instrument utilised and administered after training. However, these are administered by the clinician (physician or psychiatrist) so not blinded. So high risk

Baseline outcome measurements similarLow riskComment: Baseline primary outcome similar

Baseline characteristics similar?High riskQuote: "The patients in primary care were older by an average of 8 years, more likely to have active medical illnesses, less likely to be abusing alcohol, and less likely to have received prior treatment for depression during the present episode. The two groups were comparable on other variables" viz. gender and mean days in present episode

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: Only about 15% dropout rate

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskComment: Adverse events reported

Protection against contaminationUnclear riskComment: Exclusion criteria did not mention excluding participants seeking psychiatric treatment. So perhaps there was a risk that patients could have been included in both arms. This risk was low; however, it is unclear whether patients could still have seen a psychiatrist

Reliable primary outcome measuresLow riskQuote: "The patients in the study were not evaluated in a structured diagnostic examination. This would have been expensive in this size study. To guard against diagnostic inaccuracies, the physicians making diagnoses were trained in diagnostic assessment for the study and in rating the Ham-D [HDRS], and a minimal rating of 10 on the Ham-D was required for study inclusion"

Selective reporting (reporting bias)Unclear riskComment: No selective reporting. but no protocol, so check with authors to check if pre-intervention specified outcomes have been reported

Other biasLow riskComment: None detected

Neuner 2008 NRCT Uganda

MethodsStudy design: Quasi-randomised, parallel group, assessor blinded, 3-armed, controlled clinical trial

Duration of study: 2003-2004


ParticipantsCountry: Uganda

Income classification: Low

Geographical scope: Nakivale refugee settlements in Uganda for Somali and Rwandan refugees; semi-rural (2 refugee camps close to base hospital)

Healthcare setting: Home-based care

Mental health condition: PTSD

Population: Patients

  • Age: > 18 years; mean age 34-36 years (SD 12-14 years) in the 3 groups
  • Gender: Both
  • Socioeconomic background: Refugees from Somalia and Rwanda
  • Inclusion criteria: Fulfilling DSM IV criteria for PTSD (assessed using the PDS; consent to participate
  • Exclusion criteria: Drug abuse, obvious mental retardation; psychosis


InterventionsStated purpose: To evaluate whether trained counsellors from the local afflicted population can effectively deliver a manual-based approach to counselling victims of civil war trauma, and to compare the structured manual-based approach with a more flexible approach or no specific intervention

INTERVENTION 1:

Name: NET; 111 people

Delivered by: LHW (residents of refugee camps trained in counselling for the study)

  • Title/name of NSHW/OPHR and number: Counsellors (9 in total; Somali and Rwandan refugees; 5 women, 4 men; mean age 27 years)
  • Selection: Literacy in English and their mother tongue; ability to empathise with their clients; strong motivation
  • Educational background: Secondary school (7); primary school (1); university (1)
  • Training: 6 weeks of general counselling skills; NET and TC given by 5 post-doc and doctoral university personnel from Germany and Uganda; used the NET manual, and case discussions. 5 of the trainees had PTSD (3 lifetime, 2 current) and were given individual NET by trainees
  • Supervision: Weekly case and personal supervision by trainers; treatment adherence monitored by case discussions during supervision, direct observation of treatment sessions, and review of patient testimonies and treatment protocols
  • Incentives/remuneration: Not stated in this report


Intervention details:

  • Duration/frequency: 6 sessions (2 per week for 3 weeks); 1-2 hours' duration
  • Content of intervention: Manualised, structured reconstruction of chronology of biography incorporating traumatic events into a coherent narrative; emphasis on reliving and describing emotional, physiological, cognitive and behavioural reactions to traumatic events; and habituation of reactions. Final narrative report (psycho-education about PTSD in initial sessions; written rationale about relationship between PTSD and multiple past trauma; written chronological autobiography of traumatic experiences given to participant)


INTERVENTION 2:

Name: TC; 111 people

Delivered by: LHW (residents of refugee camps trained in counselling for the study; same as those who gave NET)

  • Title/name of NSHW/OPHR and number: Counsellors (9 in total; Somali and Rwandan refugees; 5 women, 4 men; mean age 27 years)
  • Selection: As above
  • Educational background: As above
  • Training: Flexible, less directive approach than NET; developed through discussions with trainees and by experienced senior counsellor from Uganda; training sessions focused on the psychological and social needs, conflicts and current life problems of clients; related current problems to past traumatic experiences; counsellors also trained in non-directive active listening; problems solving; exploring coping skills and grief interventions
  • Supervision: Weekly supervision assisted by experienced senior Ugandan counsellor
  • Incentives/remuneration: Not stated


Intervention details:

  • Duration/frequency: 6 sessions (2 per week for 3 weeks) 1-2 hours' duration
  • Content of intervention: Not manualised but used a flexible approach focusing on current psychological and social needs of clients; NET considered a part of this approach but was not mandatory. Psycho-education about PTSD in initial sessions; written rationale about relationship between PTSD and multiple past trauma developed; final report contained in mother tongue of participant the current and past problems discussed with the counsellor and possible solutions and coping strategies.


CONTROL: Monitoring group (no treatment) who were told they would be eligible for NET or TC if they proved effective; 55 people

CO-INTERVENTIONS: Not stated


OutcomesPatient: 1. PDS (Foa 2005; contains 17 items of DSM IV for PTSD; translated and linguistically adapted; standard methods to translate and back-translate from Afsomali and Kinyaruwanda; (methods published separately); used to make DSM IV diagnoses of PTSD at baseline, 3 months and 6 months by 12 trained research assistants blind to allocation; 2. Expert evaluation: using PTSD section of the Composite International Diagnostic Interview (WHO 1997), by PhD level psychologists or graduate students (number not stated) at 9 months, blind to allocation; 3. Physical health checklist; sum of scores of symptoms of common illnesses over last 4 weeks (not validated)

Carer: Not applicable

Process/health worker outcomes: Not reported

Economic outcomes (and where these can be found, e.g. ref or table number): Not reported

Time points: Baseline for all: 3, 6 and 9 months for intervention groups; 3 and 9 months for monitoring group


NotesSource of funding: German funding agencies (DFG; BMZ)

Notes on validation of instruments (screening and outcomes): Psychological outcomes validated; physical symptoms checklist not validated

Additional information (e.g. provide by authors, existence of a published study protocol): Translation of instruments published

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Not prospectively registered


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote from report: "The list of participants was ordered randomly; the first 4 were consecutively assigned to NET (narrative exposure therapy), TC (trauma counselling). NET, TC and the fifth was assigned to the MG (monitoring) group.This procedure was repeated until all 277 participants were assigned"

Comment: Alternate assignment; prone to prediction of next allocation and to high risk of bias; baseline imbalances in nationalities due to lack of stratification

Allocation concealment (selection bias)High riskComment: Allocation not concealed; participants were approached at home and allocated treatments after randomisation; baseline imbalances in prognostic variables evident

Blinding of participants and personnel (performance bias)
All outcomes
High riskComment: Open-label trial; group supervision of cases also precludes effective blinding; counsellors used both interventions, risk of contamination present, as well as of differential interventions

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: Outcome assessors were not aware of treatment allocation; no objective outcomes used

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskComment: Outcome assessors were blind to allocation

Baseline outcome measurements similarUnclear riskComment: The mean (SD) for the PTS diagnostic scale in the NET and TC groups were similar at baseline (25.9 (13.2) and 26.7 (12.5), respectively); however, it was lower in the control group (21.3 (10.3)). Unclear if this is a significant difference

Baseline characteristics similar?High riskComment: Baseline differences in proportion of Somali and Rwandan refugees in intervention groups with highest % of Rwandan nationals in monitoring group (79%), and lowest in NET group (32%) (P value < 0.01). Somali participants had more trauma than Rwandan participants; analyses in report adjusted for this difference but is unlikely to have eliminated risk of bias

Incomplete outcome data (attrition bias)
Efficacy data
High riskComment: Dropouts more than 65% in all groups; significantly high differential dropout rates

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskComment: No safety data reported

Protection against contaminationHigh riskComment: Contamination likely as same therapists used NET and TC; NET was a manualised treatment and TC is expected to incorporate NET; but it is also possible that participants discussed treatments among themselves in the refugee camps, and further contaminated the fidelity of the interventions

Reliable primary outcome measuresLow riskComment: Main psychological outcomes used validated tools

Selective reporting (reporting bias)Unclear riskComment: Trial not prospectively registered; protocol not available; yet we could detect no evidence of selective reporting

Other biasLow riskComment: None detected

Noknoy 2010 RCT Thailand

MethodsStudy design: RCT

Duration of study: 2003-2004


ParticipantsCountry: Thailand

Income classification: Upper-middle

Geographical scope: Rural

Healthcare setting: PCUs - 7 in north-east Thailand and 1 in central Thailand

Mental health condition: Hazardous drinking

Population: Hazardous drinkers

  • Age: 18-65 years
  • Gender: Both, but majority (91%) male
  • Socioeconomic background: Predominantly have primary and secondary education, married
  • Inclusion criteria: 18-65 years old, AUDIT score ≥ 8
  • Exclusion criteria: Alcohol-dependent patients (DSM-IV criteria), history of liver disease, history or regular early morning drinking, recent extremely high consumption (> 120 g for men or > 80 g women), neurological and psychiatric disorders, pregnant women, outside age range


InterventionsStated purpose: Determine effectiveness of MET for hazardous drinkers in PCU settings

INTERVENTION 1:

Name: MET

Delivered by

  • Title/name of NSHW/OPHR and number: 8 nurses
  • Selection: Nurses from each of the selected PCUs (only 1 nurse per PCU)
  • Educational background: Nursing degree
  • Training (contents, duration and by whom): 6 hours' training by a psychiatrist, and consisted of understanding the standard drink measurement, the stage of change and MET
  • Supervision: Not specifically planned but nurses could contact main author (GP working in PC) by telephone for any difficulties or clarifications
  • Incentives/remuneration: None


Intervention details:

  • Duration/frequency: 3 scheduled sessions: on day 1, at 2 weeks and at 6 weeks after the baseline evaluation. Each session comprised ∼15 minutes of counselling
  • Content of intervention: Evaluation of the patient's ability to change his drinking habits according to the stage of change. For patients in the pre-contemplation stage, the main technique was feedback, using reflection and questioning skills to elicit self motivational statements. If change was contemplated, the study nurse would work with the patient's ambivalence using a pros and cons technique. At the same time, an empathic counselling style and encouragement of the patient's self efficacy were used to support change in drinking behaviour. Subsequently, each participant's readiness to change drinking behaviour was assessed. If in the determination stage, options on how to reduce drinking behaviour were provided


CONTROL: Patients without MET intervention, who were told that the trial focused on health behaviours, which included questions on smoking, exercise, eating behaviour, weight and alcohol use (to minimise intervention effect on health behaviour)

CO-INTERVENTIONS: None


OutcomesPatient: AUDIT tool (for screening); outcome measures: health survey questionnaire that included amount of alcohol consumption in the previous week*, measured in 4 ways (mean drinking/per drinking day/previous week, hazardous drinking/drinking day/previous week, mean drinking/per week, hazardous drinking/per week) and number of episodes of binge drinking in 7 days, frequency of accidents and traffic accidents and frequency of being drunk in the last month. GGT: blood test for evaluation of current drinking severity§, and honesty/accuracy of patient information through collateral informant interviews§

Carer: None

Process/health worker outcomes: None

Economic outcomes: None

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: Baseline, 6 weeks (post-intervention), 3 months, 6 months


NotesSource of funding: Thai Health Promotion Foundation

Notes on validation of instruments: AUDIT is validated but not the health survey

Additional information: Provided by authors for characteristics of NSHWs and intervention

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: No protocol


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "The unit of randomisation was the individual patient. Randomization of subjects to the intervention and control groups was carried out from the Coordinating Centre in Phramong-Kutklao Hospital in Bangkok using a standard randomisation table. Each PCU had both control and intervention groups. In order to keep both groups of similar size, random allocation was done in blocks. On average, the trial was to have 6–8 participants in each study condition in each PCU"

Allocation concealment (selection bias)Low riskQuote: "Randomization codes were distributed to each PCU in sealed envelopes. Eligible study participants were enrolled by health personnel when subjects"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "In order to minimize the intervention effect of the research procedures, the subjects randomised into the control condition were told that the trial focused on health behaviours, which included questions on smoking, exercise, eating behaviour, weight and alcohol use. The study interviewers at follow-up visits were not aware of the assignment allocation of the study participants"

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: Less than 20% of those were meant to have GGT test dropped out

Blinding of outcome assessment (detection bias)
subjective outcomes
High riskComment: The tools were not validated

Baseline outcome measurements similarLow riskComment: All similar

Baseline characteristics similar?Low riskComment: All similar

Incomplete outcome data (attrition bias)
Efficacy data
High riskComment: There is < 20% dropout rate in intervention between baseline and last follow-up; however, there is more than 20% dropout rate in the control group. May affect the outcomes. No mention about analysis of the control dropouts, therefore classify as high risk

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
High riskInformation from author: "We didn't look for the adverse event. However, I have found that there was problems there were some cases of participants that need to be excluded as it was not originally detected"

Comment: they have not searched for adverse events of the intervention

Protection against contaminationLow riskQuote: "In order to minimize the intervention effect of the research procedures, the subjects randomised into the control condition were told that the trial focused on health behaviours, which included questions on smoking, exercise, eating behaviour, weight and alcohol use"

Comment: Also unlikely contamination between groups as dispersed communities (clinics) and not aware the intervention was regarding alcohol necessarily

Reliable primary outcome measuresHigh riskComment: Many subjective outcomes but GGT objective - but not always specific to alcohol disease

Selective reporting (reporting bias)Low riskComment: All outcomes reported

Other biasHigh riskComment: The trial showed an increase in GGT at 6 months in both groups possibly because baseline data was collected just after 'Kao Pansaa' a 3-month Buddhist retreat where it is customary for people to avoid wrongdoing including reducing drinking

Papas 2011 RCT Kenya

MethodsStudy design: Randomised, gender-stratified, parallel group, open-label, controlled clinical trial

Duration of study: February to December 2009


ParticipantsCountry: Kenya

Income classification: Low income

Geographical scope: Urban, HIV clinic affiliated with Moi Teaching and Referral Hospital, Eldoret, Kenya

Healthcare setting: Outpatient clinic

Mental health condition: Hazardous use of alcohol or binge drinking

Population: Patients

  • Age: ≥ 18 years
  • Gender: Both
  • Socioeconomic background: Not specified
  • Inclusion criteria: ≥ 18 years, enrolment as an AMPATH HIV outpatient attending the Eldoret clinic affiliated with Moi Teaching and Referral Hospital, hazardous or binge drinking criteria (score ≥ 3 on the AUDIT-C, or more than 6 drinks per occasion at least monthly), any alcohol use in the past 30 days, being antiretroviral eligible or antiretroviral initiated in the past 12 months, spoken knowledge of Kiswahili, living within 1 hour's travelling distance from the clinic, no plans to move further away during the study period and being available during the weekly group time
  • Exclusion criteria: Active psychosis or suicidal, attendance in the past year at an existing AMPATH alcohol peer support group or participation in the study’s group CBT pre-pilot development


InterventionsStated purpose: To use CBT due to empirical evidence of success in reducing risky behaviours in African HIV-infected people, and its structured format that makes it feasible to train paraprofessionals

INTERVENTION 1:

Name: CBT, 42 people

Delivered by: OPHR

  • Title/name of NSHW/OPHR and number: 2 CBT counsellor (1 male; 1 female)
  • Selection: Knowledge of English and Kswahili; essays and role plays to assess empathy, emotional perceptiveness; good communication skills and analytical abilities; met certification criteria for CBT training (adherence and competence)
  • Educational background: High-school
  • Training (contents, duration and by whom): Trained by study personnel; 175 hours of training; classes, role plays, videotaped feedback with medical students as simulated patients; assessment of adherence and competency using the YACS
  • Supervision: 300 hours of supervision prior to trial; during the trial, all CBT group sessions were videotaped and monitored weekly by 1 experienced CBT supervisor. Supervision was conducted via telephone during the latter stages of trial. 50% of sessions with men and women, respectively (18 sessions) were selected randomly, translated into English, with random back-translation verification, and rated by 2 highly experienced YACS raters from the Yale Psychotherapy Development Center
  • Incentives/remuneration: Not stated


Intervention details:

  • Duration/frequency: 6 weekly, gender stratified 90-minute group CBT sessions; 7 participants per group delivered by same-sex CBT counsellor
  • Content of intervention: Manual-based CBT. Abstinence from alcohol was set as goal and a quit date was decided during the second session; behavioural analysis; risky behaviours and alcohol refusal skills reinforced


CONTROL: Routine medical care provided by the clinic (33 people)

CO-INTERVENTIONS: Not reported


OutcomesPatient: Percentage of drinking days*; mean drinks per drinking days; abstinence at longest follow-up §; adherence to CBT sessions §

Carer: Not applicable

Process/health worker outcomes: Adherence and competence to CBT

Economic outcomes: Not reported

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: 30 days; 60 days; 90 days post treatment


NotesSource of funding: National Institute on Alcohol Abuse and Alcoholism-funded grant (R21AA016884) USAID-AMPATH Partnership from the United States Agency for International Development (President’s Emergency Plan for AIDS Relief and P50DA09241)

Notes on validation of instruments (screening and outcomes): Validated outcome tools

Additional information (e.g. provide by authors, existence of a published study protocol): Not applicable

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Clinicaltrials.gov identifier: NCT00792519


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "A stratified simple randomization procedure was used to form gender-stratified cohorts. Within gender-based cohorts, participants were assigned randomly until a minimum was achieved of seven CBT and five usual care participants, thereby creating some waiting time. A group of seven was required for CBT to enhance participation, while fewer were required for the individual usual care condition to minimize waiting time before treatment initiation"

Allocation concealment (selection bias)Low riskQuote: "Each participant was randomized after she or he drew from a jar a paper with the name of the condition. The papers were prepared by study administrators to conceal the name of the condition during the drawing, which was supervised by staff"

Comment: Allocation was possibly concealed

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: not blinded but also was not possible. No likely effect on outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: Three alcohol saliva tests came back positive during treatment phase. This showed concordance with patient's self reported or scored outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Unclear riskQuote: "Non-blinded research assistants both recruited and interviewed participants; none delivered study interventions"

Comment: Unlikely that if they did not deliver the intervention that there was much bias

Baseline outcome measurements similarLow riskComment: All similar

Baseline characteristics similar?Low riskComment: All similar

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: 36/42 completed intervention; 32/33 stayed in control (completers), i.e. less than 20% drop outs

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: Not reported

Protection against contaminationLow riskComment: RCT occurring just in one clinic. The lessons from CBT therapy could therefore have been shared within the population between controls and those in CBT intervention. However a large number of people were enrolled at the clinic suggesting its geographical remit is very wide

Reliable primary outcome measuresLow riskQuote 1: "An initial sample of six tapes was rated by two independent raters and indicated a high level of inter-rater reliability (mean intraclass correlation coefficients) across both adherence (mean = 0.98) and competence (mean = 0.95)"

Quote 2: "Overall level of drinking was low in the trial, i.e. at the 90-day follow-up 69% of CBT participants reported abstinence and PDD was 5%. There were six positive saliva tests, three in CBT and three in usual care; five occurred during the treatment phase"

Comment: This latter statement suggests good correlation between physical objective findings (saliva tests) and the scored outcomes

Selective reporting (reporting bias)Low riskComment: All outcomes mentioned in methods section were reported. The trial was prospectively registered and primary outcomes were identical: quantity and frequency of alcohol use

Other biasLow riskComment: None detected

Paranthaman2010CBAMalaysi

MethodsStudy design: CBA study

Duration of study: Not specified which years of recruitment and intervention. Intervention length: 6 months


ParticipantsCountry: Malaysia

Income classification: Middle

Geographical scope: Urban/semi-urban

Healthcare setting: Community psychiatric free-standing clinic

Mental health condition: Schizophrenia

Population: Patient carer dyads

  • Age: Patient mean age (SD): 41.5 years (14.2), carers: mean age (SD) 53.1 years (13.5)
  • Gender: Both
  • Socioeconomic background: Majority of carers and patients had above secondary education; half have a household income <RM1000
  • Inclusion criteria: Patients were well enough to be on follow-up in the community for long-term antipsychotic therapy. Carers also understood either Malay or English language
  • Exclusion criteria: Carers who had co-morbidity of substance abuse or having uncontrolled or unstable medical illness requiring admission, and those who had already undergone a structured psychoeducation programme


InterventionsStated purpose: Assess effectiveness of a structured psychoeducation programme in improving knowledge of carers, decreasing the carers' burden and reducing patient re-admission rates as well as the rate of default to follow-up

INTERVENTION 1:

Name: 5 module psychoeducation programme for carers

Delivered by:

  • Title/name of NSHW/OPHR and number: Health staff: medical assistants and staff nurses who were involved in the care of patients with schizophrenia
  • Selection: Those who spoke English or Malay
  • Educational background: Not specified
  • Training: Workshop for health assistants on how to do psychoeducation for carers. Done by psychiatrists, and psychoeducation team members. Consists of 5 modules: understanding the illness, treatment, prevention of relapse, handling crisis and health life, diet and exercise
  • Supervision: Supervised training done initially under care of specialist, after which the programme was carried out on their own. For the purpose of the study, fidelity testing was done to ensure compliance to the actual module
  • Incentives/remuneration: Information from author: "No incentives were given other than training"


Intervention details:

  • Duration/frequency: Delivered to carers over a period of 2 weeks
  • Content of intervention: Psychoeducation delivered by health staff using audiovisual aids (e.g. PowerPoint presentations), charts or booklets. Carers encouraged to participate actively and ask for clarifications


CONTROL: Carers in the control group received standard treatment that consisted of history taking for symptoms of relapse, noting concomitant complaints, prescribing medication and giving appointment for patients. No additional formal psychoeducation was given for either patient or family in this group

CO-INTERVENTIONS: Standard medical treatment


OutcomesPatient: DSM-IV: diagnosis*; default rates

Carer: Change in knowledge of carers § (pre-post test knowledge scores); change in carers burden (FBIS - which contains 5 sections: a. assistance in daily living: severity and burden; b. supervision: severity and burden; c. financial expenditure: severe debt, financial burden; d. impact on daily routine for past 1 month; e. worry

Process/health worker outcomes: Re-admission rates (relapse rates)

Economic outcomes: None (apart from measuring FBIS financial burden (as above)

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: Baseline, 3 months, 6 months for all outcomes, and in addition post-test scores for knowledge of carers


NotesSource of funding: National Institute of Health, Malaysia and the Perak State Health Department

Notes on validation of instruments (screening and outcomes): DSM-IV and FBIS validated (originals used, not translated)

Additional information (e.g. provide by authors, existence of a published study protocol): Not specified

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: None


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "Clinics were assigned to the intervention or control group allocation at the onset (three clinics each), and subjects were recruited in each clinic by convenient sampling. No randomisation was done within each clinic as researchers felt contamination bias could not be adequately addressed if both intervention and control subjects were recruited from the same clinic. Intervention clinic was chosen based on geographical accessibility to researchers"

Comment: Cluster sampling and convenience sampling, i.e. is not random so it is high risk

Allocation concealment (selection bias)High riskComment: No information about allocation concealment. there probably is none as it was not randomised

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Would not be possible to blind participants or personnel. Unlikely to affect outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: There are objective outcomes for patient (re-admission rate and defaulting from follow-up), which are reported for > 80% of people

Blinding of outcome assessment (detection bias)
subjective outcomes
High riskQuote: "Assessments were conducted by staff in the clinics, and hence not blinded to the group allocation status"

Baseline outcome measurements similarLow riskComment: All similar

Baseline characteristics similar?High riskQuote: "As the intervention and control group differed significantly in gender, household income and duration as a caregiver, all subsequent analysis was done within each group and not between groups"

Comment: The baseline characteristics are dissimilar so cannot compare the groups

Incomplete outcome data (attrition bias)
Efficacy data
Low riskQuote: "There were five dropouts: two were dropped due to pretest inadvertently missed in the recruitment period, one patient passed away due to dengue fever midway through the study, one caregiver developed stroke and was unable to care for the patient and one caregiver was unable to complete the study questionnaire as he was untraceable."

Comment: Only 5/109 dropouts (< 20%) so low risk of affecting outcome data

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskComment: There are defaulter rates and readmission/relapse rates reported

Protection against contaminationLow riskInformation from author: "To ensure no contamination, the intervention/control was carried out in different clinic populations with different staff involved and these clinics were also geographically physically separate. The control population were not exposed to the intervention module to our best knowledge"

Comment: In addition, control carers were on a waiting list so there may not have been that much curiosity to find out what was going on in intervention group

Reliable primary outcome measuresLow riskComment: No inter-rater reliability reported but low risk as validated tools

Selective reporting (reporting bias)Low riskComment: All outcomes mentioned in methods are reported in results. Not able to source protocol

Other biasLow riskComment: None detected

Patel 2010 C-RCT India

MethodsStudy design: RCT (cluster trial - unit allocation - health facility (PHC or GP), analysis - individual)

Duration of study: April 2007 to September 2009


ParticipantsCountry: India

Income classification: Lower-middle income country

Geographical scope: Urban and rural

Healthcare setting: PC facilities, i.e. all facilities with space and primary and privacy for LHCs regular outpatient clinics not involved in preliminary phases of the project. There were government PHC facilities and private GP settings

Mental health condition: Common mental disorders

Population: Patients

  • Age: > 17
  • Gender: Both
  • Socioeconomic background: Predominantly female, married and one-third widower, nearly half of them < 1 year of education or illiterate
  • Inclusion criteria: 1. Adults > 17 years , speaking Konkani, Marathi, Hindi, English, need not need medical attention, did not have difficulty with hearing, speaking, cognition, not already screened in the previous weeks, not receiving intervention. 2. Those who screened positive for common mental disorders with the GHQ-12; with a previously validated cut-off of > 5) and who expected to be resident of Goa for subsequent 12 months


  • Exclusion criteria: Had a cognitive or sensory impairment that made participation in the evaluation difficult. Not speaking Konkani, Marathi, Hindi or English


InterventionsStated purpose: The MANAS trial aimed to test the effectiveness of an intervention led by LHCs in PC settings to improve outcomes of people with these disorders

INTERVENTION:

Name: Collaborative stepped-care intervention - Phase 1 (12 government PHCs) and Phase 2 (12 private GP facilities)

Delivered by (NSHW or OPHR and title)

  • Title/name of NSHW/OPHR and number: 1. LHC; 2. GP and PHC physicians
  • Selection:LHC: A woman fluent in the local languages, have excellent communication skills and be available for consultations on a regular basis in the clinics; GP/PHC physician: those located at the selected facilities
  • Educational background:LHC: Graduates - locally recruited, graduate non-medical worker; GP/PHC physician: registered medical GP as per the a priori eligibility criteria
  • Training:LHC: Training component included how to deliver the various treatments, including counselling skills, psychoeducation, yoga and IPT. Their training was based on a draft manual developed for the intervention. Duration: 2 months' training. Trained by research team. GP/PHC physician: half a day of training and given a manual
  • Supervision: of LHCs and GPs/PHC physicians: Clinical specialist (psychiatrist) visited about once a month and was also available for consultation on the telephone to discuss cases
  • Incentives/remuneration: Not mentioned


Intervention details:

  • Duration/frequency: Both phases carried out consecutively between April 2007 and September 2009
  • Content of intervention: LHCs provided psychoeducation: Psychoeducation taught patients strategies to alleviate symptoms, such as breathing exercises for anxiety symptoms and scheduling activities for symptoms of depression. Encouraging adherence to treatments for these disorders and providing information about social and welfare organisations when needed were other key components of psychoeducation. Individual (not group) IPT was also provided by the LHC as the psychological treatment of choice. Focus on interpersonal problems such as grief, disputes and role transitions. A minimum of 6 sessions, with an optimum of 8 and a maximum of 12 sessions, was offered to each eligible participant. Interpersonal psychotherapy was reserved only for patients who had moderate or severe common mental disorders, and was offered as an alternative to, or in addition to, antidepressant drugs for those who did not respond to antidepressant treatment. Physician/GP roles: prescribe antidepressants according to a protocol for moderate to severe depression (private GPs could prescribe their drug of choice, PHC doctors had to use available drug). The other key roles of the physicians were to encourage patients to meet the LHC, to avoid the use of unnecessary drugs, and to provide usual care for any co-existing physical health problems. Referral: Referral to the clinical specialist was reserved for patients who were assessed as having a high suicide risk at any stage, were unresponsive to the earlier treatments, posed diagnostic dilemmas, had substantial co-morbidity with alcohol dependence, had other associated substantial medical problems, or for whom the PC physician requested a consultation


CONTROL: Enhanced usual care: physicians and patients in usual care practices received screening results and were given the treatment manual prepared for PC physicians. Physicians were allowed to start treatments of their choice

CO-INTERVENTIONS: None


OutcomesPatient: Screening: GHQ-12. Primary outcome: CIS-R*: generates 2 outputs: an ICD-10 diagnosis derived from a computer algorithm and a total score indicating the overall severity of symptoms

Carer: None

Process/health worker outcomes: None

Economic outcomes: None

(*: primary outcomes of the study)

Time points: Baseline 0 and follow-up 6 months, 12 months


NotesSource of funding: The MANAS project was funded by a Wellcome Trust Fellowship in clinical sciences

Notes on validation of instruments (screening and outcomes): Validated GHQ in Goan setting but not specified for the CIS-R

Additional information (e.g. provide by authors, existence of a published study protocol): Yes

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: NCT00446407


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote 1: "Facilities were stratified into three strata; urban with a visiting psychiatrist (VP), rural with a VP, rural without a VP. Two intervention and two control PHCs were selected at random from each stratum, using on-line software by the MANAS trial statistician (HW). A given seed number was used to enable the randomisation procedure to be reproduced. This guards against mis-allocation or changes in allocation at a later stage"

Quote 2: "For phase 1, 17 facilities in Goa met these inclusion criteria, of which 12 were randomly selected for inclusion in the trial. PHC facilities were first stratified by the presence or absence of a visiting psychiatrist and then randomised within four strata defined by size"

Quote 3: "12 of the 22 eligible GP facilities were randomly selected for phase 2 of the trial. The 12 GP facilities were randomised within two strata defined by size. For both phases, facilities were randomly allocated within each stratum to either the intervention or control arm using a 1:1 allocation ratio using a computer-generated randomisation sequence"

Allocation concealment (selection bias)Low riskQuote 1: "Randomly allocating unique patient IDs [identification number] so that there is no association between the ID number and the facility identity"

Quote 2: "Assessing the efficacy of blinding (through asking assessors to guess which arm the participant is allocated to) at the end of the trial"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: It was a cluster randomised trial but the non-blinding of participants was unlikely to affect the outcome

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskQuote: "Health assistant completes baseline CIS-R schedule"

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote 1: "Masking of the research assessor maximised by; undertaking assessment at home; randomly allocating clinic identification numbers to patients so that there was no association between their number and identity of the facility; outcome assessment by an independent association and undertaking primary outcome assessment before all assessment"

Quote 2: "Emphasizing to assessors that all patients are receiving an intervention (not specifying whether this is enhanced care or Collaborative Stepped Care) and that there is genuine equipoise about which is better. but also: health assistant completes baseline CIS-R schedule"

Baseline outcome measurements similarLow riskQuote 1: "We recorded little intra-cluster correlation (0.03), and the coefficient of variation (k) for prevalence of these disorders at baseline in all patients who screened positive was 0.08"

Quote 2: "Although participants in the enhanced usual care group were more likely to have depression, the proportion of patients with these disorders according to ICD-10 and mean CIS-R scores were similar"

Baseline characteristics similar?Low riskQuote 1: "Characteristics of patients differed by clinic type"

Quote 2: "Distribution of these disorders between groups was similar; although participants in the enhanced usual care group were more likely to have depression, the proportion of patients with these disorders according to ICD-10 and mean CISR scores were similar"

Comment: baseline characteristics were dissimilar but adjusted for in the analysis

Incomplete outcome data (attrition bias)
Efficacy data
Unclear riskQuote: "1160 participants (85%) in the collaborative stepped-care group and 1269 (88%) in the control group completed the 6-month outcome assessment"

Comment: Low risk at 6 months, but high risk at 12 months: significant difference in attrition between collaborative care and control groups (81% vs. 77%; P value = 0.01), which may not be clinically significant but nevertheless no stated reasons for this variation in dropout

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskQuote 1: "No stopping rules are proposed because serious adverse events are not expected in the trial since none of the treatments being offered are experimental or associated with serious outcomes"

Quote 2: "There were seven serious adverse events (three deaths and four suicide attempts) in the collaborative stepped- care group and 12 in the enhanced usual care group (six deaths and six suicide attempts). None of the deaths were from suicide"

Protection against contaminationLow riskQuote: "We do not anticipate a significant risk of contamination, i.e. patients moving from an Enhanced usual care control facility to an intervention facility, due to the geographical spread of facilities, and because no publicity will be produced regarding the availability of the intervention in other facilities"

Reliable primary outcome measuresLow riskQuote 1: "Process indicators assessing the fidelity and quality of the intervention were obtained from four sources: the separate clinical records maintained by the lay health counsellor and the clinical specialist, antidepressant use from the clinic records, and quality assessments done for every component of the intervention. Quality assessments for intervention components were made by direct observation or through transcripts of sessions, and were rated by senior clinicians. The only possible process indicator in the enhanced usual care group was antidepressant use"

Quote 2: "From results it seems like those who needed antidepressants got them, but those who were on IPT - most completed first session (95-98%) but v [very] few completed the required minimal standard of 6 sessions (PHC: 33%; GP: 0%). As the intervention was not effectively delivered for psychotherapy it may be difficult to assess the outcomes in those receiving it (i.e. those with mild to moderate symptoms)"

Selective reporting (reporting bias)Low riskComment: No selective reporting

Other biasLow riskComment: No other bias detected

Rahman 2008 CRCT Pakistan

MethodsStudy design: Cluster RCT single-blind study with 2 parallel groups (Unit of allocation - union council clusters, unit of analysis - individual)

Duration of study: Enrollment between April 2005 and March 2006


ParticipantsCountry: Pakistan

Income classification: Low-income country

Geographical scope: Rural area of Pakistan where there was subsistence farming

Healthcare setting: Home

Mental health condition: Antenatal depression in 3rd trimester

Population:

  • Age:16-45 years
  • Gender: Female
  • Socioeconomic background: 68% of the cases and controls were poor; nearly 40% of them relying on well without pump; 55% relied on the field for toilets and "subsistence farming, supplemented by one or more of the men serving in the armed forces or working as government employees, or as semi-skilled or unskilled labourers in the cities". "Male and female literacy rates are 79.6% and 48.6% respectively". "Infant mortality rates are 84 per 1000 live births"
  • Inclusion criteria: Participants were women in the 40 Union Councils who were aged 16-45 years, married, and in their third trimester of pregnancy. They were enrolled from lists of participants compiled from official registers kept with the Lady Health Workers
  • Exclusion criteria: Women with a diagnosed serious medical condition requiring inpatient or outpatient treatment, pregnancy-related illness (except for common conditions, such as anaemia), substantial physical or learning disability, and postpartum or other form of psychosis


InterventionsStated purpose: To develop and deliver a psychological intervention to depressed mothers and their infants through non-specialist village-based health workers

INTERVENTION:

Name: Thinking healthy programme

Delivered by

  • Title/name of NSHW/OPHR and number: 40 Lady Health Workers
  • Selection: Existing staff in the union councils were trained to deliver the intervention
  • Educational background: Completed secondary schools
  • Training: 2-day workshop and 1-day refresher 3 months after the first training was all given by the study team psychiatrist. Here and now problem-solving CBT was used with a manual that used culturally appropriate illustrations. Included in the training were the 3 steps that helped in avoiding direct confrontation with the mothers and manage illiterate mothers
  • Supervision: Research team meetings in which "health workers brainstorm for solutions and discuss their successes and failures in a supportive environment"
  • Incentives/remuneration: Not mentioned


Intervention details:

  • Duration/frequency: Session every week for 4 weeks in the last month of pregnancy, 3 sessions in the first postnatal month and nine 1 monthly sessions thereafter
  • Content of intervention: 3-step approach: 1. identify unhealthy unhelpful thinking styles and behaviours, 2. replacing these with helpful or healthy thinking; 3. activities and 'homework' to help mothers practice healthy thinking


CONTROL: Enhanced usual care: "control clusters received an equal number of visits in exactly the same way as those in the intervention group, but by routinely trained Lady Health Workers (two for each Union Council)"

CO-INTERVENTIONS: None


OutcomesPatient: Infant weight and height at 6 and 12 months *§, maternal depression, exclusive breastfeeding §, number of diarrhoeal episodes in the infants in the 2 weeks before interview §, records of immunisation § (with or without up-to-date immunisation status), use of contraception § and if both parents set aside time every day to play with their infant §

Carer (mother): Structured clinical interview for DSM IV diagnosis (screening); HDRS (for outcomes); brief disability questionnaire §; global assessment of functioning questionnaire; multidimensional scale for perceived social support §

Process/health worker outcomes: None

Economic outcomes: None

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: Baseline, 6 and 12 months


NotesSource of funding: This research was funded by a career development fellowship awarded to Atif Rahman by the Wellcome Trust, UK

Notes on validation of instruments (screening and outcomes): Structured clinical interview for DSM IV diagnosis and HDRS are internationally validated, but not specified if validated for the Pakistani settings. Other mother outcome scales not validated. Child outcome tools validated

Additional information (e.g. provide by authors, existence of a published study protocol): Study protocol is not present

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: ISRCTN65316374


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "40 Union Councils in the two subdistricts of the study area. These subdistricts were geographically contiguous and ethnically, culturally, and socio-economically homogeneous. All the units were eligible for randomisation, which was done by an independent trial centre in Islamabad, before recruitment of participants. These administrative units were assigned by random allocation with a table of random numbers by a researcher who was not involved in the study and who was unaware of the identity of the Union Councils. Lady Health Workers from each Union Council were enrolled to participate in the study before randomisation"

Comment: Adequate

Allocation concealment (selection bias)Low riskQuote: "The interviewers were unaware of the allocation status of the Union Councils (because they had no contact with the team that did the randomisation), and we took care to ensure they remained so; none of the interviewers resided in the study area, and throughout the duration of the study they had no contact with the Lady Health Workers or any other health personnel in the study area. Mothers were asked not to tell the interviewers anything about their sessions with Lady Health Workers"

Comment: Adequate

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Mothers in the control clusters received an equal number of visits in exactly the same way as those in the intervention group, but by routinely trained Lady Health Workers (two for each Union Council). These health workers in both groups received monthly supervision, and were monitored by the research team to ensure that they were attending the scheduled visits. In practice, the Lady Health Workers seldom provide such structured and monitored care in the community. The control group thus received what would be regarded as ideal care, which we called enhanced routine care"

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskQuote: "All infant outcomes were assessed by researchers unaware of the psychiatric status of the mother"

Comment: > 80% subjects and deemed low risk

Blinding of outcome assessment (detection bias)
subjective outcomes
Unclear riskQuote: "The interviewers were unaware of the allocation status of the Union Councils (because they had no contact with the team that did the randomisation), and we took care to ensure they remained so; none of the interviewers resided in the study area, and throughout the duration of the study they had no contact with the Lady Health Workers or any other health personnel in the study area. Mothers were asked not to tell the interviewers anything about their sessions with Lady Health Workers"

Comment: Likely low risk, though a small risk that mothers may have told aspects of their interactions with LHWs to interviewers

Baseline outcome measurements similarLow riskComment: All similar

Baseline characteristics similar?Low riskComment: All similar

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: All outcomes stated they would collect, are reported

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: None mentioned

Protection against contaminationLow riskQuote: "Normally one Basic Health Unit provides primary health care for one Union Council and all affiliated Lady Health Workers work in villages within that Union Council only. Supervision of health workers takes place in the Union Council. Thus the risk of contamination of the control group with the intervention is negligible"

Reliable primary outcome measuresLow riskQuote: "Growth data were converted into SDs (Z scores) for weight and length with Epi Info 2002 (version 3.4.1)"

Selective reporting (reporting bias)Low riskComment: No selective reporting

Other biasLow riskComment: No other obvious sources of bias

Rojas 2007 RCT Chile

MethodsStudy design: Single-blind parallel RCT

Duration of study: June 2004 to 2006


ParticipantsCountry: Chile

Income classification: Upper middle income

Geographical scope: Urban-deprived urban area of Santiago

Healthcare setting: 3 PHC clinics

Mental health condition: Postnatal depression

Population: Women

  • Age: mean (SD) 26.7 (SD 6.4)
  • Gender: Female
  • Socioeconomic background: Low-income women and majority were housewives
  • Inclusion criteria: Scoring ≥ 10 on EPDS at 2-week intervals and ≥ 18 years women with children younger than 1-year of age and who meet DSM-IV criteria for major depression
  • Exclusion criteria: Women who received treatment for depression during their current postnatal period if they were pregnant, psychotic symptoms, serious suicide risks, history of mania, alcohol or drug abuse


InterventionsStated purpose: Compared the effectiveness of a multicomponent intervention with usual care to treat postnatal depression in low-income mothers in primary care clinics in Santiago, Chile (protocol mentioned they would look at infant outcomes. There are no infant outcomes mentioned in the protocol or have they been reported in the results paper)

INTERVENTION:

Name: Multicomponent intervention

Delivered by

  • Title/name of NSHW/OPHR and number: Physician doctor, group leaders (midwives) and nurse, and a designated trained non-professional person
  • Selection: Doctor - from the PHC selected, group leaders and non-professionals - not specified
  • Educational background: Doctor - medical degree, group leaders and non-professionals - not specified
  • Training: Group leaders - 8 hours of training. Non-professional - not specified
  • Supervision: Doctor - 1 hour of supervision every week by research psychiatrist, group leaders - supervision every week by the doctor and the non-professionals - not specified
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: The group sessions consisted of 1 session per week for 8 weeks (maximum 20 attendants with every session lasting 50 minutes). Women received medical appointments at 2 and 4 weeks and subsequently every month for the first 6 months
  • Content of intervention (by types of health worker and per patient/carers;doctor: Protocol: First choice of drug was fluoxetine (20-40 mg/day) but sertraline (50-100 mg/day) was also available for those who did not respond to fluoxetine or were breastfeeding. All medication was supplied free in both groups. Group leaders: Psychoeducation intervention, which consisted of information about symptoms and treatments, problem solving and simple behavioural activation, and cognitive techniques. All topics were presented with examples relevant to the postnatal period. Groups consisted of 1 session per week for 8 weeks (maximum 20 attendants), with every session lasting 50 minutes. The groups followed a structured format with every session covering something different but with plenty of time for sharing experiences. There was poor attendance of these psychoeducational sessions: "mean number of multicomponent intervention group sessions attended was 2·7 of eight (SD 3·1), and attendance was not associated with the EPDS score", "women taking medication attended slightly more sessions". Group leaders: they delivered the sessions but had no further contact with patients. Doctor was ultimately responsible for the group, non-professional: designated trained, non-professional person monitored attendance at consultations and group sessions and provided support and advice about antidepressant use following a structured format. If any problems were detected, patients were advised to see their doctors and some assistance was provided to obtain medical appointments sooner if deemed essential


CONTROL: Usual care: "Usual care included all services normally available in the clinics, including antidepressant drugs, brief psychotherapeutic interventions, medical consultations, or external referral for specialty treatment. Although all these options are potentially part of usual care, in reality medication and consultation remain the main treatment methods; psychotherapy and specialty referrals are rarely offered. Doctors in the usual care group were informed of the baseline assessment but no further information was provided"

CO-INTERVENTIONS: None


OutcomesPatient: EPDS* - used twice for screening (2 weeks apart), MINI (used to establish inclusion and exclusion criteria in people screened twice, SF-36 - secondary outcome (has 4 dimensions - mental health, social functioning, emotional role and vitality)

Carer: n/a

Process/health worker outcomes: No process

Economic outcomes: None

(*: primary outcomes of the study)

Time points: Baseline, 3 and 6 months


NotesSource of funding: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Notes on validation of instruments (screening and outcomes): All are validated but not specified if the EPDS and MINI were translated/validated in that setting

Additional information (e.g. provide by authors, existence of a published study protocol):None

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: NCT00518830


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote from the paper: "The clinics participating in the trial were chosen for practical reasons rather than randomly selected, which could affect the generalisability of our findings"

Comment: 1. But these are deemed fairly representative of PHCs in deprived urban areas in Santiago;

2. The number were computer generated random numbers,

therefore, low risk of bias

Allocation concealment (selection bias)Low riskQuote: "Allocations were kept in numbered sealed envelopes in every clinic, opened by a person"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Neither control nor intervention groups were blinded for the intervention. The usual care group could receive medical consultation and so differential intervention were unlikely

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes used

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote: "Staff recruiting patients were neither involved in nor aware of the procedure used to generate allocations"

Baseline outcome measurements similarLow riskComment: Yes, baseline outcome measurement similar

Baseline characteristics similar?Low riskComment: Yes: all were similar

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: 90% of women randomly assigned, completed their 6-month assessment in both groups but not adjusted for in analysis

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No information on safety data

Protection against contaminationLow riskQuote: "Since women in both groups attended the same centres, some degree of contamination could possibly have occurred, but we tried to reduce this possibility by allocating patients in each group to different doctors. Our previous experience with clinical trials in these settings shows that after a few weeks, the pressure of work is so intense that participating clinicians only remember things when constantly reminded. If there were contamination it would have been more likely in early stages of the study, which is when we found the largest differences, than in late stages"

Comment: Though there is no wait-list control, they have tried to minimise contamination by allocating patients to different doctors. Unlikely to be that much contamination

Reliable primary outcome measuresLow riskComment: Validated tools were used and were shown to be reliable in other studies including previous RCT (Araya 2003) 

Selective reporting (reporting bias)Low riskComment: The trial prospectively registered. All pre-stated outcomes reported

Other biasLow riskComment: No other bias

Scholte 2011 CBA Rwanda

MethodsStudy design: CBA study

Duration of study: This study took place from October 2007 to September 2008, preceded by a pilot study over 2005-2006


ParticipantsCountry: Rwanda

Income classification: Low-income

Geographical scope: Rural, Gicumbi district in northern Rwanda, post-genocide population

Healthcare setting: Community groups: sociotherapy groups were set up in the community after individuals enrolled in the programme

Mental health condition: Mental health outcomes post-war; high mean SRQ-20 scores in entire group at baseline; study also separately examines the 63% females and 37% males scoring above cut-off at baseline for common mental disorders (include depression and anxiety)

Population: Patient

  • Age: ≥ 16 years ; mean age 34.9 (range 16-76 years) intervention: mean age 38.5 years (range 16-73 years) control These values were for entire sample, rather than subset meeting cut-off at baseline
  • Gender: Both
  • Socioeconomic background: SES determined differently for control and intervention groups, interviewers scored SES by judging the state of the houses in person, intervention group: interviewed at the spot of their meetings and asked to describe the state of their houses themselves; placed into groups of marginal (6% intervention vs. 13% control), poor (83% intervention vs. 66% control), and sufficient (11% intervention vs. 21% control), similar education characteristics (50% had no schooling) This was in entire sample, rather than the subset meeting cut-off at baseline
  • Inclusion criteria: From protocol: 1. Within a 6-year period all areas of Byumba province were covered by the sociotherapy programme. The sequence of areas was dictated by matters of actual convenience, and determined by the programme's local counterpart; 2. Group participants were aged ≥ 16 years; 3. The composition of groups was mixed (both sexes, various ethnic backgrounds, wide age distribution); no strict criteria for participation in a sociotherapy group existed
  • Exclusion criteria: No exclusion criteria. Purposeful decision as people are paranoid there and would not open up before being within a group therapy session


InterventionsStated purpose: Aims to establish the effects of a therapeutic group intervention called sociotherapy, which is specifically tailored to traumatised survivors of systematic violence displaying a broad spectrum of affective and cognitive disturbances

INTERVENTION: Sociotherapy programme

Delivered by:

  • Title/name of NSHW/OPHR and number: Trained Rwandan community leaders, number not specified
  • Selection: Local people
  • Educational background: Familiar with region's history and current living situation
  • Training: 3 months of training from Equator (Dutch agency) staff
  • Supervision: "Regularly supervised" by Equator staff
  • Incentives/remuneration: No fees, travel expenses reimbursed


Intervention details: Group therapy

  • Duration/frequency: 10-15 people in each group, 45 groups total, weekly meetings over 15 weeks, lasting 3 hours each
  • Content of intervention: "The technique therapeutically uses interaction between individuals and their social environment to help subjects to reassess and re-define values, norms, relations and possible collaborations. The principal premise is that reaching a certain level of mutual respect, trust and care in group interaction helps to increase the problem solving capacity and subjective mental health in individual group participants....In non-clinical, international settings it is essential to continuously tailor it to the actual context and group (so the intervention is not strictly protocolised). Group leaders are allowed to attune their routines to the characteristics of their groups (e.g., degree of trust, nature of problems) and to their own affinity and experience, putting different emphases on elements like rules, role plays, and spirituality. For example, group leaders who are pastors may stimulate praying and singing, while teachers may encourage role plays and debate about social rules; others again may take a less active role, supporting the group to share experiences. There were some core principles, however, that all group leaders complied to: two-way communication, shared leadership, consensus in decision-making, and social learning through actual social interaction. Additionally, each subsequent phase of a group had a different focus, notably safety, trust, care, respect, rules and memories"


CONTROL: Selection of controls: to ensure equivalence at baseline with regard to SRQ-20 score, the following was done. "We identified five regions within Gicumbi district where the programme was not or had not been running so far, or for practical reasons would not start over the upcoming year. It could be assumed the inhabitants of these regions had experienced similar trauma exposure. Here, we randomly selected respondents through convenience sampling. Interviewers started at the top of a hill or in the centre of a village and each walked down a different footpath towards scattered houses or huts. An equal number of men and women, at home or in the fields, were randomly chosen and asked to participate. Finally 251 respondents were interviewed. After analysis of the data collected, we selected a group of 100 out of these for which the distribution of SRQ-20 scores matched that of the intervention group. For this purpose we used 8 clusters of scores (0-1, 2-3, 4-5, 6-7, 8-9, 10-12, 13-15, 16-20) and from each cluster randomly selected a number of respondents equal to the corresponding cluster in the experimental group. This final selection of 100 constituted our definite control group"

CO-INTERVENTIONS: None


OutcomesPatient: SRQ-20 for common mental disorders

Carer: n/a

Process/health worker outcomes: Not assessed

Economic outcomes: None

Time points: Measurements were taken pre and post intervention and at 8 months' follow-up


NotesSource of funding: Partly by grant from Health Research Development Counsel, Department Prevention Programme (ZonMW), OOG- Geestkracht (ZonMW: 60-60105-98-117), partly by Cordaid and partly by a Prins Bernhard Cultuurfonds grant 

Notes on validation of instruments: WHO developed questionnaire, translated and back translated for the study, "Reliability was considered to be good (Cronbach's a=0.83). The optimal cut-off point was 7/8 for men and 9/10 for women (manuscript under review). We also validated the SRQ-20 for its capacity to assess change in symptom severity over time. The instruments factor structure proved to be time invariant; the number of factors, factor loadings and covariances of factors remained equal over time"

Additional information: www.trialregister.nl/trialreg/admin/rctview.asp?TC=1120

Handling the data (e.g. imputed values/other calculations we have made): None

Prospective trial registration number: Nederlands Trial Register 1120


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskComment: CBA study; after enrolling participants with interest or referral to the intervention, 45 groups created (number not specified), 10 groups selected out of convenience balanced by gender and ratio, 100 were randomly selected from 133 total participants in the 10 groups, controls were matched with the 100 based on SRQ-20 score, gender and age

Allocation concealment (selection bias)High riskComment: CBA study

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Personnel conducting intervention were not blinded, neither were participants. This is unlikely to affect outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskComment: Personnel conducting interviews were not blinded as to control or intervention group but self report outcomes from patient

Baseline outcome measurements similarLow riskComment: Participants were matched for outcome measure so no group differences observed (P value = 0.83)

Baseline characteristics similar?Unclear riskComment: SES was significantly different between groups. This applied to entire sample only (not just those whom we report, i.e. those who are probable cases). Unclear for this group whether any group differences

Incomplete outcome data (attrition bias)
Efficacy data
Unclear riskComment: Loss to follow-up similar in intervention and control (19 of 100 in intervention vs 27 of 100 in control); however, control group follow-up was below 80%, therefore, high risk

This applies to entire sample only. As above

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskComment: No adverse outcomes observed

Protection against contaminationLow riskComment: Control group were selected from 5 regions where programme was not running and would not start for the upcoming year

Reliable primary outcome measuresUnclear riskComment: No kappas given

Selective reporting (reporting bias)Unclear riskComment: In the protocol, it mentioned several secondary outcomes that were not reported (social functioning, as measured by the Byumba Social Functioning Questionnaire. Social functioning will also be measured with the MOS Social Functioning Scale 36 items (SF-36); Social capital, as measured by use of the SA-SCAT. Alcohol use, as measured by use of the AUDIT-C. IPV, as measured by using elements of the CTS2S: the 'negotiation', 'psychological aggression', 'physical assault' and 'injury' scales

Other biasLow riskComment: None detected

Shin 2009 RCT Vietnam

MethodsStudy design : RCT

Duration of study: Not specified


ParticipantsCountry: Vietnam

Income classification: Lower-middle

Geographical scope: Urban, Hue is a major city in central Vietnam

Healthcare setting: Home

Mental health condition: Children with intellectual disability

Population: Mother/child with intellectual disability dyads

  • Age: Children aged 3-6 years; mothers mean age (SD): 36.2 years (6.7)
  • Gender: Both
  • Socioeconomic background: Majority of participants rated low average and average economic status (as observed by interviewer based on housing conditions), majority had high-school education or more, control more high-school educated and intervention group more junior college participants
  • Inclusion criteria: 3-6 year olds with IDs identified by teachers in kindergarten programmes or by records of community health clinics
  • Exclusion criteria: Severe physical disability (such as microcephaly or severe physical disability too severe to receive intervention services)


InterventionsStated purpose: This study was conducted to examine the impact of a 1-year intervention for children with ID in Vietnam

INTERVENTION 1:

Name: Portage curriculum for preschool children

Delivered by:

  • Title/name of NSHW/OPHR and number: 11 teachers
  • Selection: Recruited from primary special education schools
  • Educational background: 4 years of experience with children with intellectual/developmental disabilities
  • Training (contents, duration and by whom): 3 months of weekly training on Portage Program curriculum before intervention, monthly review sessions after intervention
  • Supervision: Random visits by experienced supervisors; also monitoring done by parent who signed weekly sheets to testify of the teacher's visit
  • Incentives/remuneration: Weekly payment upon receiving signed teaching objective from intervention session


Intervention details:

  • Duration/frequency: Weekly 1-hour sessions over 1 year
  • Content of intervention: "Typically teachers hold a 1-h session each week, which can be broken down into three small components. First, they review the homework assignment by having the parents demonstrate the previously assigned homework with their children. Second, teachers review one or two new teaching objectives they wrote with the parents and demonstrate the steps to achieve a desired behaviour by demonstrating the objectives. These new objectives become the newly assigned homework for the parents, who try them with their children and receive coaching and feedback on their work. Assurance of parent compliance in carrying out the programme was made by teachers, who reviewed the daily homework checklist parents completed and who observed parents demonstrating their work with their children during their next visit"


CONTROL: Usual care (wait-list control). Peers who attended the kindergarten with no added parental training

CO-INTERVENTIONS: None


OutcomesPatient: 1984 VABS

Carer: Not assessed

Process/health worker outcomes: Not assessed

Economic outcomes: None

Time points: Baseline, 6 months, 12 months


NotesSource of funding: Partially supported by funding from KFR-2005-J01702 in Korea and a travel grant by the Center for International Rehabilitation and Research Information Exchange in the US

Notes on validation of instruments: Screening and outcome instruments the same, VABS evaluated for content and semantic equivalence by 3 bilingual Vietnamese, "The Cronbach alpha values of the scale over three assessments are 0.94 to 0.96 for the communication, 0.95 to 0.97 for the daily living skills, 0.91to 0.95 for socialisation and 0.95 to 0.97 for motor skills. The validity of the Vietnamese Vineland version was assessed in another study with children with typical development" (Goldberg 2009)

Additional information: Protocol not available online

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: KFR-2005-J01702


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "After matching on gender, they (participants) were randomly assigned"

Author response: Done by coin toss randomisation

Comment: Minimal risk as there are so few people that are not randomised that it would not make significant difference

Allocation concealment (selection bias)Unclear riskComment: Authors swapped 1 mother that was randomised to the wait-list control group for 1 mother randomised to the intervention group. This would reveal allocation for that 1 person and the sample size is small (37 participants). This may affect the outcome

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Not possible to blind participants and personnel to the intervention. Unlikely to affect the outcome

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
High riskComment: Assessment of outcomes made through interviews with mothers conducted by teachers who already knew children

Baseline outcome measurements similarLow riskQuote: "No significant differences between the intervention and control groups in any of the domains of adaptive behaviour measured by the Vineland"

Baseline characteristics similar?Low riskComment: Intervention and control similar in child disability categories, age, gender, mother education and SES; children who stayed home compared with those in kindergarten had lower adaptive functioning but 1. not statistically significant and 2. taken into account during post hoc analysis

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: Number at each follow-up for both groups the same throughout the study follow-up periods, 16 in intervention and 14 in control

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No adverse outcomes reported

Protection against contaminationLow riskComment: Individual home visits to families by teachers, unlikely that contamination occurred, control families were to receive intervention eventually (wait-list controls)

Reliable primary outcome measuresLow riskComment: Author does not specify kappa agreement values, JP emailed to request clarification and kappa values were not done. However, the tool has been validated (see notes above)

Selective reporting (reporting bias)Low riskComment: All outcome scores on VABS reported 

Other biasLow riskComment: No other bias detected

Sutcliffe2009RCT Thailand

MethodsStudy design: RCT

Duration of study: 12 month trial between April 2005 to June 2006


ParticipantsCountry: Thailand

Income classification: Upper-middle income country

Geographical scope: Both urban and rural in Chiang Mai district, Northern Thailand

Healthcare setting: In the community, done in 'unmarked building', which was a drug treatment centre

Mental health condition: Methamphetamine use

Population: Adults, initial index participants recruited who then also brought in 'network' participants

  • Age: 18-25 years old (median 19 years (interquartile range: 18-20))
  • Gender: Both male and females (75% male)
  • Socioeconomic background: About a one-third worked, one-third students, one-third unemployed; primarily Buddhist (97.1%), and ethnically Thai (99.2%). A majority (63.8%) reported living with their parents. Participants' education level was low, with only 39% reporting being currently in school and a median of 9 (interquartile range: 9-11) years of schooling)
  • Inclusion criteria: Index participants: between the ages of 18 and 25 years at screening, used methamphetamine at least 3 times and had sex at least 3 times in the past 3 months, and were able to enrol at least 1 of their sex or drug network members in the study within 45 days of screening). Network participants: between the ages of 18 and 25 years at screening and had used methamphetamine at least 3 times or had sex with the index participant at least 3 times in the last 3 months
  • Exclusion criteria: Refused to have blood drawn or provide urine, if they were enrolled in another prevention study, or if they refused to provide locator information


InterventionsStated purpose: To compare the efficacy of a peer educator, network-oriented intervention ("peer education" condition) with a best practice standard life skills curriculum ("life-skills" condition) on methamphetamine use, sexual risks and incident STIs

INTERVENTION 1:

Name: Peer education condition

Delivered by:

  • Title/name of NSHW/OPHR and number: 6 peer educators
  • Selection: 2 facilitators with 1 back up (totalling 6 facilitators) who were in their early 20s and had been a part of the ethnography team in the study's first phase
  • Educational background: Not specified
  • Training: Facilitators were trained by the study's first and third authors in an intensive one-week long training session. The curriculum was being implemented using a manual. Copies of the manuals for the peer education and life skills conditions are available in Thai and English from the study authors


  • Supervision: Not specified
  • Incentives/remuneration: Not specified


Intervention details: (according to NSHWs/OPHRs and whether aimed at carers or patients (or both))

  • Duration/frequency: Seven 2-hour session for each group undertaken by the facilitators over 1 month with twice-weekly sessions. Participants in the peer education condition also attended 2 booster sessions that occurred 3 and 6 months after study entry
  • Content of intervention: "Peer education condition was based on theory, informed by an extensive 18-month formative research phase, and built upon our previous intervention experience in Thailand and USA." "The peer education condition aimed to teach participants to think critically about and reduce their methamphetamine use and sexual risk behaviours. Participants were taught communication skills that they practiced in role plays during the sessions and used to convey methamphetamine and risk reduction messages to specific social network members that were identified through a social network inventory administered at baseline. The first session aimed to build group cohesion and identity, through having the group establish its own "group rules" to follow during the ensuing sessions. During this session, participants delineated how methamphetamine affected themselves, their social network, and their family. The second session focused on social influences in initiating methamphetamine use and taught participants a set of communication tools that were reinforced and used throughout the subsequent sessions in designated role plays and videos. The third and fourth sessions focused on sexual risk reduction, sexually transmitted infections (STIs), and communication skills in sexual situations. The fifth session focused on stigma and examined methamphetamine's effects on participants' families and the broader community. Because of the intervention's focus on creating a positive and constructive role for participants, the sixth session was dedicated to participants being involved in a community service project, which was chosen by each group. These projects lasted two to four hours and included painting or cleaning temples, garbage clean-up in villages, renovating a village play ground, and weeding a community garden. During the seventh and final session, participants reviewed the content from the previous sessions and graduated from the project. Sessions were comprised of interactive teaching modules, instructive games, and problem-solving activities. Sessions ended with assigning peer education homework in which participants would discuss a specific issue with specific peers (MA-using and/or sexual partners), which were reviewed at the beginning of the next session"


CONTROL: A best practice intervention: a life skills building approach based on a skills building approach. "It was largely derived from cognitive behavioral psychology, which is widely used with youth in drug treatment and juvenile justice settings in Thailand. Juvenile justice staff were consulted throughout the development of the life skills condition. The sessions focused on the causes and consequences of methamphetamine use at the individual level, with specific attention to stress in the role of drug use. 1 session focused on STIs and sex risk behaviours. The sessions placed no emphasis on communicating the session content to social network members. The first session focused on examining the role of methamphetamine in participants' life. The second session reviewed problem-solving tools and friendships. The third session focused on the physiological effects of methamphetamine use. The fourth session addressed STIs and safer sex practices. The fifth session considered stress and coping. The sixth session focused on managing emotions and self worth. The last session reviewed the intervention and participants graduated"

CO-INTERVENTIONS: Prevention of STIs as part of what the peer educator sessions comprised


OutcomesPatient: 2 behavioural outcomes and 1 biological outcome: 1. Methamphetamine use during the 3 months prior to the interview*; 2. Use of condom for either vaginal or anal sex * §; 3. Presence of a laboratory-confirmed STI* §. In German (2012) the main outcome is depression scores (using CES-D scale)

Carer: None

Process/health worker outcomes: Not mentioned

Economic outcomes: Not mentioned

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: Baseline, 3 months, 6 months, 9 months and 12 months


NotesSource of funding: National Institutes of Health (1 R01 DA14702)

Notes on validation of instruments (screening and outcomes): No screening instruments used. "Methods to enhance the reliability of self-reported behaviours included: 1) using unique study ID's to maintain confidentiality during data collection; and 2) using a brief recall period (three months and 30 days). In addition, STI testing at the 12 month visit provided a biological outcome measure". CES-D validated in Thai setting (Trangkasombat and Nukhew 1998) with a cut-off score of 22 (range 0-60)

Additional information (e.g. provide by authors, existence of a published study protocol): None

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: Registration not mentioned


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "Nonrandom sampling recruitment methods". "Some risk of sampling bias due to recruitment time periods and locations'"

Quote: "Randomization of index members occurred at the end of the baseline visit. Indexes were randomised to either the peer education or the life skills condition within 45 days of their baseline visit. Randomization occurred in blocks (cohorts) once a minimum of 16 and a maximum of 24 index participants had been enrolled, and randomisation sequences for each cohort were generated by a computer program. Scheduling for the first session occurred within two weeks of randomisation. In total, 21 cohorts were randomised over a period of 15 months. As this was a peer network intervention and we were interested in examining the effects of index participants on their network members' risk behaviours, network members were not randomised to attend the peer education or life skills sessions. Their involvement was limited to the baseline and four follow-up visit assessments"

Allocation concealment (selection bias)Unclear riskQuote: Randomisation of index members occurred at the end of the baseline visit. Indexes were randomised to either the peer education or the life skills condition within 45 days of their baseline visit. Randomisation occurred in blocks (cohorts) once a minimum of 16 and a maximum of 24 index participants had been enrolled, and randomisation sequences for each cohort were generated by a computer programme

Comment: Allocation of randomisation in blocks. Not mentioned if this was in sealed envelopes, etc.; among those excluded (as found in CONSORT diagram 6 were randomised but attended the wrong arm of the trial

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Participants and personnel not blinded to intervention. This is unlikely to affect outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: Only biological tests for STIs not for methamphetamines

Blinding of outcome assessment (detection bias)
subjective outcomes
High riskQuote: "Behavioral data were collected through self-report and it is possible that social desirability influenced participants' responses, particularly in light of the recent 'war on drugs'"

Quote 2: "Interviewers were blind to the participant's group allocation"

Comment: Behavioural data self reporting is likely to bias the outcome assessment

Baseline outcome measurements similarHigh riskQuote: "There were few significant differences in demographic or reported drug use patterns between participants randomised to the peer education compared to the life skills condition. A significantly higher percentage of participants in the peer education condition compared to those in the life skills condition reported drinking problems (77% vs. 71%, p<0.05), condom use at last vaginal sex act (38% vs. 31%, p<0.05) and "always" using condoms in the past 30 days (22% vs. 16%, p<0.05)"

Baseline characteristics similar?High riskQuote: "There were few significant differences in demographic or reported drug use patterns between participants randomised to the peer education compared to the life skills condition. A significantly higher percentage of participants in the peer education condition compared to those in the life skills condition reported drinking problems (77% vs. 71%, p<0.05)"

Comment: Socio-demographic details similar but differences in drinking problems

Incomplete outcome data (attrition bias)
Efficacy data
Low riskQuote: "At each of the four follow-up visits, follow-up was greater or equal to 90% (range: 89% – 95%) for index participants and 86% (range: 85% – 91%) for network participants in both arms. Among index and network members in both arms, there was at least an 89% retention rate at the 12-month follow-up"

Comment: Mean 10% dropout (11% in intervention group, 9% in control group) reported but reasons not specified; however, low dropout rate so unlikely to affect outcomes

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: Not mentioned

Protection against contaminationHigh riskQuote: "There is the possibility that tight social networks were randomised to both control and intervention arms, leading to a high degree of contamination that resulted in a bias towards the null"

Quote 2: "It is highly probable that contamination occurred between the two study arms. Based on our observation at the study house, many participants enrolled in the study with or were referred to the study by their friends who could have been randomized to different study arms"

Reliable primary outcome measuresHigh riskQuote: "Behavioral data were collected through self-report and it is possible that social desirability influenced participants' responses, particularly in light of the recent 'war on drugs' "

Comment: Behavioural data self reporting is likely to bias the reliability of outcomes

Selective reporting (reporting bias)Unclear riskComment: All stated outcomes reported. No protocol to check if pre-specified outcomes are reported

Other biasHigh riskQuote: "Session attendance and follow-up rates were consistently high in both arms indicating a high level of interest; 'perhaps the comparison arm was too similar to the intervention with its parallel, albeit not as intense'; resulted in the arrest and forced treatment of thousands of drug users, as well as the extrajudicial killings of over 2500 people. In this context, it was difficult not to provide a comparison condition that was meaningful to the study participants and that provided them with important risk reduction information delivered in a humane and respectful manner"

Comment: The intervention and comparisons were too similar

Thabet 2005 CBA Palestine

MethodsStudy design: CBA study

Duration of study: Not specified, but conducted over 6 months during ongoing war


ParticipantsCountry: Palestinian territories (Gaza Strip)

Income classification: Lower-middle

Geographical scope: Urban and rural in North Gaza and mid-zone, study population from 6 refugee camps (1 camp with teacher education could not be assessed because of road closure)

Healthcare setting: Schools

Mental health condition: PTSD

Population: children

  • Age: 9-15 years
  • Gender: Both
  • Socioeconomic background: Large family size, low SES
  • Inclusion criteria: Selected from an earlier epidemiological study, attending UNRWA schools for refugees, and they had moderate to severe PTSD reactions at time of survey (even if PTSD scores had reduced to 'mild' range by the time of intervention
  • Exclusion criteria: Not mentioned


InterventionsStated purpose: Evaluate the short-term impact of a group crisis intervention for children living in a zone of ongoing war conflict

INTERVENTION 1:

Name: Crisis intervention

Delivered by

  • Title/name of NSHW/OPHR and number: Social worker (and psychologist as a specialist) both acting as facilitators
  • Selection: Not specified
  • Educational background: Not specified
  • Training: No training, but moderation by lead psychiatrist
  • Supervision: By lead child psychiatrist
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: 7 weekly sessions
  • Content of intervention: Debriefing and cognitive techniques for children. Adjusted to the nature of trauma (ongoing political conflict), sociocultural circumstances, and children's developmental ability, by using free drawing, talking about their traumatic experiences and feelings, writing about traumatic events, storytelling, games, and role-play related to the conflict. Children were encouraged to use these communication techniques to describe their direct experience of trauma, losses suffered during the conflict, and the impact of trauma on their family, peers and their community. Children could, thus, talk about events that led to trauma, their perceived impact (feelings), and resulting symptoms (such as anxiety and nightmares). There was guidance and facilitation by the group moderators, as well as some trauma-specific exercises, but there was no specific structure or order of group themes. Facilitators also referred patients who had more serious symptoms (prolonged bereavement reaction or suicidal ideation)


INTERVENTION 2:

Name: Teacher education

Delivered by:

  • Title/name of NSHW/OPHR and number: Teachers (number not specified)
  • Selection: Not specified
  • Educational background: Not specified
  • Training (contents, duration and by whom): 4 training sessions by main author (consultant child psychiatrist). Contents: meaning of trauma, consequences, and how to deal with such problems
  • Supervision: Not specified
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: Over 4 sessions
  • Content of intervention: Teachers provided information to children on the impact of trauma on different areas of the child's life, and aimed, through education, to normalise the child's response. They also referred patients who had more serious symptoms (prolonged bereavement reaction or suicidal ideation)


CONTROL: Usual care (no intervention), but were on wait-list for crisis intervention after the follow-up

CO-INTERVENTIONS: None


OutcomesPatient: Assessment of PTSD reactions - CPTSD-RI; depression symptomatology - CDI

Carer: None

Process/health worker outcomes: None

Economic outcomes: None

Time points: baseline and 3 months (post intervention)


NotesSource of funding: Not mentioned

Notes on validation of instruments: Both tools validated in settings

Additional information (e.g. provide by authors, existence of a published study protocol): None

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: None


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskComment: This was a non-random method

Allocation concealment (selection bias)High riskComment: This was a CBA study so is labelled as high risk

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: No blinding which would not be possible, but unlikely to have an effect on outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Unclear riskComment: It is not clear if the team measuring outcomes are the same or not as those moderating the intervention

Baseline outcome measurements similarHigh riskComment: In education group, there are lower rates of 'likely depression' and higher rates of 'likely PTSD' even though the means are roughly similar. They are not adjusted for

Baseline characteristics similar?Low riskQuote: "The large family size and low socioeconomic status were striking across the sample. The three groups did not differ significantly on parental employment status, family size, or family income. As stated earlier, there were only female pupils in the education group. The mean age significantly differed between the three group but it does not have the impact on the outcome"

Comment: These were adjusted for

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: There seems to be 100% follow-up and all outcomes seem to have been reported

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: Not mentioned

Protection against contaminationLow riskComment: The groups are in different geographical locations so low risk of contamination

Reliable primary outcome measuresLow riskComment: Validated scores used though no inter-rater reliability reported

Selective reporting (reporting bias)Low riskComment: Not able to find protocol, but compared with methods section, all outcomes reported

Other biasLow riskComment: None detected

Tiwari 2010 RCT China

MethodsStudy design: RCT

Duration of study: February 2007 to June 2009


ParticipantsCountry: Hong Kong, China

Income classification: Middle income

Geographical scope: Urban and rural parts covers 3 districts of Hong Kong

Healthcare setting: Community setting

Mental health condition: Depression

Population

  • Age: ≥ 18 years
  • Gender: Female
  • Socioeconomic background: 72% of women had financial hardship, more women in intervention group received comprehensive social security assistance (33% vs. 9%) and said they were in need of financial support (65%). Most had a minimum of 13 years' education, over half born in mainland China but most 70% resident in Hong Kong for < 7 years, majority were married, 50% had ≤ 1 child, 15% had chronic illness, 30% employed (80% of partners employed)
  • Inclusion criteria: Women aged ≥ 18 years who resided or worked in 1 of the districts covered by the community centre, screened positive for IPV (using the Chinese Abuse Assessment Screen)
  • Exclusion criteria: Women were excluded from the study if they could not communicate in Cantonese or Putonghua, the 2 main Hong Kong dialects used in this study for administering the intervention and collecting data


InterventionsStated purpose: To determine whether an advocacy intervention would improve the depressive symptoms of Chinese women survivors of IPV.

INTERVENTION:

Name: Less intensive advocacy intervention

Delivered by:

  • Title/name of NSHW/OPHR and number: Research assistants (social workers) the number of research assistants not specified
  • Selection: Not mentioned
  • Educational background: Masters in social work
  • Training (contents, duration and by whom): 5 days' training: how to institute the intervention in culturally appropriate, empathetic manner base on empowerment and social support protocols. 2 investigators (PhDs from school of nursing) trained, materials used were protocols, etc. as per under training for intervention
  • Supervision: Checking by 2 investigators on telephone logs
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: First component: delivered for 30 minutes as 1-to-1 interview by a research assistant  at beginning of 12-week intervention. Second component: telephone social support: 12 weekly telephone calls (by research assistant) and 24-hour access to hotline for additional social support
  • Content of intervention: 2 components: 1. empowerment protection, enhance choice making and problem solving - Dutton's empowerment model (modified from Parker model of Abuse Prevention Protocol) - given an empowerment pamphlet (reinforce info provided). 2. telephone social support: (based on Cohen's social support theory); and 24-hour access to hotline for additional social support. In addition, free to choose other care/services


CONTROL: Enhanced usual care, i.e. usual community services provided by community centre or its outreach sites - supportive services but not designed for abused women

CO-INTERVENTIONS: None


OutcomesPatient: Change in depressive symptoms* (Chinese version of the BDI II)* between baseline and 9 months. Changes in IPV § (Chinese Revised Conflict Tactics Scales), health-related QoL (12-Item Short Form Health Survey), and perceived social support § (Interpersonal Support Evaluation List) between baseline and 9 months

Carer: Not applicable

Process/health worker outcomes: None

Economic outcomes: None

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: baseline, 3 months and 9 months


NotesSource of funding: This study was supported by the Health and Health Services Research Fund awarded by the Food and Health Bureau of the Hong Kong SAR Government (project 04060741)

Notes on validation of instruments (screening and outcomes): Validated tools

Additional information: Study protocol

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: NCT01054898


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Participants were randomised (1:1) to the intervention or control group according to a list of random permutations prepared by computer-generated blocked randomisation performed by a research staff member who had not been involved in participant recruitment"

Allocation concealment (selection bias)Low riskQuote: "The block size was kept secure by the randomiser, and the order of allocation was centrally controlled to avoid any bias in selection."

"The allocation sequence was concealed in opaque envelopes. At the time of randomisation, the research assistant who had successfully recruited a participant called the site investigator, who then opened the envelope containing the group assignment. To ensure random assignment, no detail was provided to the site investigator about the identity of the participant"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Not blinded but unlikely to affect outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote: "Blinding appeared to be sustained, because none of the assessors knew the group assignment of the participants until they came to the last question, which solicited the participants’ evaluation of the intervention or usual community services"

Comment: All instruments involve scales/judgements of assessor. But assessors were not involved in the design of the study, did not know the study hypotheses, and were blinded to group assignment

Baseline outcome measurements similarLow riskComment: All similar

Baseline characteristics similar?Low riskComment: All parameters similar except intervention group had significantly more access to social security insurance than did control group. This was unlikely to make a big difference to the outcome of the intervention, however, particularly as the outcome was that there was not much difference between intervention and control groups

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: No dropouts after randomisation. 2 eligible refused to participate before randomisation. Low dropout because of intensive tracking system they had in place. 88% of women received all 12 weeks of telephone support. No participant received < 10 weeks

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No adverse outcomes reported

Protection against contaminationLow riskComment: 1-to-1 interview done so intervention unlikely to have contaminated control. IPV women often isolated and did not discuss their situation (as also discussed by authors in discussion)

Reliable primary outcome measuresLow riskQuote: "In addition, across the length of the study, 15% of the telephone logs including the needs expressed and the responses provided were randomly checked for adherence to the protocol. If adherence dropped below 90%, retraining and observation were conducted until a return to 90% or greater adherence was achieved. The random checks revealed that adherence did not drop below 90%. But also many scales with self-reported outcomes which are less reliable"

Selective reporting (reporting bias)Low riskComment: No selective reporting

Other biasLow riskComment: None detected

Tol 2008 C-RCT Indonesia

MethodsStudy design: Cluster RCT, schools as unit of allocation, individuals as unit of analysis

Duration of study: March to December 2006


ParticipantsCountry: Indonesia

Income classification: Lower-middle 

Geographical scope: Rural, in Poso district of Central Sulawesi

Healthcare setting: School

Mental health condition: PTSDsymptoms

Population: Patient

  • Age: 8-13 years (80% between 9 and 11 years)
  • Gender: Both (50/50 boys and girls in sample)
  • Socioeconomic background: 25% of population in province below poverty line and living off agriculture, 20% intervention group and 30% control group displaced, most houses had 4.5 household members, most suffered about 4 violent event types on average. 31% Muslim; 47% Protestant
  • Inclusion criteria: Children screened for exposure to traumatic events, PTSD symptoms or depressive anxiety symptoms, with the use of symptom checklists
  • Exclusion criteria: Serious psychopathology and psychiatric disorders (mutism, retardation, psychotic symptoms) or incapability to function in a group (conduct disorders, harming others), as judged by local psychosocial counsellors


InterventionsStated purpose: To assess the efficacy of a school-based intervention designed for conflict-exposed children, implemented in a low-income setting

INTERVENTION:

Name: CBI

Delivered by:

  • Title/name of NSHW/OPHR and number: Paraprofessional interventionists (number not specified)
  • Selection: Selected from local target communities, based on selection procedure assessing social skills through role-plays
  • Educational background: At least a high school education, without former mental health background but some experience as volunteers in humanitarian programmes
  • Training: 2-week training programme, trained by national staff working for partnering humanitarian organisation Church World Services, based on a manual developed by the Centre for Trauma Psychology in Boston which conforms to current expert-based consensus and similar school-based interventions
  • Supervision: Unspecified
  • Incentives/remuneration: Unspecified


Intervention details:

  • Duration/frequency: 15 sessions with groups of 15 children over 5 weeks manualised CBI
  • Content of intervention: manualised CBI, CBT and creative-expressive techniques in a structured format: week 1: psychoeducation; week 2: stabilisation awareness self esteem; weeks 3 and 4 trauma narrative; week 5: reconnecting child and group to social context/ resiliency, etc. and sharing trauma stories


CONTROL: Usual care (wait-list control)

CO-INTERVENTIONS: None


OutcomesPatient: PTSD (CPSS) and depressive symptoms (DSRS)*

Secondary outcomes:

1. Anxiety (SCARED)

2. Aggression (Children's Aggression Scale for Parents) §

3. Daily functioning (Children's Function Impairment) 

4. Social support (Social Support Inventory Scheme; SSIS) §

5. Coping (Kidcope) §

6. Functioning (Impairment in functioning) 

7. Hope (Children's Hope Scale) §

Carer: n/a

Process/health worker outcomes: None reported

Economic outcomes: Treatment outcome, treatment satisfaction, therapist burden, level of selection to care, care package cost (see: Jordans 2011)

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: Baseline, 1 week, 6 months


NotesSource of funding: PLAN Netherlands

Notes on validation of instruments: Validated in local context, "to measure internal reliability, we used a Cronbach Alpha and for 2-week test-re-test reliability, the Spearman-Brown coefficient"; screening measure was a self developed symptom checklist which was not validated against clinical interview.

Additional information: www.controlled-trials.com/ISRCTN25172408

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: ISRCTN25172408


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComment: Randomisation using government-provided list of schools, excluded single religious and private schools, random selection using SPSS function

Allocation concealment (selection bias)Low riskComment: SPSS allocation function

Quote: "Select exact amount of cases randomisation"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Not possible to blind participants or personnel, but unlikely to affect outcome

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
High riskQuote: "Assessors were not blinded to treatment status, and this could have biased results"

Comment: Child self ratings with help of assessors who were not blinded to treatment condition

Baseline outcome measurements similarLow riskComment: No differences except for parent-rated aggression was higher in wait-list control group (P value = 0.03)

Baseline characteristics similar?Low riskComment: Differences in gender, age and % displaced, controlled for in analyses

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: Good follow-up data (more than 90%) for 1 week and 6 months for both intervention and control

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No adverse outcomes reported

Protection against contaminationLow riskComment: Randomisation done by school. In addition, there is a wait-list control so unlikely for groups to share information

Reliable primary outcome measuresLow riskComment: Inter-rater reliability high (k = 0.901) for dichotomous items and continuous items (k = 0.988)

Selective reporting (reporting bias)Low riskComment: Outcomes reported in methods and in online trial protocol are reported in results

Other biasLow riskComment: ICC done and adjustment for clustering; intervention fidelity assessed (89.76% adherence)

Tol 2012 C-RCT SriLanka

MethodsStudy design: Cluster RCT, unit of allocation by schools, unit of analysis: individuals

Duration of study: September 2007 to March 2008


ParticipantsCountry: Sri Lanka

Income classification: Lower-middle

Geographical scope: Urban and rural, Tellippallai and Uduvil divisions of the Jaffna district of northern Sri Lanka 

Healthcare setting: School-based group intervention

Mental health condition: PTSD

Population: children/adolescents

  • Age: 9-12 years
  • Gender: Both
  • Socioeconomic background: War-traumatised area with rationed food, and other essential supplies, curfews, road blocks, disappearances, extra judicial killings; "In August 2006, a peace agreement that had been observed since 2002 was abandoned, followed by closure of the only land road into the Jaffna peninsula. The subsequent period was characterized by rationed food and other essential supplies, curfews, road blocks, disappearances, extra judicial killings, and skirmishes between the army and Liberation Tigers"
  • Inclusion criteria: Those who scored positive using the Child Psychosocial Distress Screener (CPDS); aged 9-12 years; also included children reporting severe mental problems and the latter were provided individual supportive counselling in addition to being enrolled in the study (19 children, 4.8%)
  • Exclusion criteria: Not specified


InterventionsStated purpose: To examine outcomes, moderators and mediators of a preventive school-based mental health intervention implemented by paraprofessionals in a war-affected setting in northern Sri Lanka

INTERVENTION:

Name: School-based group intervention

Delivered by:

  • Title/name of NSHW/OPHR and number: Non-specialised personnel, number not specified
  • Selection: Locally identified
  • Educational background: At least a high-school diploma and were selected for their affinity and capacity to work with children as demonstrated in role plays and interview
  • Training (contents, duration and by whom): trained 1 year before intervention, manualised intervention, not specified by who
  • Supervision: There is some supervision but no details mentioned
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: 5-weeks, 15 sessions (about 60-minute sessions). The intervention followed a specific structure within and between sessions, with the following foci: information, safety and control in week 1 (sessions 1-3); stabilisation, awareness and self esteem in week 2 (sessions 4-6); the trauma narrative in week 3 (sessions 7-9); resource identification and coping skills in week 4 (sessions 10-12); and reconnection with the social context and future planning in week 5 (sessions 13-15). Each session is divided into 4 parts, starting and ending with structured movement, songs and dance with the use of a 'parachute' (i.e. large circular coloured fabric). The second part is based on a 'central activity' focused on the main theme of that week (e.g. a drama exercise to identify social supports in the environment, or drawing of traumatic events), and the third part was a co-operative game (i.e. a game in which all children had to participate in order to promote group cohesion


  • Content of intervention: The manualised intervention consisted of cognitive behavioural techniques (psychoeducation, strengthening coping and guided exposure to past traumatic events through drawing) and creative expressive elements (co-operative games, structured movement, music, drama and dance) with groups of around 15 children, aimed at decreasing symptoms of common mental disorders and strengthening protective factors


CONTROL: Wait list control

CO-INTERVENTIONS: The intervention was part of a larger public mental health programme for children affected by war, including primary and tertiary prevention approaches


OutcomesPatient: CPSS*, DSRS (depression scale)*, SCARED-5 (anxiety)*, SDQ §, psychological complaints, functional impairment scale, exposure to violence and daily stressors local scale §, KIDCOPE (daily stressors) §

Carer: n/a

Process/health worker outcomes: None

Economic outcomes: Treatment outcome, treatment satisfaction, therapist burden, level of selection to care, care package cost; see: Jordans 2011

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: Baseline, 1 week, 3 months


NotesSource of funding: PLAN Netherlands 

Notes on validation of instruments (screening and outcomes):

Primary outcome measures: primary outcome measures for PTSD, depression and anxiety have unknown local criterion validity

Secondary outcome measures:

SDQ: validation in tamil (Lukumar 2008)

Psychological complaints: Not validated

Functional impairment scale: Validated in Tol 2011a

Exposure to violence and daily stressors local scale: not mentioned if validated

KIDCOPE (daily stressors): validated in Spirito 1988

Additional information: none

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: None given


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "We used a two-step randomisation procedure. First, within district divisions, we randomly allocated each division to either the intervention or waitlist control condition (see Figure 1). Second, we randomly selected schools for inclusion in the study. All schools on the government-provided list were eligible"

Comment: The random sequence generation is not specified

Allocation concealment (selection bias)Unclear riskComment: Not specified

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: Not blinded but unlikely to affect outcomes

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Unclear riskQuote 1: "Group of assessors not involved in service delivery"

Quote 2: "Assessors were not informed about which schools received intervention."

Quote 3: "Although we did not disclose study condition to assessors and we selected research assessors external to intervention activities, we were not able to control possible disclosure of study condition by children participating in the study"

Comment: May have impacted on outcome assessment

Baseline outcome measurements similarLow riskComment: Similar

Baseline characteristics similar?Low riskQuote: "We compared demographic characteristics (gender, religion, type of house, occupation caregiver, household size), exposure to violence, ongoing war-related stressors, and scores on outcome measures, and found no statistically significant differences between study conditions. The sample consisted of more boys (61.4%) than girls, was dominantly of Hindu religion (81.0%), and children were between 9 and 12 years old (mean 11.03±1.05)"

Comment: Similar baseline characteristics from what text says (though socio-demographics not present in a table)

Incomplete outcome data (attrition bias)
Efficacy data
Low riskComment: Very small dropout rate (only 1/200 in each of control and intervention group)

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskQuote: "For girls, we found an unintended harmful effect, such that girls in the waitlist condition showed larger improvements in PTSD symptoms than girls in the intervention condition"

Comment: Adverse effects looked for via the intervention

Protection against contaminationLow riskComment: Cluster trial so low risk of contamination

Reliable primary outcome measuresHigh riskQuote: "Our primary outcome measures for PTSD, depression, and anxiety have unknown local criterion validity" "internal reliability of some of the measures was slightly less than acceptable (no table for anxiety symptoms)"

Selective reporting (reporting bias)Unclear riskComment: Do not have protocol to check against prespecified outcomes. However, outcomes are similar to other studies by the same authors

Other biasLow riskComment: None detected

Wolmer 2005 CBA Turkey

MethodsStudy design: CBA study

Duration of study: Some months post 1999 earthquake in Turkey, then 3.5 year follow-up


ParticipantsCountry: Turkey

Income classification: Upper-middle

Geographical scope: Urban, East Marmara region heavily affected by earthquake (18,000 people dead, 150,000 homes destroyed, thousands homeless), village adjacent to Adapazari (Note: the term 'village' was used to describe established displacement areas rather than a rural setting)

Healthcare setting: 3 schools: 1 in the temporary 'Israeli village' established post earthquake by Israeli humanitarian aid where the original intervention took place, and 2 schools equally affected by the earthquake in Adapazari where several of the children who initially received the intervention in the 'Israeli village' had moved to

Mental health condition: PTSD symptoms due to earthquake

Population: Displaced school-aged children

  • Age: 9-17 years
  • Gender: Both
  • Socioeconomic background: Post earthquake area, families displaced in prefabricated houses in temporary villages
  • Inclusion criteria: Experienced 1999 earthquake, displaced school-aged children, grades 1-5
  • Exclusion criteria: Not specified


InterventionsStated purpose: "Child survivors of a catastrophic earthquake in Turkey were evaluated three and a half years after the event, and three years after a sub-group participated in a teacher-mediated intervention developed by the authors. The goal of this follow-up study was to determine the long-term effectiveness of the original intervention"

INTERVENTION:

Name: School reactivation programme

Delivered by:

  • Title/name of NSHW/OPHR and number: 8 teachers (number provided by author)
  • Selection: The principal and teachers in a school in the prefabricated 'Israeli village'
  • Educational background: Trained as teachers
  • Training: First, 1 group session (modified debriefing protocol), empowerment activity delivered by study authors; second, taught sessions about issues related to children's responses to trauma and how to implement disaster-related school reactivation programme, introductory training provided by study authors, intervention skills trained by local professional team
  • Supervision: Ongoing weekly training, supervision and support from local professional team who conducted intervention training
  • Incentives/remuneration: Not described


Intervention details:

  • Duration/frequency: 1 introductory meeting with parents, then eight 2-hour meetings (over 4 weeks - 2 meetings per week) focused on aspects of recovery process
  • Content of intervention: The teachers took charge of class activation in which all children in the class participated. The eight 2-hour meetings focused on various aspects of the recovery process: "restructuring traumatic experiences, dealing with intrusive thoughts, establishing a safe place, learning about the earthquake and preparing for future earthquakes, mourning the ruined city, controlling body sensations, confronting posttraumatic dreams, understanding reactions in the family, coping with loss, guilt, and death, dealing with anger, extracting life lessons, and planning for the future. The programme combined psychoeducational modules, cognitive-behavioral techniques, play activities, and ongoing documentation in personal diaries"


CONTROL: In Wolmer 2003: the control was a group of 101 displaced children from another area not affected by the earthquake. For 2005: they were from a similar background and exposed to the earthquake (from same schools) but had not received the intervention

CO-INTERVENTIONS: None


OutcomesPatient: Child Report: CPTSD-RI, Traumatic Dissociation and Grief Scale (TDGS), mother report (of child): Traumatic Dissociation and Grief Scale (TDGS). Teacher report (of child): daily functioning assessment (academic, social, general conduct)

Carer: n/a

Process/health worker outcomes: None reported

Economic outcomes: None

Time points: 3.5 years post earthquake


NotesSource of funding: The Association for Children at Risk, Israel; The American Jewish Joint Distribution Committee; and The American Jewish World Service

Notes on validation of instruments: Validation of CPTSD-RI not specified for local context, no validation report for teacher scale, TDGS developed and used in local context by authors (Laor 2002)

Additional information: Protocol not found

Prospective trial registration number: Not given


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskComment: Non-randomised CBA study

Allocation concealment (selection bias)High riskComment: CBA study

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "It is important to emphasize that the teachers were unaware of the children’s participation in the School Reactivation Program"

Comment: Participants could not be blinded but teachers who filled out ratings were blinded

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskComment: Self report of children and parents not blinded to treatment group but teachers were blinded

Baseline outcome measurements similarUnclear riskComment: No outcome measurements for control group so difficult to assess

Baseline characteristics similar?Low riskComment: Yes they are similar

Incomplete outcome data (attrition bias)
Efficacy data
High riskComment: Only proportion of original participants (in 2003) were included for follow-up (33%)

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskInformation from author: "We are not aware of any adverse outcome"

Protection against contaminationLow riskComment: Intervention happened in 1 school only initially, low risk for contamination

Reliable primary outcome measuresHigh riskComment: Only the grief scale was done by both parents and children to correlate. There are, however, within each measure no correlation coefficients or measures of agreement

Selective reporting (reporting bias)Low riskComment: Outcomes reported in methods reported in results

Other biasLow riskComment: None detected

Yeomans 2010 RCT Burundi

MethodsStudy design: RCT (3 armed trial)

Duration of study: Spring 2007 - ?


ParticipantsCountry: Burundi

Income classification: Low-income

Geographical scope: 2 rural communities in north-central Burundi, country that suffered a civil war in which over 300,000 people were killed

Healthcare setting: Community groups

Mental health condition: PTSD

Population: Patient

  • Age: Mean age 38.6 years (SD 12.8)
  • Gender: Both, 44.4% female
  • Socioeconomic background: 48.3% lived in camps, only 5% of sample completed > 6 years of education, ethnic composition was 52% Hutu and 47.6% Tutsi, almost all were directly victimised by violence during or since conflict onset in 1993; most not fully literate
  • Inclusion criteria: Among future participants of 2 trauma workshops offered by internally displaced people camps
  • Exclusion criteria: Not specified


InterventionsStated purpose: The current study aimed to evaluate the effects of PTSD psychoeducation within a larger trauma healing and reconciliation intervention in a rural region of Burundi

INTERVENTION 1:

Name: Workshop with psychoeducation

Delivered by:

  • Title/name of NSHW/OPHR: Burundian facilitators, number not specified
  • Selection: "Chosen by the nonprofit organisation for their extensive experience with trauma workshop facilitation and for having demographics comparable to participants"
  • Educational background: "Rural, poor, many without substantial formal education, and balanced in gender and ethnicity"
  • Training: "All facilitators had a full day of training dedicated to the modification of the standard workshop to accommodate planned differences in condition"; not specified by whom
  • Supervision: Not specified
  • Incentives/remuneration: Not specified


Intervention details:

  • Duration/frequency: The standard intervention included 2 phases. 6 groups of approximately 20 participants gathered for 3 days, and 1 month later each workshop group reconvened for a full-day follow-up session during which major workshop components were reinforced
  • Content of intervention: The 3-day workshop used discussion, experiential exercises aimed at fostering interpersonal exchange, and games to explore themes of trauma, loss, anger, trust and the roots of violence; The Healing and Reconciling Our Communities workshop manual (African Great Lakes Initiative of the Friends Peace Teams, 2006) emphasised that recovery from trauma lies in the restoration of the relations between community members, and in understanding how trauma can affect these relationships and individuals. The Healing and Reconciling Our Communities program integrates theoretical frames as described by Herman 1997 and Staub 2005. Each of Herman's 3 stages of recovery from trauma were incorporated within the Healing and Reconciling Our Communities workshop design. There was emphasis on the need for personal recovery and interpersonal reconciliation by means of "a neighbour-to-neighbour healing process, which must include cognitive and affective engagement with experience in the context of interpersonal support". Psychoeducational content on the first day of the workshop included a 90-minute presentation and discussion of the 17 specific symptoms of PTSD. An orientation to and solicitation of potential Criterion A (according to the DSM) events was also included. These ideas were reviewed again in the afternoon, and participants shared how they had been affected by the traumatic events they had experienced (1 hour additional). Coping with trauma was addressed in terms of teaching relaxation skills with a substantial emphasis on repairing relationships with community members


INTERVENTION 2:

Name: Workshop without psychoeducation

Delivered by:

  • Title/name of NSHW/OPHR: Burundian facilitators, number not specified
  • Selection: "Chosen by the nonprofit organisation for their extensive experience with trauma workshop facilitation and for having demographics comparable to participants"
  • Educational background: "Rural, poor, many without substantial formal education, and balanced in gender and ethnicity"
  • Training (contents, duration and by whom): "All facilitators had a full day of training dedicated to the modification of the standard workshop to accommodate planned differences in condition"; not specified by whom
  • Supervision: Not specified
  • Incentives/remuneration: Not specified


Intervention details: (according to NSHWs/OPHRs and whether aimed at carers or patients, or both)

  • Duration/frequency: The standard intervention included 2 phases. 6 groups of approximately 20 participants gathered for 3 days, and 1 month later each workshop group reconvened for a full-day follow-up session during which major workshop components were reinforced
  • Content of intervention: The active workshop condition with no psychoeducation was identical to that described in intervention 1, with 2 exceptions. First, this condition did not include the introduction of PTSD psychoeducational content. Second, to ensure that both workshop conditions were of equal length, additional time was devoted to an exercise in which participants formed pairs and answered questions provided to them. The assigned topics facilitated communication around perspectives on trust, safety, sense of security, and interethnic relations in the community (e.g. "someone I trust and why", "a time I overcame fear"). Importantly, participants were encouraged to discuss how they have been affected by events during the war, but unlike in the workshop with the psychoeducation condition, facilitators did not augment this discussion with any PTSD psychoeducational content


CONTROL: Wait-list control; received workshops after the second assessment period

CO-INTERVENTIONS: None


OutcomesPatient: HSCL-25 plus 10 somatic symptoms from HSCL-58 comprised a hybrid HSCL instrument (anxiety and depression and global measure of emotional distress); HTQ Part IV (Trauma); HTQ-b (guilt, loneliness, shame, betrayal and rumination) §

Carer: n/a

Process/health worker outcomes: Facilitators completed a report after each workshop in reference to the integrity of the condition. Reports indicated that workshop components were consistent as planned and true to treatment condition. Facilitators did report 3 instances (in the course of over 2500 participant-hours) in which a participant proposed the concept of 'trauma' during a brainstorm about the consequences of the war. As previously instructed, the facilitators acknowledged the statement, but did not foster discussion on it §

Economic outcomes: None

(*: primary outcomes of the study; §: outcomes that we have not reported in this review)

Time points: 6 weeks pre intervention and 2 weeks post intervention


NotesSource of funding: Not specified

Notes on validation of instruments (screening and outcomes): HSCL: for depression scale a sensitivity of 0.88 and specificity of 0.73; proven to be culturally sensitive with samples around the world and has demonstrated sufficient validity and reliability (Fox 2002); HTQ Part IV and HTQ-b : Not validated in local setting; Trauma Discourse exposure interview : Not validated in local setting

Handling the data: As per footnotes in data and analysis

Prospective trial registration number: None


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Participants were blocked according to ethnicity and gender and randomly assigned to condition"

Allocation concealment (selection bias)Low riskQuote: "In each community, using a computerized random-number generator, participants were assigned to condition according to stratified randomisation (by gender and ethnicity) to either workshop with psychoeducation, workshop without psychoeducation, or waitlist control"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Participants and interviewers (at pre and posttest) were blind to condition assignment"

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskComment: No objective outcomes

Blinding of outcome assessment (detection bias)
subjective outcomes
Low riskQuote: "Facilitators were not blind to condition as they required awareness of differences in content between conditions"

Comment: Participants were blinded to treatment condition (with psychoeducation or not)

Baseline outcome measurements similarLow riskQuote: "There were no significant baseline differences between the three treatment groups across age, gender, ethnicity, symptoms, education level, traumatic events experienced, or on prior exposure to trauma discourse"

Baseline characteristics similar?Low riskQuote: "There were no significant baseline differences between the three treatment groups across age, gender, ethnicity, symptoms, education level, traumatic events experienced, or on prior exposure to trauma discourse"

Incomplete outcome data (attrition bias)
Efficacy data
Low riskQuote: "Participants received a small reimbursement for transportation expense only"

Comment: Only a few participants not available at follow-up points

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Unclear riskComment: No adverse outcomes reported

Protection against contaminationLow riskComment: Study done before workshops were delivered later in communities, assessed for prior discourse on trauma

Reliable primary outcome measuresUnclear riskComment: No kappa values given; also not all tools are validated in local context

Selective reporting (reporting bias)Unclear riskComment: No protocol

Other biasLow riskQuote: "Participants received a small reimbursement for transportation expenses only"

Comment: Unlikely to affect outcomes

Zambori 2002 CBA Hungary

MethodsStudy design: CBA study

Duration of study: Enrollment of GP practices: 1 September 1998 to 1 March 1999. 12 months retrospective and 12 months prospective to the intervention. Finished March 2000


ParticipantsCountry: Hungary

Income classification: Upper-middle income

Geographical scope: Urban (Budapest)

Healthcare setting: PC setting

Mental health condition: Common mental disorders (include anxiety and depression)

Population: Adults attending general practices (intervention) or psychiatrist (control)

  • Age: 18-64 years
  • Gender: Both
  • Socioeconomic background: No break up
  • Inclusion criteria: Anxiety, mood disorders or uncomplicated bereavement
  • Exclusion criteria: Mild agoraphobia excluded


InterventionsStated purpose: To estimate the changes in health utilisation and indirect costs of anxiety and affective disorders (mainly depression) in PC patients after initiation of mental health treatment

INTERVENTION:

Name: PC vs. psychiatric care for common mental disorders

Delivered by (NSHW or OPHR and title)

  • Title/name of NSHW/OPHR and number: GP


  • Selection: 12 accepted to participate out of 25 GPs in the 12 practices
  • Educational background: Highly qualified
  • Training: Already qualified doctors no further training given, interviewers for screening were given 1 week' training
  • Supervision: No supervision. GPs in Hungary are able to refer patients to the psychiatrists (information from author)
  • Incentives/remuneration: Information from author: no specific incentives/remuneration


Intervention details:

  • Duration/frequency: As per usual consultation
  • Content of intervention: Information from author: In Hungary, usual GP care consists of prescribing medications and referring patients to specialist or hospital care if needed. They also provide non-specific psychotherapy in some cases (mostly supportive therapy), but this is not very frequent. Therapy is most often limited to pharmacotherapy


CONTROL: Psychiatric care. Psychiatric diagnosis, care and follow-up

CO-INTERVENTIONS: None


OutcomesPatient: BDI (diagnosis of depression); QLDS; DIS (Diagnostic Interview Schedule - Hungarian version)

Carer: Not applicable

Process/health worker outcomes: Number of healthcare visits excluding psychiatric care; number of psychiatric visits, number of days spent in hospital, number of days spent on sick leave

Economic outcomes*: Table 5 and 6: consultation cost; psychiatric drug costs; general prescription drugs cost; laboratory and diagnostic costs; hospitalisation cost

(* = primary outcomes of the study)

Time points: Baseline and 1 year


NotesSource of funding: Servier Educational Fund

Notes on validation of instruments (screening and outcomes): BDI and QLDS and DIS have all been validated in the Hungarian version

Additional information: Information from authors acquired to complete above information

Handling the data: As per footnotes in data and analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskComment: No random sequence generation done

Allocation concealment (selection bias)High riskComment: No allocation concealment done

Blinding of participants and personnel (performance bias)
All outcomes
Low riskComment: No but unlikely to affect

Blinding of outcome assessment (detection bias)
objective outcomes
Low riskInformation from author: "The sick leave/hospitalisation data was collected from patient’s charts at the GP office. As per Hungarian regulations GP’s are responsible for documenting sick-leave for outpatients and also obliged to collect this data on hospital stays"

Comment: Number of visits and days spent in hospital/sick at home from records so objective

Blinding of outcome assessment (detection bias)
subjective outcomes
High riskComment: All are from self administered instruments. Therefore, likely to be some detection bias

Baseline outcome measurements similarHigh riskQuote: "Potential group differences in severity of psychiatric illness might have resulted from the fact that the treatment group was recruited from the first 1,000 attenders, with an over sampling of patients with greater disease burden and health service utilization. Thus, differences in the severity of illness and reasons not attributable to treatment effects may play a role in the change in the rate of service use"

Baseline characteristics similar?High riskQuote 1: "The groups differed in terms of mean age and sex ratios. The mean ages for the treatment group, control group, and treatment-refusal group were 46.3 years, 36.1 years, and 39.5 years respectively. The respective sex ratios (female:male) were 1:0.7, 1:0.78 and 1:0.67. These differences were corrected in the statistical analysis"

Quote 2: "Due to the assignment process, there were significant differences in the baseline characteristics of the groups"

Incomplete outcome data (attrition bias)
Efficacy data
Unclear riskComment: We have incomplete information on dropouts between year 1 and 2 and authors said that there was not reliable data for this

Incomplete outcome data (attrition bias)
Safety data (e.g. adverse events)
Low riskInformation from author: They did not measure adverse outcomes apart from hospitalisation rates

Protection against contaminationLow riskComment: The GP group was unlikely to have access to the same psychiatrists, though they could go and see other psychiatrists. The psychiatrist group (intervention group) would have access to visiting their GP too. However, low risk of contamination

Reliable primary outcome measuresLow riskComment: Validated tools or objective outcomes used. No information on inter-rater reliability for DIS scores. BDI and QLDS were self administered and there was no other checking of these facts with other measures which would increase the risk of bias

Selective reporting (reporting bias)Low riskInformation from author: "We had an accepted protocol/research plan that was approved by local ethics committee in place prior to starting the study. We were planning to assess the effect of different intervention on quality of life, but the QoL data obtained from the study was not sufficient for statistical analysis"

In addition, regarding our request for BDI scores at baseline and follow-up and follow-up numbers for psychiatric visits, the author responded: "We did not publish these data because it was unreliable and methodologically biased"

Comment: No selective reporting, though some reporting of things that would be useful not done like costs of psychiatric drugs

Other biasLow riskComment: No other sources of bias detected

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Abiodun 1991Study trial had no control

Acha 2007No control. Related to treatment adherence

Acuda 1992Intervention included both specialists and non-specialists but not able to separate out the two. Also participants did not have a definite diagnosis of alcohol problem. Intervention classifies as secondary prevention

Adamolekun 2000The study trial had no control. It was an evaluation

Adams 2012No control and did not meet ITS criteria

Ahn 2004The trial intervention and control was mainly led by the non-specialists

Ali 2010Uncontrolled study (2 groups both given counselling by NSHWs)

Alvarado 2011No control and did not meet ITS criteria

Anand 2005It was related to diagnostic accuracy but not an intervention where the health workers were involved

Apil 2011High income country (Netherlands)

Aravena 2011An evaluation of the clinic after PHC doctors received some specialist training in mental health. There was no control group in the intervention

Arcel 1995Not a trial

Armstrong 2011The EPOC study design criteria not met

Babor 1992A compilation of RCTs. Though NSHWs were involved, it was not possible to separate out specialist from non-specialist in the study. Also patients were not defined yet as a having an alcohol problem, they were heavy drinkers. Classifies as secondary prevention intervention

Babor 1994As for Babor 1992

Bae 2009There was no control group in the intervention

Baker-Henningham 2009The participants targeted were normal children

Bakran 2001Intervention was general medical rehabilitation and not mental health rehabilitation

Balaji 2011The participants targeted for the intervention were only 23% of youths had probable baseline depression and we have decided that over 80% of patients at baseline should have a mental illness

Ball 2000There was no control group

Bangirana 2006Not a trial

Barcala 2009Not a trial. It was permanent training of human resources and the setup of intra- and intersectional networks

Becker 2006No control group

Becker 2007No control group and baseline data

Becker 2009Not all CBA EPOC criteria met

Beckerleg 1996No control group and three is no baseline data

Bedregal 2010A pilot study to investigate the level of children's developments in areas where the Chile government programme is not taking effect. There is no control to this

Bellali 2006A programme description

Berman 1993No control group and also ITS criteria not met

Bichescu 2007A specialist-led intervention (psychology student)

Blair 2006Does not meet EPOC ITS study

Boavida 2000No control group and was not an ITS

Bochen 2006A case study. No control group

Bondy 1993No control group and was not an ITS

Booth 2011Peer educator and network groups could not be considered separately, since the former were trained to recruit and influence the latter. No NSHWs in comparator. No actual mental health outcomes

Boothby 2011Not appropriate study design

Borucka 2003No control group

Bower 2001Not a trial

Boyadjieva 1992Mixed group of specialists and non-specialists intervention and no subgroup differences data provided

Bragin 2007No control group

Brown 2005A high-income country

Cabildo 1973It is the description of mental health service in Mexico and is not an intervention

Caciula 2010No control group

Caciula 2010aNo control and did not meet ITS criteria

Calderon 2008No control group and specialist-led intervention

Campillo 1992As for all Babor-related studies, secondary prevention and not able to separate out NSHW from specialist intervention

Carli 2010Secondary prevention initiative.

Castellarin 1985An evaluation of a longitudinal study. Not got 3 points before or after intervention of study so cannot meet the criteria of ITS design as per the EPOC criteria

Catani 2009This trial compares 1 NSHW intervention vs. another NSHW intervention, and no control

Cavlek 2006No control. No baseline data

Cereceda 2011Not correct study design

Cerny 1975A programme description

Chang 2000CBA but did not meet EPOC criteria. Also researcher-led intervention

Chankrachang 2009Specialist intervention

Chapman 1988High-income country

Chatterjee 2003A CBA study but with only 1 control 'site' (because 1 geographic area and 1 outpatient department clinic). Did not meet EPOC inclusion criteria for CBAs

Chatterjee 2005A carrative account not a trial

Chatterjee 2009A cohort study. It had only baseline and endpoint measures so cannot classify as ITS

Chen 2000aNo role of the non-specialist but was a community support group intervention

Chhabra 2010A prevention programme

Chibanda 2011No control and did not meet ITS criteria

Chien 2008An intervention by non-specialist health workers but in secondary care unit (hospital setting)

Chisholm 2000The study was about economic costs described. It was not linked to an RCT

Cho 2011The study design was not appropriate with EPOC criteria

Chou 2002The intervention was based on family member carer

Chow 2010The study was performed in a high-income country

Chowdhury 2004There was only 1 PHC in 1 district so, despite being a CBA, did not meet EPOC criteria. No control group

Chowdhury 2005There was only 1 PHC in 1 district so, despite being a CBA, did not meet EPOC criteria. No control group

Climent 1981There was only 1 intervention site and 1 control site so, despite being a CBA, did not meet EPOC criteria

Climent 1983Patients were not randomized. There was only 1 intervention site and 1 control site so, despite being a CBA, did not meet EPOC criteria

Colon de Marti 1993A programme description and not a trial

Cooper 2002A prevention programme and CBA trial without multiple sites

Cooper 2009Based on depression as secondary outcome - focus is on attachment style between mother and infant

Coyle 1998Paper described a trial but did not actually present data. No subsequent results paper found.

Crawford 2004The setting was a high-income country

Cummings 2008A high-income country

Dabrowski 1998A programme description and not a trial

Das 2006A programme description

Davis 1988A programme description and not a trial

De Arellano 2005Study performed in a high-income country

De Clercq 2001Study design was not appropriate with EPOC criteria

De Jong 1996Did not have multiple before and after points and no control group in the intervention so could not be classified as ITS

Dernovsek 2010A prevention study

Devaramane 2011No control group in the intervention

Devine 2007No control group in the intervention

Dias 2004Intervention design was not linked to an RCT. This was descriptive

Diken 2010A specialist-led intervention where the school counsellors were the specialist in this intervention

Dorji 2006No control group in the intervention

Dvorin 1989Study design did not fulfil EPOC criteria

Eaton 2008No control group in the intervention

Ehntholt 2005Study performed in a high-income country.

Eickmann 2003A prevention study. A CBA study with only 1 intervention site and so was not appropriate

El Gaili 2002An evaluation

El Sayed 2002ITS but only 1 baseline time point (3 follow-up time points) and no control. Did not meet EPOC study design criteria

Ensink 2007The intervention providers were the specialist such as occupational therapists. The study design was not appropriate with EPOC criteria

Erbas 2004No control group in the intervention

Ezard 2010A pilot study and no control group

Farooq 2011Intervention was based on family member carer

Fawzy 2012The participants for the trial were recruited in a high-income country (USA)

Fayyad 2010CBA study but only 1 intervention group and no control group in the trial. So not meeting the EPOC criteria of study design

Feksi 1991No control group

Feksi 1991aThe comparison group had the same NSHW intervention. The point of comparison in the trial was not the NSHW

Fernandes 2007Not a trial with patients. An evaluation of a training course

Fernandes 2011An evaluation of a training programme for primary care workers (no patient outcomes or implementation in practice)

Ferrinho 1993A narrative description of an experience in South Africa

Fischman 1990A case study

Fleischmann 2008There was a mix group of specialists (psychologists) with non-specialists (general doctors, nurses) who were delivering the care at primary level in this trial

Fleming 1999Study was in a high-income country

Friedlander 1985This trial did not have a control group

Futterman 2010CBA study but only 1 intervention site and 1 control site in the trial. So not meeting the EPOC criteria of study design

Gardner 2003This is a prevention strategy

Gentilello 1999A high-income country

Ghasseimi 2005The intervention providers were the specialists (psychiatrist and mental health team)

Ghosh 2004Study design did not meet EPOC criteria for any study designs

Giannopoulou 2006The intervention providers were specialists (psychiatrists and psychiatric nurses)

Goenjian 1997A pre post intervention and trial had no control group

Goldin 2008The intervention appears to compares ratings, no training/intervention to train on 'correct' diagnosis

Gondim 2001No control group in the intervention

Goodfriend 2004No control group in the intervention

Gordon 2004CBA study but 3 intervention groups and no control group in the trial. So did not meet the EPOC criteria of study design

Gruber 2005CBA study but not got several control sites in the trial. So not meeting the EPOC criteria of study design

Guerra 2011A specialist delivered intervention (junior psychologist and social workers)

Guinhouya 2010CBA study but did not have control sites and did not have 3 time points in the trial.So did not meet the EPOC criteria of study design

Guzman 1985A secondary prevention study

Hamadani 2006A prevention study

Han 2010Study design did not meet EPOC criteria and patients not depressed at baseline

Harder 2012A prevention study

Harding 1983ITS trial but less number of before and after follow so cannot be  considered as  ITS as per EPOC criteria

Harris 1985Intervention in high-income country

Hasanovic 2009Cohort study. Did not meet the EPOC criteria of study design

Heather 2006The study design was not correct and appropriate with EPOC criteria

Hegerl 2009CBA study but only 1 site intervention and 1 site control so did not meet the EPOC criteria of study design

Heh 2003CBA study but only one intervention and control group so did not meet the EPOC criteria of study design

Hensel-Dittmann 2011High-income country (Germany)

Hernandez 2003CBA study but only 1 intervention site and 1 control site so did not meet the EPOC criteria of study design

Hu 2006aMixed community and hospital intervention but predominantly hospital based

Idris 2006Participants did not have a mental disorder, they had anxiety relating to mathematics. Not relevant

Igreja 2004CBA study but only 1 site of intervention and control so did not meet the EPOC criteria of study design

Ivanets 1992Mixed group of specialists (psychiatrists, 1 psychologist) and non-specialist (1 health worker)-led intervention, and was secondary prevention

Jacob 2007aThe study design did not meet EPOC criteria

Jacob 2007bThe study design did not meet EPOC criteria

Jain 2010The study discussed role of paraprofessionals but was not a trial

James 2006The participants targeted did not have mental health problems but were HIV positive. So HIV was the outset

Jenkins 2007No control (a pre-post intervention)

Johnson 2011The intervention location was in a high-income country

Jordan 2006A case study and not a trial

Kaaya 1992The intervention location was in a high-income country

Kabura 2005It had no control (a pre-post intervention) and does not meet EPOC CBA criteria

Kaiser 1998Programme description and focus on antiepileptics not health workers

Kalichman 2007The outcomes were for sexual risk behaviour, which included alcohol consumption but it was not measuring a mental disorder as such, just sex behaviour following alcohol. This study classified as prevention related

Kalichman 2008The outcomes were for sexual risk behaviour, which included alcohol consumption but it was not measuring a mental disorder as such, just sex behaviour following alcohol. This study classified as prevention related

Kalichman 2009The outcomes were for sexual risk behaviour, which included alcohol consumption but it was not measuring a mental disorder as such, just sex behaviour following alcohol. This study classified as prevention related

Karnell 2006CBA study but 3 intervention sites; 2 control sites (all schools) so did not meet the EPOC criteria of study design

Kermode 2008No comparators in the trial

Khamis 2004A specialist-delivered intervention (psychology and social work students)

Khan 2009A case study

Kim 2001CBA study but only 1 intervention and 1 control site so did not meet the EPOC criteria of study design

Kitsumban 2009A specialist-delivered intervention. Also mindfulness may count in the same category as yoga, which is not considered as mental health intervention

Klein 2012The study design was appropriate with EPOC criteria

Kozinzky 2012A prevention intervention

Kozulin 2010A specialist-delivered intervention (the mediator and not the health worker)

Kunz 2004High-income country (Miami, USA)

Lafalaise 2003A programme description and not a trial

Lara 2003CBA study but no control group and 2 intervention groups so did not meet the EPOC criteria of study design

Leitch 2009No control group in the intervention

Leteka 2003This was a study to design an intervention but not to evaluate it. No control group

Li 2005CBA study but only 2 points in time measured after intervention. 1 baseline point so did not meet the EPOC criteria of study design. A specialist-delivered intervention. It was secondary care intervention

Li 2009Did not meet EPOC study design criteria

Liu 2010No control group. Did not meet EPOC study design criteria

Luengo-Fernandez 2011Not an RCT

Lund 2009The economic data were not presented within the context of a trial

Machona 1992A secondary prevention programme

Macic 2010A programme description and not a trial

Madianos 1999It had no control  group and was not a trial

Maheswaran 1992Intervention in a high-income country

Mavrommati 2002Did not meet the CBA study EPOC criteria

McAuliffe 1985Did not meet the CBA study EPOC criteria

McCorkle 2000Intervention in a high-income country

Merritt 2007Intervention in a high-income country

Miller 1981Intervention in a high-income country

Mishara 2006A prevention intervention

Mohammad-Alizadeh-Charandabi 2011A prevention intervention

Montazeri 2001The study design was not appropriate with EPOC criteria

Montero 1992The intervention led by mixed group of specialists and non-specialists health workers and is a secondary prevention intervention

Mooren 2003Did not meet the ITS study design EPOC criteria

Moretti-Pires 2011Did not meet the ITS study design EPOC criteria

Morrell 2009High-income country (UK)

Mueller 2011Does not meet the ITS study design EPOC criteria. A cross-sectional post-intervention design

Mufti 1986A narrative summary and not a trial

Murphy 1997A prevention intervention

Murthy 2005An evaluation and no control group

Naeem 2003Did not meet the ITS study design EPOC criteria

Neuner 2004A specialist-led intervention

Ng 2008Specialist social worker-ledintervention. Also no control and only 2 time points measured. Did not meet EPOC ITS criteria

Ng 2009Did not meet ITS study design within EPOC criteria

Nizamie 2009Does not meet ITS study design within EPOC criteria. The intervention is complex with no indication of what role the community health workers have had in improving the outcomes. No control group

Ockene 1999intervention in a high-income country

Okuyemi 2006Intervention in a high-income country

Omerov 1999Intervention in a high-income country

Onbun-Uea 2008No control group

Ooi 2008A specialist-led intervention (2 therapists who held postgraduate degrees in psychology)

Ould 2009No control group

Paek 2009Specialist intervention and non-CBA study

Pai 1985Did not meet the CBA study design EPOC criteria as it has matched cases and control but not enough sites in the intervention

Pal 2007The intervention and control delivered by only 1 health worker (social service officer)

Palyska 1987Does not meet the ITS study design EPOC criteria

Park 2010The SCL-90-R depression scores could not be interpreted as it was not clear if the patients were depressed

Patel 2003aA specialist-led intervention (therapist was specialist)

Patel 2003bThe intervention was regarding the comparison of psychology vs. fluoxetine treatments, but not comparisons of health workers. A specialist-led intervention (psychological therapies administered by professional therapist. Decision on medication done by research team (specialists))

Peltzer 2006A specialist-led intervention (psychologist trainer)

Perrin 2010Intervention in a high-income country

Perry 1989aDid not meet the CBA study design EPOC criteria, which had 4 countries. A prevention study as it did not start with heavy drinkers

Petersen 2012The study design was not appropriate with EPOC criteria

Placencia 1993The intervention is drug treatment (carbamazepine vs. phenobarbitone) but the comparison was the drugs, not the mode of NSHW delivery. A specialist-led intervention (neurologist makes diagnosis at baseline and initiated treatment. Rural doctor administered, following doses and changes)

Powell 2004A prevention study. Participants targeted undernourished children with no baseline mental health

Prasetiyawan, 2006Not a trial, and it described their work implementing programme

Qi 2007Case study. Wrong study design

Qureshi 2001ITS trial design with no control group for training/intervention of primary care workers and did not have enough before/after time points for ITS so the study design was not appropriate with EPOC criteria

Rahman 1998A prevention study

Ramos-Cerqueira 2005The intervention was about screening training for non-specialist health workers, but looked at comparison with specialist diagnosis (accuracy not outcome). The intervention was the training but there was no control group who did not receive training or pre/post test of diagnosis

Ran 2003A specialist-led intervention (mainly conducted by the trained psychiatrists)

Reay 2012High-income country

Reay 2012aHigh-income country

Rhyne 2002A descriptive paper, and not a trial

Rigotti 2009It had no control: comparison data of training programmes of 5 countries

Rotheram-Borus 2011Prevention study for depression and alcohol (as part of a general pregnancy RCT)

Rowe 2007Intervention in high-income country

Sadik 2011Pre- post-test of a training programme. No control

Saltzman 2001Intervention in high-income country

Schoenmakers 2010A high-income country

Schultz 1995Not a trial

Serrano-Garcia 1991It described interventions but none of them were trials

Skounti 2009Not an intervention and had no control. A diagnostic study

Slupczynska-Kossobudzka 1999It had not met the CBA study design criteria which was pre post design with no control and so the study design was not appropriate with EPOC criteria

Smith 2008A prevention intervention

So 2005Inappropriate study design (CBA but only 1 site each in control and intervention)

Sohlberg 1987Intervention in high-income country

Sokhela 1999Non-controlled ITS but does not have 3 baseline and 3 follow-up time points

Staples 2011No control group and did not meet ITS criteria

Stein 1975Study conducted in high-income countries

Stein 2001Not a trial

Stepakoff 2006A programme description

Strain 2001An evaluation but no control group

Suh 2004Economic study not linked to an included RCT

Suh 2004aEconomic study not linked to an included RCT

Suh 2006Economic study that was part of an RCT, which did not fit our inclusion criteria (drug trial)

Tadaka 2004It was a high-income country

Tang 2010A programme description and not a trial

Tareen 2009No control group

Tezel 2006It was none of these comparators: nurse vs. same nurse in the intervention

Tharyan 2005It was diagnostic accuracy study

Tiwari 2005A specialist-led intervention (midwife with a masters degree in counselling)

Tomasevic 1998Not correct study design as there was no baseline data. An evaluation

Tran 2008No control group

Tripathy 2010No mental health intervention. Having confirmed with author (VP) mental health outcomes were included after the trial had started, as an add-on

Turrisi 2009It was a high-income country

Uma 1989Yoga was the intervention and so do not meet our inclusion criteria

Uys 1996It did not meet the CBA study design criteria, which has only 2 clinics, and patients randomised within each so the study design was not appropriate with EPOC criteria

van Emmerik 2002It was high-income country

van't Hof 2011No control and did not meet ITS criteria

Velleman 2003An evaluation and did not have a control group

Vera 2010A specialist-led intervention (trained counsellors or psychologists and psychiatrists did all the interventions)

Vermetten 2007Not a trial and it had no control group

Vijayakumar 2008Did not meet the EPOC CBA study design criteria

Vijaykumar 2006Not a trial

Waitzkin 2011It was high-income country

Walker 2004A prevention study looking at an intervention on how IQ develops

Wallander 2010The results were not published and author not replied for further enquiry

Wang 2006An ITS trial design with no control, and not enough time points so the study design was not appropriate with EPOC criteria. The intervention was a drug (phenobarbital) not a health worker intervention

Wang 2012A specialist-led intervention (peer support group lead by psychiatric nurse)

Wechsberg 2006The outcomes for substance abuse were not related to whether they are disorder-related. The assessment of substance abuse intake was not done through any validated scales and there was no indication of who had a substance-use disorder or not (just measured whether consumption was daily or not, and what type)

Wechsberg 2008The outcomes for substance abuse were not related to whether they are disorder-related. The assessment of substance abuse intake was not done through any validated scales and there was no indication of who had a substance-use disorder or not (just measured whether consumption was daily or not, and what type). Also not adequate comparator

WHO 1996The intervention was led by the mixed group of specialists and non-specialists from the high- and low-income countries

Wilson 1981A case study and not a trial

Wimo 1997Cost of dementia, not related to an included RCT

Wimo 2003It was high-income country

Wimo 2007Cost of dementia, not related to an included RCT

Wolmer 2011A high-income country

Wong 2002A specialist-led intervention (experienced mental health social workers with bachelor's degrees in social work and post-graduate training in mental health)

Wong 2007Excluded as these were standardised patients (actors), not real setting

Wu 2002Prevention intervention, not treatment

Xiao 2009Drug intervention (methadone and detox drug intervention), and not related to a non-specialist worker

Xu 2003Prevention study

Yildiz 2003Uncontrolled before and after study so did not meet EPOC criteria

Yoo 2006CBA study with only 1 intervention site and 1 control site. Did not meet EPOC criteria

Zakroyeva 2008An ITS with only 1 time point baseline and 1 time point for effect. The study design did not meet EPOC criteria

Zavradashvili 2010Uncontrolled before and after study design. Did not meet EPOC criteria

Zencir 2005This cost study is not related to any RCT or other trial. It had no intervention and was just a descriptive cost study of carers of people with Alzheimer's disease

Zhengyi 1997No control group. Did not meet EPOC study design criteria

 
Characteristics of studies awaiting assessment [ordered by study ID]
Abdul 2002

MethodsUnknown

ParticipantsAlzheimer's disease patients

InterventionsGroup support and community based intervention. ? who are the health workers

OutcomesUnknown

NotesUnable to find anywhere online or in libraries

Aljanati 2010

MethodsUnknown

ParticipantsParkinson's disease patients in Uruguay

InterventionsPatients benefit from knowledge, information of their resources, group activities where they do not feel alone with their chronic disease. Family members, often primary carers, receive adequate support. Not known who delivers the intervention

OutcomesUnknown

NotesAuthor not replied - email returned undelivered

Azizi 2010

MethodsRandom allocation of patients

ParticipantsMothers with traumatic birthing

InterventionsMidwifery counselling intervention on anxiety levels of women

OutcomesLevels of anxiety, stress, depression

NotesCould not find full text. Author not answered. Not sure if this is a preventive study or if majority of included patients had a mental disorder at baseline

Bhadwal 1992

Methods3 groups, unsure if randomised

ParticipantsRural primary school students in India

InterventionsPackage of certain curricular strategies on cognitive and non-cognitive characteristics (test anxiety)

OutcomesAnxiety levels

NotesUnsure whether NSHW-delivered and of study design. No reply from authors

Blackmon 1985

MethodsUnknown

ParticipantsExplore problems in drug use by elderly people with particular emphasis on their abuse or addiction to alcohol

InterventionsA comprehensive plan for networking (community) alcoholism treatment and educational services to this underserved population a comprehensive network of services

OutcomesUnknown

NotesOnly got abstract of book chapter. Unknown if NSHW-led and which country it is in

Buttorff 2012

MethodsEconomic evaluation linked to Patel 2010 C-RCT India

ParticipantsAdults with common mental disorders in primary care settings

InterventionsCollaborative stepped care intervention

OutcomesCost-utility and cost-effectiveness

NotesWas published after the last search was performed

Caqueo-Urzar 2010

MethodsRandomised trial

ParticipantsDetermine the level of satisfaction of relatives of patients with schizophrenia in Chile

Interventions1 group comprised 18 carers who participated in a multifamily intervention programme at a mental health centre. The second group (waiting list) comprised 23 carers who would not receive any type of family intervention until the first group finished the programme

OutcomesCarer satisfaction

NotesAbstract. Not sure if care in secondary care settings. Unable to contact author

Chang 2010

MethodsUnknown

ParticipantsPatients with severe mental disorders in Taiwan

InterventionsChange from hospital-based model to community-based model

OutcomesUnknown

NotesAbstract. Unsure if meets criteria (?NSHW-led and what study design is). Author not responded

Cherpitel 2009

MethodsProtocol of an RCT

ParticipantsAt risk drinkers and dependent drinkers in Poland

InterventionsScreening, brief intervention, referral and treatment in emergency department by physicians, nurses and assistant physicians

OutcomesUnsure

NotesNot sure if this classifies as secondary care setting and cannot find the results of this trial. Attempted to contact author but no response received

Chien 2007a

MethodsRCT protocol

ParticipantsFamily carers of people with schizophrenia

InterventionsMutual support and psycho-educational group interventions

OutcomesLength of re-hospitalisations; families' perceived social support; patients' symptom severity

NotesNot sure if this is the same trial as published in 2007 (Chien WT, Wong KF, 2007. A family psychoeducation group programme for Chinese).

If not, was this done in community or hospital settings. By an NSHW? No reply from author

Farahat 2010

MethodsUnknown whether there was a control group

ParticipantsChildren with epilepsy

InterventionsIntegrated programme of epilepsy management was performed on patients, carers and school teachers

OutcomesPrevalence of epilepsy, scholastic achievements, knowledge and practice of epileptic children and their carers

NotesUnable to contact author to find out if NSHW-led intervention and if there was a control group

Hsiao 2009

MethodsRCT protocol

ParticipantsSpouse carers of resectable colorectal cancer

InterventionsCarer psychoeducational consultation programme

OutcomesShort-form 12 health-related quality of life questionnaire, Beck Depression Inventory-II depression scale

NotesWas this primary or secondary care? Was the psychoeducation programme led by NSHWs?

How many carers at baseline had a diagnosable or borderline mental disorder?

Kumar 2011

MethodsUnknown

ParticipantsPatients with schizophrenia in rural India

InterventionsUnknown

OutcomesUnknown

NotesAbstract. Unable to find paper or author

Lee 2011a

MethodsRCT

ParticipantsCarers of people with dementia in Korea

InterventionsStress management training for carers of people with dementia

OutcomesBeck Depression Inventory, Caregiver Stress Burden Interview, Life Satisfaction

NotesUnknown if NSHW-led. Author not replied

Luna 1984

MethodsUnknown

ParticipantsCocaine drug addicts

InterventionsMental health programme and pharmaco-dependence

OutcomesUnknown

NotesInsufficient information as no abstract. Unable to contact author. Email returned undelivered and no reply to telephone calls

Malakouti 2010

MethodsRCT protocol

ParticipantsPatients with schizophrenia, schizoaffective disorder and bipolar disorder

InterventionsIntervention 1: GP supervision of drug treatment, etc.; Intervnetion 2: Nurse supervision. Control: usual care (just psychiatric - no community follow-up)

OutcomesCarer's burden and knowledge. Cost of treatment, health of carer, life-skills of patients, relapse/rehospitalisation rates, severity of psychopathology

NotesNot able to find results. Author not replied

Oh 1997

Methods1 group pre-post experimental design

ParticipantsMothers of developmentally delayed children

Interventions2 series of 4-weekly meetings for group social support were conducted by the researcher with the intention of developing a self help group

OutcomesBurden, well-being of mothers

NotesCould not find full text (only abstract) and not sure if NSHW-led

Sott 1998

MethodsEvaluation (not sure of study design e.g. if ITS)

ParticipantsPatients discharged to community

InterventionsPatients receive 'community assistance'. 1 group is followed up by hospital staff, the other by private (? generalist) clinics

OutcomesPatient outcomes

NotesCannot contact author to check if correct study design and what 'community assistance' is and if NSHW-led

 
Characteristics of ongoing studies [ordered by study ID]
Ager 2011

Trial name or titleThe impact of the school-based Psychosocial Structured Activities (PSSA) program on conflict-affected children in northern Uganda

MethodsCBA study

ParticipantsChildren who have suffered trauma

InterventionsSchool based PSSA programme

OutcomesMeasures of well-being felt by parent, child and teacher

Starting date2007/2008

Contact information

NotesPublished article that was only detected recently. Appears to be a prevention study. To leave for review update

Araya 2010

Trial name or titleCluster randomised controlled trial of a school-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile

MethodsRCT (protocol)

ParticipantsDepressed children aged 13-15 years

InterventionsCognitive behavioural therapy-like intervention delivered in the class by trained research workers (psychologists, teachers, social workers, others)

OutcomesBeck Depression Inventory; Revised Child Anxiety and Depression Scale; school records of academic performance

Starting date2009

Contact informationr.araya@bris.ac.uk; www.controlled-trials.com/ISRCTN19466209

Notes

Ayoughi 2012

Trial name or titleProvision of mental health services in resource-poor settings: a randomised trial comparing counselling with routine medical treatment in North Afghanistan (Mazar-e-Sharif)

MethodsCBA study

ParticipantsMentally ill patients from primary health care (excluded were those with neurological disorders, mental retardation, dementia or schizophrenia)

InterventionsLay counsellors delivering counselling to patients

OutcomesSeverity of symptoms (HSCL-25 and MINI, stressors and coping mechanism scales

Starting date2009

Contact informationsarah.ayoughi@uni-konstanz.de

NotesThis is already published. Detected recently so decision to include in review update

Chen 2010

Trial name or titleCommunity case management for early psychosis: is two year an optimal duration? A randomized controlled study

MethodsRCT (protocol)

ParticipantsPatients with early diagnosis of psychosis in China

InterventionsCommunity case management which includes NSHWs

OutcomesFunctioning (social and occupational); symptoms, quality of life and health economics

Starting dateJuly 2010

Contact informationclinicaltrials.gov/show/NCT01202357

Notes

Chen 2011

Trial name or titleDepression care management for late-life depression in China primary care: protocol for a randomised controlled trial

MethodsRCT (protocol)

ParticipantsPatients with depression in China

InterventionsPrimary care-based intervention with physicians and care managers (nurses)

OutcomesPatient outcomes: suicidal ideation, psychopathology, medical health, cognitive function, quality of life and stigma and satisfaction for the treatment. Provider outcomes: attitudes/knowledge regarding depression and clinical practices with the treatment guidelines

Starting dateUnsure

Contact informationwww.clinicaltrials.gov/ct2/show/NCT01287494

Notes

Greenfield 2010

Trial name or titleIntegrated management of physician-delivered alcohol care for tuberculosis patients: design and implementation

MethodsRCT (protocol)

ParticipantsPeople with tuberculosis with alcohol problems in tuberculosis centres in Russia

InterventionsBrief counselling intervention with or without naltrexone delivered by the tuberculosis physicians

OutcomesPatient and physician outcomes

Starting date2010

Contact informationsgreenfield@mclean.harvard.edu

NotesStudy results not available yet

Kauye (in preparation)

Trial name or titleTraining primary health workers in mental health and its impact on service delivery in a developing country, Malawi: a cluster randomised study

MethodsCluster RCT (protocol)

ParticipantsMentally ill patient in primary care in Malawi

InterventionsCollaborative care

OutcomesPatient outcomes

Starting date2010

Contact informationrachel@olan.org

Notes

Kobeissi 2011

Trial name or titleThe Relaxation Exercise and Social Support Trial - RESST: study protocol for a randomised community based trial

MethodsRCT (protocol)

ParticipantsWomen with common mental disorders and vaginal discharge in Lebanon

InterventionsRelaxation exercises and discussion groups delivered by social workers and psychologists

OutcomesHSCL25; The Scale for Assessment of Somatic Symptoms (SASS)

Starting dateNot specified but results not out yet

Contact informationWellcome Trust Registry, www.controlled-trials.com/ISRCTN98441241

Notes

Logie 2012

Trial name or titleDevelopment and evaluation of a community health worker delivered HIV/STI prevention intervention for women living in internally displaced persons camps in Leogane, Haiti

MethodsRCT (protocol)

ParticipantsInternally displaced female adults in Haiti

InterventionsIndividual and group-based, community health worker delivered

OutcomesPrimary outcome: HIV knowledge; secondary outcomes: depression, substance abuse, resilient coping, relationship control, social support, condom use, STI knowledge

Starting dateJanuary 2012

Contact informationclinicaltrials.gov/show/NCT01492829

Notes

O'Callaghan 2012

Trial name or titleIs a family-based, life skills focused intervention effective in reducing psychological distress and stigma and improving inter-personal relations and functioning among former LRA abductees and other war-affected children in their community in Dungu, the Democratic Republic of Congo?

MethodsRCT (protocol)

ParticipantsVulnerable children with psychological distress in war-affected Democratic Republic of Congo

InterventionsFamily-focused, community-based, resilience-targeting psychosocial intervention delivered by a team of lay Congolese facilitators

OutcomesReduction in psychological distress; improvement in community, daily and family functioning

Starting dateMarch 2012

Contact informationclinicaltrials.gov/show/NCT01542398

Notes

Opoka 2008

Trial name or titleCognitive and psychosocial benefits of caregiver training for Ugandan HIV children

MethodsRCT (protocol)

ParticipantsHIV-positive children

InterventionsMediational intervention for sensitising primary carers delivered by home visitors and social scientists with minimal training in mental health

OutcomesPrimary: children's cognitive and psychosocial assessment; secondary: improved caring

Starting date2012: first year of enrolment

Contact informationclinicaltrials.gov/show/NCT00889395

NotesNeed to check if children have baseline mental disorder

 
Comparison 1. NSHW-led psychological interventions versus usual care in treating common mental disorders in adults (RCTs)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Prevalence of depression (completers)31082Risk Ratio (Random, 95% CI)0.30 [0.14, 0.64]

    1.1 Short term (within 6 months post intervention)
31082Risk Ratio (Random, 95% CI)0.30 [0.14, 0.64]

 2 Prevalence of depression (ITT sensitivity analysis - assumption non-completers depressed)3Risk Ratio (Random, 95% CI)Subtotals only

    2.1 Short term (within 6 months post intervention)
31359Risk Ratio (Random, 95% CI)0.61 [0.43, 0.84]

 3 Prevalence of depression (ITT sensitivity analysis - assumption non-completers not depressed)3Risk Ratio (Random, 95% CI)Subtotals only

    3.1 Short term (within 6 months post intervention)
31359Risk Ratio (Random, 95% CI)0.39 [0.20, 0.78]

 4 Prevalence of depression (ITT sensitivity analysis - worse-case scenario intervention group depressed; control group not depressed)3Risk Ratio (Random, 95% CI)Subtotals only

    4.1 Short term (within 6 months post intervention)
31359Risk Ratio (Random, 95% CI)1.11 [0.56, 2.21]

 5 Prevalence of depression (ITT sensitivity analysis - best-case scenario: intervention group not depressed; control group all depressed)3Risk Ratio (Random, 95% CI)Subtotals only

    5.1 Short term (within 6 months post intervention)
31359Risk Ratio (Random, 95% CI)0.20 [0.09, 0.45]

 6 Severity of common mental disorder symptoms (includes anxiety and depression)7Std. Mean Difference (Random, 95% CI)Subtotals only

    6.1 Short term (within 6 months post intervention)
61470Std. Mean Difference (Random, 95% CI)-0.75 [-1.29, -0.21]

    6.2 Medium term (1 year)
2923Std. Mean Difference (Random, 95% CI)-0.47 [-0.60, -0.34]

 7 Functional impairment/disability in common mental disorders4Std. Mean Difference (Random, 95% CI)Subtotals only

    7.1 Short term (within 6 months post intervention)
41243Std. Mean Difference (Random, 95% CI)-0.33 [-0.80, 0.13]

    7.2 Short term (advocacy empowerment physical functioning) short term (6 months post intervention)
1200Std. Mean Difference (Random, 95% CI)0.08 [-0.20, 0.36]

    7.3 Medium term (8 months post intervention)
1798Std. Mean Difference (Random, 95% CI)-0.56 [-0.70, -0.42]

 
Comparison 2. Collaborative care model (NSHWs plus specialist) versus usual care in treating common mental disorders (RCTs)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Prevalence of common mental disorders (CMDs - includes anxiety and depression) (completers-combined) all facilities and in public and private facilities3Risk Ratio (Random, 95% CI)Subtotals only

    1.1 All facilities short term (within 6 months post intervention)
32380Risk Ratio (Random, 95% CI)0.63 [0.44, 0.90]

    1.2 Public facilities short term (within 6 months post intervention) (subgroup)
31528Risk Ratio (Random, 95% CI)0.57 [0.42, 0.78]

    1.3 Private facilities short term (within 6 months post intervention) (subgroup)
1823Risk Ratio (Random, 95% CI)1.12 [0.68, 1.84]

    1.4 All facilities medium term (at 1 year post intervention)
12009Risk Ratio (Random, 95% CI)0.95 [0.68, 1.33]

    1.5 Public facilities medium term (at 1 year post intervention) (subgroup)
11104Risk Ratio (Random, 95% CI)0.72 [0.39, 1.34]

    1.6 Private facilities at 1 year post intervention
1801Risk Ratio (Random, 95% CI)1.25 [0.76, 2.06]

 2 Severity of symptoms of CMDs (completers-combined) in all facilities and in public and private facilities5Std. Mean Difference (Random, 95% CI)Subtotals only

    2.1 All facilities short term (within 6 months post intervention)
53604Std. Mean Difference (Random, 95% CI)-0.31 [-0.56, -0.06]

    2.2 Public facilities short term (within 6 months post intervention) (subgroup)
52781Std. Mean Difference (Random, 95% CI)-0.32 [-0.58, -0.07]

    2.3 Private facilities short term (within 6 months post intervention) (subgroup)
1823Std. Mean Difference (Random, 95% CI)0.03 [-0.11, 0.16]

    2.4 All facilities medium term (at 1 year post intervention)
11905Std. Mean Difference (Random, 95% CI)-0.03 [-0.12, 0.06]

    2.5 Public facilities medium term (at 1 year post intervention) (subgroup)
11104Std. Mean Difference (Random, 95% CI)-0.07 [-0.19, 0.05]

    2.6 Private facilities medium term (at 1 year post intervention) (subgroup)
1801Std. Mean Difference (Random, 95% CI)0.02 [-0.11, 0.16]

 3 Functional impairment/disability in CMD (completers- combined) all facilities and in public and private facilities (SMD)5Std. Mean Difference (Random, 95% CI)Subtotals only

    3.1 All facilities short term (within 6 months post intervention)
53604Std. Mean Difference (Random, 95% CI)-0.22 [-0.44, -0.01]

    3.2 Public facilities short term (within 6 months post intervention) (subgroup)
52781Std. Mean Difference (Random, 95% CI)-0.24 [-0.45, -0.02]

    3.3 Private facilities short term (within 6 months post intervention) (subgroup)
1823Std. Mean Difference (Random, 95% CI)0.02 [-0.12, 0.15]

    3.4 All facilities medium term (at 1 year post intervention)
11905Std. Mean Difference (Random, 95% CI)-0.02 [-0.11, 0.07]

    3.5 Public facilities medium term (at 1 year post intervention) (subgroup)
11104Std. Mean Difference (Random, 95% CI)-0.05 [-0.17, 0.07]

    3.6 Private facilities medium term (at 1 year post intervention) (subgroup)
1801Std. Mean Difference (Random, 95% CI)0.03 [-0.11, 0.17]

 4 Suicide attempt for those with CMDs all facilities and in public/private facilities (completers)1Risk Ratio (M-H, Random, 95% CI)Subtotals only

    4.1 All facilities short term (6 months post intervention)
11961Risk Ratio (M-H, Random, 95% CI)0.75 [0.29, 1.97]

    4.2 Public facilities short term (6 months post intervention)
11138Risk Ratio (M-H, Random, 95% CI)0.66 [0.32, 1.40]

    4.3 Private facilities short term (6 months post intervention)
1823Risk Ratio (M-H, Random, 95% CI)0.71 [0.12, 4.22]

    4.4 All facilities medium term (1 year post intervention)
11905Risk Ratio (M-H, Random, 95% CI)0.56 [0.24, 1.32]

    4.5 Public facilities medium term (1 year post intervention)
11104Risk Ratio (M-H, Random, 95% CI)0.78 [0.18, 3.48]

    4.6 Private facilities medium term (1 year post intervention)
1801Risk Ratio (M-H, Random, 95% CI)0.40 [0.11, 1.50]

 5 Prevalence of CMDs (only Patel - sensitivity analysis (SA)) (completers) all facilities and in public and private facilities1Risk Ratio (Random, 95% CI)Subtotals only

    5.1 All facilities short term (within 6 months post intervention)
11961Risk Ratio (Random, 95% CI)0.80 [0.61, 1.05]

    5.2 Public facilities short term (within 6 months post intervention) (subgroup)
11109Risk Ratio (Random, 95% CI)0.59 [0.41, 0.85]

    5.3 Private facilities at 6 months post intervention
1823Risk Ratio (Random, 95% CI)1.12 [0.68, 1.84]

    5.4 All facilities medium term (at 1 year post intervention)
12009Risk Ratio (Random, 95% CI)0.95 [0.68, 1.33]

    5.5 Public facilities medium term (at 1 year post intervention) (subgroup)
11104Risk Ratio (Random, 95% CI)0.72 [0.39, 1.34]

    5.6 Private facilities at 1 year post intervention
1801Risk Ratio (Random, 95% CI)1.25 [0.76, 2.06]

 6 Severity of symptoms in CMD (only Patel and Jenkins (SA)) in all facilities and in public and private facilities2Std. Mean Difference (Random, 95% CI)Subtotals only

    6.1 All facilities short term (within 6 months post intervention)
22889Std. Mean Difference (Random, 95% CI)-0.07 [-0.15, -0.00]

    6.2 Public facilities short term (within 6 months post intervention) (subgroup)
22066Std. Mean Difference (Random, 95% CI)-0.11 [-0.21, -0.00]

    6.3 Private facilities short term (within 6 months post intervention) (subgroup)
1823Std. Mean Difference (Random, 95% CI)0.03 [-0.11, 0.16]

    6.4 All facilities medium term (at 1 year post intervention)
11905Std. Mean Difference (Random, 95% CI)-0.03 [-0.12, 0.06]

    6.5 Public facilities medium term (at 1 year post intervention) (subgroup)
11104Std. Mean Difference (Random, 95% CI)-0.07 [-0.19, 0.05]

    6.6 Private facilities medium term (at 1 year post intervention) (subgroup)
1801Std. Mean Difference (Random, 95% CI)0.02 [-0.11, 0.16]

 7 Prevalence of depression (completers) (SA) all facilities and in public and private facilities3Risk Ratio (Random, 95% CI)Subtotals only

    7.1 All facilities short term (within 6 months post intervention)
31092Risk Ratio (Random, 95% CI)0.61 [0.40, 0.94]

    7.2 Public facilities short term (within 6 months post intervention) (subgroup)
3828Risk Ratio (Random, 95% CI)0.56 [0.37, 0.84]

    7.3 Private facilities short term (within 6 months post intervention) (subgroup)
1254Risk Ratio (Random, 95% CI)1.59 [0.40, 6.32]

    7.4 All facilities medium term (1 year post intervention)
1652Risk Ratio (Random, 95% CI)0.95 [0.68, 1.33]

    7.5 Public facilities medium term (1 year post intervention) (subgroup)
1398Risk Ratio (Random, 95% CI)0.72 [0.39, 1.34]

    7.6 Private facilities medium term (at 1 year post intervention) (subgroup)
1254Risk Ratio (Random, 95% CI)1.25 [0.76, 2.06]

 8 Severity of symptoms of depression (SA) in all facilities and in public and private facilities4Std. Mean Difference (Random, 95% CI)Subtotals only

    8.1 All facilities short term (within 6 months post intervention)
41388Std. Mean Difference (Random, 95% CI)-0.39 [-0.78, 0.01]

    8.2 Public facilities short term (within 6 months post intervention) (subgroup)
41124Std. Mean Difference (Random, 95% CI)-0.41 [-0.79, -0.04]

    8.3 Private facilities short term (within 6 months post intervention) (subgroup)
1254Std. Mean Difference (Random, 95% CI)0.16 [-0.09, 0.41]

    8.4 All facilities medium term (at 1 year post intervention)
1652Std. Mean Difference (Random, 95% CI)0.11 [-0.05, 0.26]

    8.5 Public facilities medium term (at 1 year post intervention) (subgroup)
1398Std. Mean Difference (Random, 95% CI)-0.09 [-0.29, 0.12]

    8.6 Private facilities medium term (at 1 year post intervention) (subgroup)
1254Std. Mean Difference (Random, 95% CI)-0.03 [-0.28, 0.22]

 9 Functional impairment/disability in CMD (SA) all facilities and in public and private facilities (SMD)2Std. Mean Difference (Random, 95% CI)Subtotals only

    9.1 All facilities short term (within 6 months post intervention)
22889Std. Mean Difference (Random, 95% CI)-0.03 [-0.10, 0.04]

    9.2 Public facilities short term (within 6 months post intervention) (subgroup)
22066Std. Mean Difference (Random, 95% CI)-0.06 [-0.15, 0.02]

    9.3 Private facilities short term (within 6 months post intervention) (subgroup)
1823Std. Mean Difference (Random, 95% CI)0.02 [-0.12, 0.15]

    9.4 All facilities medium term (at 1 year post intervention)
11905Std. Mean Difference (Random, 95% CI)-0.02 [-0.11, 0.07]

    9.5 Public facilities medium term (at 1 year post intervention) (subgroup)
11104Std. Mean Difference (Random, 95% CI)-0.05 [-0.17, 0.07]

    9.6 Private facilities medium term (at 1 year post intervention) (subgroup)
1801Std. Mean Difference (Random, 95% CI)0.03 [-0.11, 0.17]

 10 Functional impairment/disability in CMD (SA) all facilities and in public and private facilities (MD)2Mean Difference (Random, 95% CI)Subtotals only

    10.1 All facilities short term (within 6 months post intervention)
22889Mean Difference (Random, 95% CI)-0.53 [-2.06, 1.01]

    10.2 Public facilities short term (within 6 months post intervention) (subgroup)
22066Mean Difference (Random, 95% CI)-1.24 [-2.94, 0.46]

    10.3 Private facilities short term (within 6 months post intervention) (subgroup)
1823Mean Difference (Random, 95% CI)0.35 [-2.39, 3.09]

    10.4 All facilities medium term (at 1 year post intervention)
11905Mean Difference (Random, 95% CI)-0.41 [-2.37, 1.55]

    10.5 Public facilities medium term (at 1 year post intervention) (subgroup)
11104Mean Difference (Random, 95% CI)-1.49 [-4.93, 1.95]

    10.6 Private facilities medium term (at 1 year post intervention) (subgroup)
1801Mean Difference (Random, 95% CI)0.83 [-2.32, 3.98]

 11 Functional impairment/disability in depression (SA) all facilities and in public and private facilities4Std. Mean Difference (Random, 95% CI)Subtotals only

    11.1 All facilities short term (within 6 months post intervention)
43144Std. Mean Difference (Random, 95% CI)-0.29 [-0.62, 0.04]

    11.2 Public facilities short term (within 6 months post intervention) (subgroup)
42131Std. Mean Difference (Random, 95% CI)-0.31 [-0.62, 0.00]

    11.3 Private facilities short term (at 6 months post intervention) (subgroup)
11013Std. Mean Difference (Random, 95% CI)0.06 [-0.18, 0.31]

    11.4 All facilities medium term (at 1 year post intervention)
12367Std. Mean Difference (Random, 95% CI)-0.07 [-0.23, 0.09]

    11.5 Public facilities medium term (at 1 year post intervention) (subgroup)
11416Std. Mean Difference (Random, 95% CI)-0.09 [-0.29, 0.12]

    11.6 Private facilities medium term (at 1 year post intervention) (subgroup)
1981Std. Mean Difference (Random, 95% CI)-0.02 [-0.27, 0.23]

 
Comparison 3. NSHWs versus usual care in treating maternal depression (RCTs)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Severity of symptoms in treating maternal depression41213Std. Mean Difference (Random, 95% CI)-0.42 [-0.58, -0.26]

    1.1 NSHW-led interventions short term (within 3 months post intervention)
2858Std. Mean Difference (Random, 95% CI)-0.50 [-0.63, -0.36]

    1.2 Collaborative care short term (at 3 months post intervention)
1230Std. Mean Difference (Random, 95% CI)-0.22 [-0.48, 0.04]

    1.3 NSHW-led intervention medium term (at 1 year post intervention)
1125Std. Mean Difference (Random, 95% CI)-0.41 [-0.76, -0.06]

 
Comparison 4. NSHWs versus specialists in treating depression in adults (controlled before-and-after studies)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Severity of depression short term (2 months post intervention)1768Mean Difference (IV, Random, 95% CI)-0.90 [-1.20, -0.60]

 2 Frequency of adverse events1768Risk Ratio (M-H, Random, 95% CI)0.85 [0.67, 1.07]

 3 Number of days spent in hospital1Mean Difference (IV, Random, 95% CI)Subtotals only

    3.1 Outcomes at 1 year
1124Mean Difference (IV, Random, 95% CI)-1.79 [-3.59, 0.01]

    3.2 Outcomes at 2 years
1124Mean Difference (IV, Random, 95% CI)-0.02 [-2.59, 2.55]

 4 Number of days spent on sick leave1Mean Difference (IV, Random, 95% CI)Subtotals only

    4.1 Outcome at 1 year
1108Mean Difference (IV, Random, 95% CI)-3.96 [-15.58, 7.66]

    4.2 Outcome at 2 years
1123Mean Difference (IV, Random, 95% CI)14.63 [-0.76, 30.02]

 
Comparison 5. NSHW-led psychological interventions versus usual care in treating adults with post-traumatic stress disorder (RCT and NRCT)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Prevalence of post-traumatic stress disorder (PTSD)1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 LHW-led narrative exposure therapy short term (6 months post intervention)
162Risk Ratio (M-H, Fixed, 95% CI)0.48 [0.27, 0.85]

    1.2 LHW-led trauma counselling short term (6 months post intervention)
165Risk Ratio (M-H, Fixed, 95% CI)0.55 [0.33, 0.93]

 2 Severity of PTSD symptoms3Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    2.1 Short term LHW-led counselling with PTSD psychoeducation (6 months post intervention)
3223Std. Mean Difference (IV, Random, 95% CI)-0.36 [-0.67, -0.05]

    2.2 Short term (Yeomans second arm) (2 weeks post intervention)
175Std. Mean Difference (IV, Random, 95% CI)-0.44 [-0.90, 0.02]

    2.3 Short term (Neuner first arm - narrative exposure therapy) (6 months post intervention)
175Std. Mean Difference (IV, Random, 95% CI)-0.55 [-1.08, -0.03]

 3 Severity of depression1Mean Difference (IV, Random, 95% CI)Subtotals only

    3.1 LHW-led workshop with psychoeducation short term (2 weeks post intervention)
176Mean Difference (IV, Random, 95% CI)-0.07 [-0.36, 0.22]

    3.2 LHW-led workshop without psychoeducation short term (2 weeks post intervention)
175Mean Difference (IV, Random, 95% CI)-0.14 [-0.42, 0.14]

 
Comparison 6. NSHWs versus usual care in improving dementia patients' and carers' outcomes (RCTs)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Severity of behavioural problem (patient)2134Std. Mean Difference (Random, 95% CI)-0.26 [-0.60, 0.08]

 2 Patient functional ability181Mean Difference (Random, 95% CI)-0.24 [-0.67, 0.20]

 3 Patient quality of life153Mean Difference (Random, 95% CI)-0.43 [-0.98, 0.12]

 4 Carer mental health status2134Std. Mean Difference (Random, 95% CI)-0.42 [-0.76, -0.08]

 5 Carer burden2134Std. Mean Difference (Random, 95% CI)-0.50 [-0.84, -0.15]

 6 Carer distress2134Std. Mean Difference (Random, 95% CI)-0.47 [-0.82, -0.13]

 7 Carer quality of life153Mean Difference (Random, 95% CI)-0.37 [-0.92, 0.17]

 
Comparison 7. NSHW-led brief alcohol interventions versus usual care for adults with alcohol-use disorders (RCTs)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Amount of alcohol consumed (MD)2167Mean Difference (Random, 95% CI)-1.68 [-2.79, -0.57]

 2 Frequency of binge drinking192Mean Difference (IV, Random, 95% CI)-0.50 [-1.14, 0.14]

 3 Adverse consequences2160Risk Ratio (M-H, Random, 95% CI)0.77 [0.11, 5.29]

    3.1 Road traffic accidents
192Risk Ratio (M-H, Random, 95% CI)0.36 [0.12, 1.08]

    3.2 Withdrawal symptoms
168Risk Ratio (M-H, Random, 95% CI)2.67 [0.29, 24.37]

 
Comparison 8. NSHWs/OPHRs versus usual care in conducting interventions for children with post-traumatic stress and depression (RCTs)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Severity of PTSD symptoms - teacher/LHW-led interventions (SMDs)3Std. Mean Difference (Random, 95% CI)Subtotals only

    1.1 Short term (within 6 months post intervention)
3298Std. Mean Difference (Random, 95% CI)-0.89 [-1.49, -0.30]

    1.2 Short term (Ertl second arm) (5 months post intervention)
151Std. Mean Difference (Random, 95% CI)-0.12 [-0.67, 0.44]

    1.3 Medium term (Ertl first arm) (11 months post intervention)
153Std. Mean Difference (Random, 95% CI)-0.45 [-0.99, 0.10]

    1.4 Medium term (Ertl second arm) (11 months post intervention)
151Std. Mean Difference (Random, 95% CI)-0.04 [-0.59, 0.52]

 2 Severity of PTSD symptoms - classroom-based LHW interventions (MCDs)3Mean Change Difference (Random, 95% CI)Subtotals only

    2.1 Short term (within 6 months post intervention)
31090Mean Change Difference (Random, 95% CI)-0.56 [-2.82, 1.70]

 3 Severity of PTSD symptoms - classroom-based LHW interventions - boys/girls1399Mean Change Difference (Random, 95% CI)1.40 [-1.58, 4.37]

    3.1 Short term (boys) (within 6 months post intervention)
1245Mean Change Difference (Random, 95% CI)0.0 [-2.02, 2.02]

    3.2 Short term (girls) (within 6 months post intervention)
1154Mean Change Difference (Random, 95% CI)3.05 [0.39, 5.71]

 4 Severity of depressive symptoms - teacher/LHW-led interventions (SMDs)4Std. Mean Difference (Random, 95% CI)Subtotals only

    4.1 Short term (within 6 months post intervention)
4504Std. Mean Difference (Random, 95% CI)-0.23 [-0.45, -0.02]

    4.2 Short term (Bolton second arm) (6 months post intervention)
1209Std. Mean Difference (Random, 95% CI)0.08 [-0.20, 0.35]

    4.3 Short term (Ertl second arm) (5 months post intervention)
151Std. Mean Difference (Random, 95% CI)0.03 [-0.52, 0.58]

    4.4 Medium term (Ertl first arm) (11 months post intervention)
153Std. Mean Difference (Random, 95% CI)0.02 [-0.52, 0.56]

    4.5 Medium term (Ertl second arm) (11 months post intervention)
151Std. Mean Difference (Random, 95% CI)0.17 [-0.38, 0.72]

 5 Severity of depressive symptoms - classroom-based LHW interventions (MCDs)3Mean Change Difference (Random, 95% CI)Subtotals only

    5.1 Short term (within 6 months post intervention)
31092Mean Change Difference (Random, 95% CI)-0.18 [-0.33, -0.03]

 6 Severity of depressive symptoms (MCDs) Tol 2012 boys/girls1399Mean Change Difference (Random, 95% CI)0.27 [-0.58, 1.12]

    6.1 Short term (boys) (within 6 months post intervention)
1245Mean Change Difference (Random, 95% CI)-0.02 [-1.18, 1.14]

    6.2 Short term (girls) (within 6 months post intervention)
1154Mean Change Difference (Random, 95% CI)0.61 [-0.63, 1.85]

 7 Severity of anxiety symptoms - classroom-based intervention (within 6 months post intervention)31092Mean Change Difference (Random, 95% CI)-0.34 [-0.75, 0.07]

    7.1 Short term (within 6 months post intervention)
31092Mean Change Difference (Random, 95% CI)-0.34 [-0.75, 0.07]

 8 Severity of anxiety symptoms - classroom-based intervention - boys/girls1399Mean Change Difference (Random, 95% CI)-0.22 [-1.09, 0.65]

    8.1 Short term (boys) (within 6 months post intervention)
1245Mean Change Difference (Random, 95% CI)-0.63 [-1.23, -0.03]

    8.2 Short term (girls) (within 6 months post intervention)
1154Mean Change Difference (Random, 95% CI)0.26 [-0.53, 1.05]

 9 Functional impairment teacher/LHW-led interventions2Std. Mean Difference (Random, 95% CI)Subtotals only

    9.1 Short term (within 6 months post intervention)
2220Std. Mean Difference (Random, 95% CI)-0.61 [-1.13, -0.08]

    9.2 Medium term (11 months post intervention)
153Std. Mean Difference (Random, 95% CI)-0.69 [-1.25, -0.14]

 10 Functional impairment LHW-led - classroom-based intervention3Mean Change Difference (Random, 95% CI)Subtotals only

    10.1 Short term (within 6 months post intervention)
31092Mean Change Difference (Random, 95% CI)-0.81 [-1.48, -0.13]

 11 Functional impairment - classroom-based LHW intervention - boys/girls1399Mean Difference (Random, 95% CI)-0.94 [-1.80, -0.08]

    11.1 Short term (boys) (within 6 months post intervention)
1245Mean Difference (Random, 95% CI)-1.19 [-2.23, -0.15]

    11.2 Short term (girls) (within 6 months post intervention)
1154Mean Difference (Random, 95% CI)-0.40 [-1.93, 1.13]

 
Summary of findings for the main comparison. NSHW-led psychological interventions compared with usual care in treating depression in adults in low- and middle-income countries (RCTs)

What are the effects of NSHW-led psychological interventions for treating depression in adults in low- and middle-income countries?

Patient or population: Adults with depression
Settings: Low- and middle-income countries (Taiwan, Pakistan, Uganda)
Intervention: NSHWs conducting psychological interventions
Comparison: Usual care

OutcomesIllustrative comparative risks* (95% CI)Effect estimate
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual care NSHWs

Prevalence of depression (adults), short term (0-8 weeks)
measured using various depression rating scales1
300 per 100091 per 1000RR 0.30
(0.14 to 0.64)
1082
(3 studies)
⊕⊕⊝⊝
low2,3
-

*The basis for the assumed risk is the mean control group risk across studies for pooled results and the control group risk for single studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; DSM: Diagnostic and Statistical Manual of Mental Disorders; NSHW: non-specialist health worker; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Bolton 2003 C-RCT Uganda: DSM-IV criteria A, C and E; Rahman 2008 CRCT Pakistan: Hamilton Depression Rating scale; Chen 2000 RCT Taiwan: Taiwanese Beck Depression Inventory.
2 Serious study limitations: Two of the three studies were at risk of bias. Bolton 2003 C-RCT Uganda was judged unclear for allocation concealment, and quasi-randomisation of individuals within clusters (though randomisation was in clusters) could have introduced bias; Chen 2000 RCT Taiwan was unclear for sequence generation and allocation concealment, all outcomes were self reported, there was possible contamination and the dropout rate after randomisation was high, with no analysis of differences in dropouts versus non-dropouts. These two studies contributed 62% of the weight in the pooled analysis. Downgraded by 1.
3Serious inconsistency: I2 was 81%. However, the inconsistency related to the magnitude of benefit favouring collaborative care rather than in the direction of effect. Downgraded by 1.
 
Summary of findings 2. Collaborative care model (NSHWs plus specialist) compared with usual care in treating common mental disorders in adults in low- and middle-income countries (RCTs)

What are the effects of a collaborative care model (NSHW plus specialist supervision) for mental health care in adults with common mental disorders low- and middle-income countries?

Patient or population: Adults (≥ 18 years) with CMDs (includes anxiety or depression, or both)
Settings: Middle-income countries (Chile, India)
Intervention: Collaborative care model (NSHW plus specialist supervision)

Comparison: Enhanced usual care

OutcomesIllustrative comparative risks* (95% CI)Effect estimate
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual careCollaborative care model

Prevalence of CMDs, short term (2-6 months)
measured using various CMD/depression rating scales1
205 per 1000140 per 1000RR 0.63
(0.44 to 0.90)
2380
(3 studies)
⊕⊕⊝⊝
low2,3
In Patel 2010 C-RCT India; collaborative care reduced the prevalence of CMDs at 6 months in a subgroup of people treated at public health facilities (RR 0.57, 95% CI 0.42 to 0.78; 1528 participants). This effect was not seen in people treated at private facilities (RR 1.12, 95% CI 0.68 to 1.84; 823 participants)

*The basis for the assumed risk is the mean control group risk across studies for pooled results and the control group risk for single studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; CIS: Clinical Interview Schedule; CMD: common mental disorder; EPDS: Edinburgh Postnatal Depression Scale; GP: general practitioner; HDRS: Hamilton Depression Rating Scale; ICD: International Classification of Diseases; NSHW: non-specialist health worker; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Araya 2003 RCT Chile: HDRS; Patel 2010 C-RCT India: CIS-R generated ICD-10 diagnosis for CMD; Rojas 2007 RCT Chile: EPDS with a 6-point reduction in score indicating recovery.
2Serious study limitations: In Araya 2003 RCT Chile, GPs provided both intervention and control treatments, so there was a high risk of contamination. Downgraded by 1.
3Serious inconsistency: I2 was 79% with Araya 2003 RCT Chile clearly an outlier, contributing to this unexplained inconsistency. However, the inconsistency related to the magnitude of benefit favouring collaborative care rather than in the direction of effect. Downgraded by 1.
 
Summary of findings 3. NSHWs compared with usual care for treating maternal depression (RCTs)

What are the effects of NSHW-led interventions for treating maternal depression in low- and middle-income countries?

Patient or population: Adult women with maternal depression
Settings: Low- and middle-income countries (Chile, Jamaica, Pakistan, Taiwan)
Intervention: NSHW-led interventions
Comparison: Usual care

OutcomesIllustrative comparative risks* (95% CI)Estimate effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual careNSHWs

Severity of symptoms of perinatal depression, (short and medium term: 0-12 months)
measured using various depression rating scales1
-The mean severity of symptoms of perinatal depression - medium term with NSHW-led interventions was
0.42 standard deviations lower
(0.58 to 0.26 lower)
SMD -0.42 (-0.58 to -0.26)1213
(4 studies)
⊕⊕⊝⊝
low2,3
Note that a small clinically appreciable benefit was set at SMD < 0.2, and a moderate benefit at SMD of 0.5 to 0.8 (Cohen 1988)

*The basis for the assumed risk is the mean control group risk across studies for pooled results and the control group risk for single studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
BDI: Becks Depression Inventory; CES-D: Center for Epidemiologic Studies Depression Scale; CI: confidence interval; EPDS: Edinburgh Postnatal Depression Scale; HDRS: Hamilton Depression Rating Scale; NSHW: non-specialist health worker; RCT: randomised controlled trial; SMD: standardised mean difference.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Baker-H 2005 CRCT Jamaica CES-D; Chen 2000 RCT Taiwan Taiwanese BDI; Rahman 2008 CRCT Pakistan: HDRS; Rojas 2007 RCT Chile: EPDS.
2 Serious study limitations: Baker-H 2005 CRCT Jamaica; Chen 2000 RCT Taiwan has study limitations and together contributed 24% weight to the pooled estimates. Removal of these trials altered the results to favour NSHW-led interventions strongly. Downgraded by 1.
3 Serious imprecision: The 95% CI of the SMD indicated appreciable and non-appreciable benefit for NSHW-led interventions. Downgarded by 1.
 
Summary of findings 4. NSHWs compared with specialists in treating depression in adults in low- and middle-income countries (CBAs)

What are the effects of NSHWs compared with specialists in treating depression for mental health care in low- and middle-income countries?

Patient or population: Adults with depression
Settings: Middle-income countries (Hungary and Argentina)

Intervention: NSHWs providing pharmacological intervention
Comparison: Specialists providing pharmacological intervention

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Specialists NSHWs

Severity of depression, short term (0-56 days)
measured using HDRS
Follow-up: 56 days
The mean score (SD) on the HDRS was 9.6 (2.1)The mean severity of depression - short term (2 months post intervention) in the NSHW group was
0.9 lower
(1.2 to 0.6 lower)
MD -0.90 (-1.20 to -0.60)768
(1 study)
⊕⊝⊝⊝
very low1,2
Note that a small clinically appreciable benefit was set at SMD < 0.2, and a moderate benefit at SMD of 0.5 to 0.8 (Cohen 1988)

*The basis for the assumed risk is the risk in the control group. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CBA: controlled before-and-after; CI: confidence interval; HDRS: Hamilton Depression Rating Scale; MD: mean difference; NSHW: non-specialist health worker; RR: risk ratio; SD: standard difference; SMD: standardised mean difference.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Very serious study limitations: Lyketsos1999CBA Argentina was a CBA study so selection bias was likely. There was a risk of contamination and outcome assessments were done by same physicians doing the intervention. Downgraded by 2.
2 Serious imprecision: The MD on the HDRS was < 1 point and this is not clinically a meaningful difference on the HDRS; and the 95% CI of the MD indicated only non-appreciable benefits with NSHW intervention versus specialist intervention. However, the data came from only one study, so estimate is imprecise. Downgraded by 1.
 
Summary of findings 5. NSHW-led psychological interventions compared with usual care in treating adults with PTSD (NRCT)

What are the effects of NSHWs compared with usual mental health care in low- and middle-income countries for data from an NRCT in adults with PTSD?

Patient or population: Adults with PTSD

Settings: Low- and middle-income countries (Bosnia, Burundi, Uganda)
Intervention: NSHWs and OPHRs delivering psychological interventions (narrative exposure therapy, trauma counselling and workshops with psychoeducation)
Comparison: Usual care

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual careNSHWs/OPHRs

Severity of PTSD symptoms in LHW/teacher-led psychological interventions (trauma counselling, workshop with psychoeducation, mother intervention) in the short term (2 weeks to 6 months)
measured using various PTSD symptom scales1
The mean severity of PTSD with psychological interventions in the short term (within 6 months post-intervention) was
0.36 standard deviations lower
(0.67 to 0.05 lower)
SMD -0.36 (-0.67 to -0.05)223
(3 studies)
⊕⊕⊝⊝
low2,3

*The basis for the assumed risk is the median control group risk or mean control group risk across studies for pooled estimates and the control group risk for single studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; LHW: lay health workers; NRCT: non-randomised controlled trial; NSHW: non-specialist health worker; OPHR: other professionals with health roles; PTSD: post-traumatic stress disorder; SMD: standardised mean difference.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Neuner 2008 NRCT Uganda: Post-traumatic Stress Diagnostic Scale; Yeomans 2010 RCT Burundi: Harvard Trauma Questionnaire; Dybdahl 2001 RCT Bosnia: Impact of Events Scale.
2Serious study limitations: Neuner 2008 NRCT Uganda no allocation concealment, randomisation had no sequence generation. High dropout rate and different between groups, different baseline characteristics and likely contamination; Yeomans 2010 RCT Burundi: unvalidated Harvard Trauma Questionnaire in the local context (only validated in Burundi) so may affect reliability of outcomes. Dybdahl 2001 RCT Bosnia: incomplete outcome reporting, Impact of Events Scale not previously validated in this setting. Downgraded by 1.
3Serious imprecision: The 95% CI of the effect estimates demonstrated appreciable and non-appreciable benefit with NSHW care. Downgraded by 1.
 
Summary of findings 6. NSHWs compared with usual care in improving dementia patients' and carers' outcomes in low- and middle-income countries (RCTs)

What are the effects of NSHW-led care in improving dementia patients' and carers' outcomes for mental health care in low- and middle-income countries?

Patient or population: People with dementia and their carers
Settings: Middle-income countries (India, Russia)
Intervention: NSHWs delivering brief intervention
Comparison: Usual care

OutcomesIllustrative comparative risks* (95% CI)Estimate effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual care NSHWs

Severity of patient behavioural problems, short term (6 months)
measured using the behavioural symptom scale (NPI-S)
The mean severity of patient behavioural problems with this brief carer intervention was
0.26 standard deviations lower
(0.60 lower to 0.08 higher)
SMD -0.26 (-0.60 to 0.08)134
(2 studies)
⊕⊕⊕⊝
moderate 1,2
Note that a small clinically appreciable benefit was set at SMD < 0.2, and a moderate benefit at SMD of 0.5-0.8 (Cohen 1988)

*The basis for the assumed risk is the mean control group risk across studies for pooled results and the control group risk for single studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; NPI-S: Neuropsychiatric Inventory - Severity; NSHW: non-specialist health worker; RCT: randomised controlled trial; SMD: standardised mean difference.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 No serious study limitations: Gavrilova 2009 RCT Russia was unclear whether allocation concealed. Dias 2008 RCT India was at low risk of bias and contributed > 60% of the weight to the pooled estimates. Removal of the former study did not alter the results. Not downgraded.
2 Serious imprecision: The 95% CI for the pooled estimates indicates appreciable benefit for NSHW care and non-appreciable benefit for usual care. Downgraded by 1.
 
Summary of findings 7. NSHW-led brief alcohol interventions compared with usual care for adults with alcohol-use disorders (RCTs)

What are the effects of NSHWs in delivering brief alcohol interventions in RCTs for alcohol-use disorders?

Patient or population: People with alcohol-use disorders
Settings: Low- and middle-income countries (Thailand, Kenya)
Intervention: NSHWs in delivering brief alcohol interventions
Comparison: Usual care

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual care NSHWs

Amount of alcohol consumed, short term (3-6 months)
measured using the number of drinks/drinking day (in past week to 30 days)
The mean amount of alcohol consumed in the intervention groups was 1.68 lower (2.79 lower to 0.57 lower)MD -1.68 (-2.79 to -0.57)167
(2 studies)
⊕⊕⊝⊝
low1,2

*The basis for the assumed risk is the mean control group risk across studies for pooled data or the control group risk for individual studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; NSHW: non-specialist health worker; RCT: randomised controlled trial; RR: risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Serious study limitations: Noknoy 2010 RCT Thailand: high dropout rate with no information on whether they are different to completers, no validated tools in the setting, so unreliable primary outcomes. Papas 2011 RCT Kenya: unclear about whether the non-blinding of outcome assessors would have impacted on study. Downgraded by 1.
2 Serious imprecision: The 95% CI of the MD in number of drinks indicates marginal benefit and no appreciable benefit with interventions. The sample size was also low. Downgraded by 1.
 
Summary of findings 8. NSHWs/OPHRs compared with usual care in conducting interventions for children with post-traumatic stress disorder and depression (RCTs)

What are the effects of NSHWs/OPHRs conducting interventions for children with PTSD from RCTs in low- and middle-income countries?

Patient or population: Children/adolescents with PTSD and related depressive/anxiety symptoms
Settings: Low- and middle-income countries (Bosnia, Kosovo, Sri Lanka)
Intervention: NSHWs/OPHRs delivering psychological and psychosocial interventions

Comparison: Usual care

OutcomesIllustrative comparative risks* (95% CI)Estimate effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual careNSHWs/OPHRs

Severity of PTSD symptoms in LHW/teacher-led interventions, short term (1-6 months)
measured using various PTSD severity of symptom scales1
The mean severity of PTSD symptoms in children in teacher-led intervention groups was
1.2 standard deviations lower
(1.52 to 0.88 lower)
SMD -0.89 (-1.49 to -0.30)298
(3 studies)
⊕⊝⊝⊝
very low2,3
Note that a small clinically appreciable benefit was set at SMD < 0.2, a moderate benefit at SMD of 0.5-0.8, and a large benefit > 0.8 (Cohen 1988)

*The basis for the assumed risk the mean control group risk across studies for pooled results and the control group risk for single studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; LHW: lay health workers; NSHW: non-specialist health worker; OPHR: other professionals with health roles; PTSD: post-traumatic stress disorder; RCT: randomised controlled trial; SMD: standardised mean difference; UCLA: University of California at Los Angeles.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Berger2009 CRCT SriLanka: UCLA PTSD scale; Gordon 2008 RCT Kosovo: Harvard Trauma Questionnaire; Ertl 2011 RCT Uganda: Clinician-administered PTSD scale (CAPS).
2 Very serious study limitations: Gordon 2008 RCT Kosovo no allocation concealment, also likely contamination, and no blinding of outcome assessments; Berger2009 CRCT SriLanka no allocation concealment, likely contamination and outcomes not adjusted for clustering. Two of the three trials are at risk of bias and contribute to > 60% weight to the pooled results. Downgraded by 2.
3 Serious inconsistency: I2 = 78%. The inconsistency is not related to the direction of effect. Downgraded by 1.
 
Table 1. Definitions

AdultPatients who were ≥ 18 years old. However, if some studies had an age range from, for example, 16 years upwards and the majority of participants are over 18 years, we included these study participants as adults.

Children and adolescentsChildren (from birth to 18 years) were considered as a separate group of participants as they have 1. different patterns of psychopathology/mental disorders; 2. different help-seeking behaviours that would, therefore, require different interventions, in different settings (e.g. schools) and a different approach to careworker interventions (such as teacher-led interventions).

Mental, neurological and substance-abuse (MNS) disorders This review included MNS disorders as defined by any criteria within included papers. For the purpose of subgroup analysis, we subcategorised these disorders using the International Classification of Diseases (ICD)-10 criteria for mental and behavioural disorders and epilepsy in adults (the related ICD-10 code is listed in brackets). These categories are most likely to be used in LMIC mental health service delivery, and are based on Patel's classification (Patel 2003c), and the World Health Organization (WHO) MNS disorder categorisation (WHO 2008)

1. Common mental disorders

Mild to moderate mood (affective) disorders (F32-38)

Neurotic, stress-related and somatoform disorders  (F40-49)

Behavioural syndromes associated with physiological disturbances and physical factors (F50-59)

2. Severe mental disorders

Schizophrenia, schizotypal and delusional disorders (F20-F29)

Bipolar affective disorder (F31)

Severe depressive episode with/without psychosis (F32.2, F32.3)

3. Neuropsychiatric disorders

Organic, including symptomatic, mental disorders (includes dementia) (F1-9)

Mental retardation (F70-79)

Epilepsy (G40)

4. Disorders caused by substance abuse

Mental and behavioural disorders due to psychoactive substance use (F10-19)

5. Mental disorders specifically related to childhood/development

Conduct disorders

Developmental disorders

Eating disorders

Pervasive developmental disorders

The diagnosis could be made in clinical practice or in the context of the trial.

First level care, primary care and communityFirst level of contact with formal health services were community-based interventions or  primary care interventions (or both), on their own or attached to hospital settings, provided they had no specialist input apart from supervision (modified from Wiley-Exley 2007). This would include individuals with mental illness living in the community and programmes in outpatient clinics or primary care practices. This would not include programmes in hospitals unless the programmes in the hospitals were providing care to outpatients (i.e. generalists in outpatient departments).

Community: as mentioned above detection of mental disorders in all age groups were often done outside the health facility, for example through school, training and other community settings. Therefore, we considered interventions outside the health sector.

Low- and middle-income country (LMIC)Any country that has ever been an LMIC, as defined by the World Bank lists of LMICs

Non-specialist health workers (NSHWs)Health workers who were not specialised in MNS disorders or have not received in-depth professional specialist training in this clinical area. These included doctors, nurses, auxiliary nurses, lay health workers, as well as allied health personnel such as social workers, occupational therapists. This category did not include professional specialist health workers such as psychiatrists, neurologists, psychiatric nurses or mental health social workers. For inclusion, NSHWs received some training in MNS disorders (in either the control or the intervention group), but this would not constitute a professional category. The authors made a judgement of what constitutes 'some training'. Examples of 'some training' may be an undergraduate module or a short course in mental health.

Other professionals with health roles (OPHRs)People who were involved as community-level workers but were not within the health sector, as many people, particularly adolescents and young adults, have low contact with health workers. This category included teachers/trainers/support workers from schools and colleges, and other volunteers or workers within community-based networks or non-governmental organisations. These OPHRs have an important role particularly in the promotion of mental health and detection of mental disorders (Patel 2007c; Patel 2008a; WHO 2003a)

We excluded studies that looked at informal care provided by family members or extended members only to members of his or her own family (i.e. who were unavailable to other members of the community) from this review. As previously highlighted in Lewin;s Cochrane review, "these interventions are qualitatively different from other LHW [lay health worker] interventions included in this review given that parents or spouses have an established close relationship with those receiving care which could affect the process and effects of the intervention" (Lewin 2010).

Clinical interventions1. Detection (recognition and diagnosis) of illness, including screening

2. Acute interventions: drug treatment, non-drug treatment/care (such as specific psychological therapies, or interventions with psychosocial components like counselling, psychoeducation, coping skills, etc.), referral

3. Follow-up, rehabilitation

Service interventionsThese include change in staffing, or change in mechanism of mental health service delivery (e.g. extension of mental health services through camps and such other outreach services, mobile vans, etc.).

 
Table 2. Risk of bias economic studies - CHEC list criteria

StudyRisk of bias issues

Araya 2003 RCT Chile- time horizon < 1 year

- a societal perspective would have been more appropriate

- not all relevant costs reported

- not all relevant outcomes included (only ambulatory, not hospital)

- no discounting

Jordans 2010 C-RCT Nepal- no discounting

- no sensitivity analysis

- not all important variables listed

- no discussion of ethical/distributional issues

Zambori 2002 CBA Hungary- the competing alternatives were not described

- time horizon at 1 year was not appropriate (needs to be longer)

- not all relevant outcomes assessed (e.g. effect of treatment on severity, number of healthcare visits to psychiatrist)

- outcomes not measured appropriately (self reporting meant low response; standard prices used may not reflect actual prices)

- outcomes not valued (only the short-term outcome)

- no sensitivity analysis

- conclusions do not all follow from results

 
Table 3. Outcomes of studies not assigned to meta-analyses

Study, and outcomes measured and toolsIntervention data [no. of participants]Control dataMeasure of effect (95% CI)P valueAuthors' conclusions

Brown 2009 CBA Rwanda(depression in youth)Mentoring programme by LHWUsual care---

Severity of depression at 2 years (mean) measured using CID-SMean

[no. of participants]

23.27

[347]
Mean

[no. of participants]

23.28

[345]
-0.99Reduction in intervention group but not in control group (at baseline higher score in intervention group). However, the score indicates continuing levels of depression in both groups

Levels of marginalisation at 2 years (mean) measured using a non-validated marginalisation scale3.353.13--Improved scores in intervention group, which are no different to control group

Levels of grief at 2 years (mean) measured using a non-validated 7 point grief scale3.423.38--Baseline lower levels of grief in the control group. No change at the end of the intervention though grief increased in control group and remained stable in the intervention group

Li 1989 RCT China(epilepsy - adults and children)Village doctorsPsychiatrists---

Effective epilepsy control with phenobarbital after 3 monthsNo. seizures/month

[no. of participants]

12

[20]
No. seizures/month

[no. of participants]

11

[20]
---

Total number of adverse events after 3 monthsNo. events

[no. of participants]

19

[20]
No. events

[no. of participants]

39

[20]
---

Paranthaman2010CBAMalaysi(people with schizophrenia and their carers)Medical assistants/nursesUsual careMD (95% CI)PvalueAuthors' conclusions

Carer burden (activities in daily living) (mean) at 6 months. Measured using the Family Burden Interview scheduleMean (SD)

[no. of participants]

9.41 (3.99)

[54]
Mean (SD)

[no. of participants]

8.93 (4.47)
0.48 (-1.11 to 2.07)0.55Mostly there are similar scores between control and intervention groups.

Carer assistance in daily living severity - ADL at 6 months
measured using the Family Burden Interview Schedule
--0.83 (-0.94 to 2.60)--

Re-admission ratesNo. (events)

[no. of participants]

3

[54]
No. (events)

[no. of participants]

5

[55]
-0.47-

Defaulting from follow-upNo. (events)

[no. of participants]

6

[54]
No. (events)

[no. of participants]

14

[55]
-0.03important improvement in follow-up rate for intervention group

Shin 2009 RCT Vietnam(children with intellectual disabilities)Teacher-led portage programme (OPHRs)Usual careMD (95% CI)P valueAuthors' conclusions

Functional impairment (motor skills) at 6 months (similar at 12 months) measured using the Vineland Adaptive Behaviour ScalesMean (SD)

[no. of participants]

47.6 (16.8)

[16]
Mean (SD)

[no. of participants]

49 (15.4)

[14]
-1.40 (-12.93 to 10.13)0.81No significant difference for any mental outcomes but some improvement for motor and personal care outcomes if looked at time x effect interaction)

Functional impairment (social skills) at 6 months (similar at 12 months) measured using the Vineland Adaptive Behaviour Scales47.1 (15.5)

[16]
46.3 (18.3)

[14]
0.80 (-11.51 to 13.11)0.93-

Behavioural changes at 6 months (similar at 12 months) measured using the Vineland Adaptive Behaviour Scales55.6 (10.5)

[16]
55.7 (10)

[14]
-0.10 (-7.44 to 7.24)0.98-

Sutcliffe2009RCT Thailand(people with drug abuse disorder)Peer educator-led psychoeducation (LHWs)Usual care (life skills training)RR/MD (95% CI)P valueAuthors' conclusions

Methamphetamine use at 6 months (similar results at 3, 9 and 12 months)No.

[no. of participants]

272

[442]
No.

[no. of participants]

267

[440]
RR 1.01 (0.91 to 1.13)0.79Randomised peer education, social network intervention and control (social skills training) are both associated with reductions in methamphetamine use and increases in condom use over 12 months among a sample of young Thai people

Recovery of depressive symptoms at 12 months (index patient) measured using CES-D scoreMean (SD)

[no. of participants]

15.7 (9.7)

[209]
Mean (SD)

[no. of participants]

17.9 (9.3)

[206]
MD -2.20 (-4.03 to -0.37)-The effect was strongly observed amount intervention index participants compared with both control and network participants

Recovery of depressive symptoms at 12 months (index and network patient combined) measured using CES-D score[no. of participants]

[495]
[no. of participants]

[488]
MD -1.05 [-3.20 to 1.11]-Contrary to expectation, mea and in CES-D score change did not substantially differ between intervention network participants and control network participants. Thus, there is no evidence that the differential intervention effect on depression diffuses to network members

Prevalence of depression at 12 months (index patient) measured using CES-D scoreEvents (No.)

[no. of participants]

57

[209]
Events (No.)

[no. of participants]

70

[206]
RR 0.80 (0.60 to 1.07)--

Prevalence of depression at 12 months (index and network patient combined) measured using CES-D score[no. of participants]

[495]
[no. of participants]

[488]
RR 0.88 (0.73 to 1.06)--

Hirani 2010 CRCT Pakistan(adults with depression, economic skills building intervention arm)NSHW-led economics skill building

n = 9
Usual care

n = 8
SMD (95% CI)-Comment: these are presented as SMDs (calculated in RevMan, to compare with other SMDs in comparison 1.6 and 1.7)

Severity of depressive symptoms measured using Becks Depression Inventory IIMean (SD)

20.1 (11.3)
Mean (SD)

27.63 (9.1)
SMD -0.69 (-1.73 to 0.35)-This study documents improved self efficacy and employment for women enrolled in economic skill-building compared with general counselling and to control.

Functional impairment measured using the General Self-Efficacy scale28.7 (6.2)21.63 (3.8)SMD -1.29 (-2.41 to -0.16)--

 CES-D: Center for Epidemiological Studies Depression scale; CID-S: Composite International Diagnostic-Screener; CI: confidence interval; LHW: lay health workers; MD: mean difference; No.: number; OPHR: other professionals with health roles; RR: risk ratio; SD: standard deviation; SMD: standardised mean difference.
 
Table 4. SoF 1: NSHW-led psychological interventions compared with usual care in treating common mental disorders in adults in low- and middle-income countries (RCTs)

What are the effects of NSHW-led psychological interventions for treating common mental disorders in adults in low- and middle- income countries? (additional outcomes to comparison 1)

Patient or population: Adults with common mental disorders (depression or anxiety, or both)
Settings: Low- and middle-income countries (China, Jamaica, Pakistan, Taiwan, Uganda)
Intervention: NSHWs conducting psychological interventions
Comparison: Usual care

OutcomesIllustrative comparative risks* (95% CI)Effect estimate
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual care NSHWs

Severity of CMD symptoms - all interventions

short term (0-6 months)
measured using various depression rating scales1
-The mean severity of CMD symptoms - NSHW interventions short term was
0.75 standard deviations lower
(1.29 to 0.21 lower)
SMD -0.75 (-1.29 to -0.21)1470
(6 studies)
⊕⊝⊝⊝
very low 2,3,4
-

Severity of CMD symptoms - all interventions

medium term (12 months)
measured using various CMD rating scales5
-The mean severity of CMD symptoms - NSHW interventions medium term was
0.47 standard deviations lower
(0.60 to 0.34 lower)
SMD -0.47 (-0.60 to -0.34)923

(2 studies)
⊕⊕⊕⊝
moderate 6,7
-

Functional impairment/disability in adults with CMD - NSHW interventions

short term (2-6 months)
measured using various functional impairment scales8
-The mean functional impairment of adults with CMD - NSHW interventions short term was
0.33 standard deviations lower

(0.80 lower to 0.13 higher)
SMD -0.33 (-0.80 to 0.13)1243
(4 studies)
⊕⊝⊝⊝
very low 9,10,11
-

Functional impairment/disability in depression/CMD (adults) - NSHW interventions

medium term (2-6 months)
measured using the Global Assessment of Functioning scale
-The mean functional impairment of adults with CMD - NSHW interventions medium term was
0.56 standard deviations lower
(0.70 to 0.42 lower)
SMD -0.56 (-0.70 to -0.42)798
(1 study)
⊕⊕⊕⊝
moderate12
-

*The basis for the assumed risk is the mean control group risk across studies for pooled results and the control group risk for single studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CMD: common mental disorders; CI: confidence interval; NSHW: non-specialist health worker; SMD: standardised mean difference.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Chen 2000 RCT Taiwan, Hirani 2010 CRCT Pakistan and Tiwari 2010 RCT China used the Beck's Depression Inventory; Rahman 2008 CRCT Pakistan used the Hamilton Depression Rating Scale; Ali 2003 RCT Pakistan used the AKUADS; Bolton 2003 C-RCT Uganda used the Hopkins Symptom Checklist (HSCL).
2 Serious study limitations: Two of the six trials in this analysis were judged at high risk of bias and one was unclear about possible risk of bias. Chen 2000 RCT Taiwan had unclear sequence generation and allocation concealment, all were self reported outcomes, there was possible contamination and there was a high dropout rate after randomisation, with no analysis of dropout versus non-dropout differences; Hirani 2010 CRCT Pakistan was unclear regarding allocation concealment, there was no blinding of outcome assessment (self reported outcomes), it was unclear if baseline measures and characteristics were similar in both groups; and the report provided no information on dropouts. Bolton 2003 C-RCT Uganda was not clear about allocation concealment and quasi randomisation of individuals within clusters (though randomisation of clusters) may have introduced bias. The three trials contributed 45% of the weight in the pooled analysis. Downgraded by 1.
3Serious inconsistency: I2 statistic = 94%. However, the inconsistency related to the magnitude of benefit favouring NSHW interventions rather than in the direction of effect. Downgraded by 1.
4 Serious imprecision: The 95% CI for the pooled estimates indicates appreciable benefit and non-appreciable benefit for collaborative care (appreciable SMD = ≥ 0.5; non-appreciable benefit ≤ 0.2). Downgraded by 1.
5 Baker-H 2005 CRCT Jamaica used the CED-S; Rahman 2008 CRCT Pakistan used the Hamilton Depression Rating Scale.
6 No serious study limitations: The CES-D used in Baker-H 2005 CRCT Jamaica is not validated in the Jamaican population and is not a measure of clinical depression but just identifies depressive symptoms. Most women were not likely to have been depressed. Also in this study, there were unadjusted differences in baseline characteristics. However, this study contributed only 14% weight to the pooled results and removal of this study did not alter the direction or precision of the effect estimate. Not downgraded.
7 Serious indirectness: The two trials included were the only two of the six trials that compared this intervention that had data over the medium term, and only one used a validated outcome measure. Downgraded by 1.
8 Bolton 2003 C-RCT Uganda used a sex-specific Functional Impairment Questionnaire; Rahman 2008 CRCT Pakistan used the Global Assessment of Functioning (GAF) scale, Hirani 2010 CRCT Pakistan used the General Self-efficacy Scale; Tiwari 2010 RCT China used the Short Form- 12 (SF-12) (mental and physical components).
9 Serious study limitations: Two of the four studies were at risk of bias. Bolton 2003 C-RCT Uganda was not clear about allocation concealment and quasi-randomisation of individuals within clusters (though randomisation of clusters) may have introduced bias. Hirani 2010 CRCT Pakistan was unclear regarding allocation concealment, there was no blinding of outcome assessment (self reported outcomes), it was unclear if baseline measures and characteristics were similar in both groups; and the report provided no information on dropouts. Downgraded by 1.
10 Very serious inconsistency: I2 statistic = 90%. The inconsistency related to the direction of effect between interventions and was unexplained. Downgraded by 2.
11 Serious imprecision: the 95% CI of the pooled estimate showed appreciable benefit for interventions (appreciable SMD = 0.5) and non-appreciable benefit for control. Downgraded by 1.
12 Serious imprecision: the 95% CI of the pooled estimate shows non-appreciable benefit for psychological interventions and usual care (appreciable SMD = 0.5). However, the data for this outcome were from only one trial. Downgraded by 1.
 
Table 5. SoF: NSHW-led interventions compared with usual care in treating common mental disorders in adults in low- and middle-income countries (CBAs)

What are the effects of NSHWs conducting single interventions compared with usual care in treating common mental disorders for mental health care in low- and middle-income countries? (additional CBA outcomes to comparison 1)

Patient or population: Adults with CMDs (such as depression and anxiety)
Settings: Low- and middle-income countries (Indonesia, Rwanda)
Intervention: NSHWs conducting single interventions
Comparison: Usual care

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual care NSHWs

Severity of common mental disorders - short term (within 6 months)
measured using CMD rating scales1
-The mean severity of CMDs - short term (within 6 months post intervention) in the intervention groups was
0.08 standard deviations lower
(0.25 lower to 0.09 higher)
SMD -0.08 (-0.25 to 0.09)533
(2 studies)
⊕⊝⊝⊝
very low2,3
-

Severity of CMDs - medium term (8 months)
measured using SRQ-20
-The mean severity of CMDs - medium term (6 months to 1 year post intervention) in the intervention groups was
0.32 standard deviations lower
(0.6 to 0.04 lower)
SMD -0.32

(-0.6 to -0.04)
200
(1 study)
⊕⊝⊝⊝
very low4,5
-

Functional impairment - male short term (1 month)
measured using WHODAS (adapted) 11 items
-The mean functional impairment - male short term (within 6 months of intervention) in the intervention groups was
0.32 standard deviations lower
(0.65 lower to 0.02 higher)
SMD -0.32 (-0.65 to 0.02)141
(1 study)
⊕⊝⊝⊝
very low6,7
-

Functional impairment - female short term (1 month)
measured using WHODAS (adapted) 11 items
-The mean functional impairment - female short term (within 6 months of intervention) in the intervention groups was
0.34 standard deviations lower
(0.63 to 0.06 lower)
SMD -0.34 (-0.63 to -0.06)192
(1 study)
⊕⊝⊝⊝
very low6
-

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; CMD: common mental disorders; NSHW: non-specialist health worker; SMD: standardised mean difference; SRQ: Self Reporting Questionnaire; WHODAS: World Health Organization Disability Assessment Scale.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Bass 2012 CBA Indonesia: Hopkins Symptom Checklist 25; Scholte 2011 CBA Rwanda: SRQ-20.
2 Very serious risk of bias: Bass 2012 CBA Indonesia: controlled before-and-after study so non-random and not concealed. Also differences in baseline outcomes for girls, and doubt about reliability of primary outcomes as tool not properly validated. Scholte 2011 CBA Rwanda: controlled before-and-after study so non-randomised and no concealment. Also unclear risk for incomplete outcome data, there are baseline differences in outcomes and in characteristics not all adjusted for, and high rate of loss to follow-up with no analysis of group lost to follow-up. Downgraded by 2.
3 No imprecision: Non-appreciable benefit for either intervention or control group.
4 No explanation was provided.
5 No imprecision: Appreciable and non-appreciable benefit for intervention.
6 Very serious risk of bias: Bass 2012 CBA Indonesia: controlled before-and-after study so non-random and not concealed. Also differences in baseline outcomes for girls, and doubt about reliability of primary outcomes as tool not properly validated. Downgraded by 2.
7 Serious imprecision: Appreciable benefit for intervention and non-appreciable benefit for usual care. Downgrade by 1.
 
Table 6. SoF 2: Collaborative care model (NSHWs plus specialist) compared with usual care in treating common mental disorders in adults in low- and middle-income countries (RCTs)

What are the effects of a collaborative care model (NSHW plus specialist supervision) for mental health care in adults with common mental disorders low- and middle-income countries? (additional outcomes to comparison 2)

Patient or population: Adults (≥ 18 years) with common mental disorders (includes anxiety or depression, or both)
Settings: Middle-income countries (Chile, India)
Intervention: Collaborative care model (NSHW plus specialist supervision)

Comparison: Enhanced usual care

OutcomesIllustrative comparative risks* (95% CI)Effect estimate
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

usual careCollaborative care model

Prevalence of CMDs medium term (12 months)
measured using CIS-R generated ICD-10 diagnosis for CMD
See commentSee commentRR 0.95
(0.68 to 1.33)
2009
(1 study)
⊕⊕⊝⊝
low1
Patel 2010 C-RCT India did not reveal significant differences in the prevalence of depression with both interventions in public or private care facilities.

Severity of symptoms in CMD

short term (2-6 months)
measured using various rating scales2
-The mean severity of symptoms in CMD with collaborative care was
0.31 standard deviations lower
(0.56 to 0.06 lower)
SMD -0.31 (-0.56 to -0.06)3604
(5 studies)
⊕⊝⊝⊝
very low3,4,5
-

Severity of symptoms in CMD

medium term (12 months)
measured using CIS-R rating scale
-The mean severity of symptoms in CMD with collaborative care was
0.03 standard deviations lower
(0.12 lower to 0.06 higher)
SMD -0.03 (-0.12 to 0.06)1905
(1 study)
⊕⊕⊕⊝
moderate6
-

Functional impairment/disability in CMD short term (2-6 months)
measured using various functional disability scores7
-The mean functional impairment/disability in CMD with collaborative care was
0.22 standard deviations lower
(0.44 to 0.01 lower)
SMD -0.22 (-0.44 to -0.01)3604
(5 studies)
⊕⊝⊝⊝
very low5,8,9
-

Functional impairment/disability in CMD medium term (12 months)
measured using WHODAS II scores
-The mean functional impairment/disability in CMD with collaborative care was
0.02 standard deviations lower
(0.11 lower to 0.07 higher)
SMD -0.02 (-0.11 to 0.07)1905

(1 study)
⊕⊕⊕⊝
moderate6
-

*The basis for the assumed risk is the mean control group risk across studies for pooled results and the control group risk for single studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; CIS-D: Composite International Diagnostic-Screener; CMD: common mental disorders; ICD: International Classification of Diseases; NSHW: non-specialist health worker; RR: risk ratio; SMD: standardised mean difference; WHODAS: World Health Organization Disability Assessment Scale.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Very serious imprecision: The 95% CI for the pooled estimates indicates appreciable benefit for collaborative care and appreciable benefit for usual care. Downgraded by 2.
2 Jenkins 2012 C-RCT Kenya used the General Health Questionnaire (GHQ)-12. Patel 2010 C-RCT India used CIS-R to generate ICD-10 depression diagnoses; Fritsch 2007 RCT Chile and Araya 2003 RCT Chile used the Hamilton Depression Rating Scale (HDRS); Rojas 2007 RCT Chile used the: Edinburgh Postnatal Depression Scale (EPDS).
3 Serious study limitations: In Araya 2003 RCT Chile and possibly in Fritsch 2007 RCT Chile general practitioners (GPs) did both interventions, so there was a high risk of contamination; this would have reduced the potential benefits with collaborative care in two of the four trials in the meta-analysis. Downgraded by 1.
4 Serious inconsistency. The I2 statistic = 91% with Araya 2003 RCT Chile clearly an outlier, contributing to this unexplained inconsistency. However, the inconsistency related to the magnitude of benefit favouring collaborative care rather than in the direction of effect. Downgraded by 1.
5 Serious indirectness: Jenkins 2012 C-RCT Kenya used the GHQ-12 to grade severity of symptoms; the GHQ is a screening instrument that is validated to screen for CMDs; its use to rate the severity of depression is less reliable). Downgraded by 1.
6 Serious imprecision: The 95% CI for the pooled estimates indicates no appreciable benefit for collaborative care (< 0.2) and non-appreciable benefit for usual care. The data come from one study (Patel 2010 C-RCT India), and therefore imprecise. Downgraded by 1.
7 Jenkins 2012 C-RCT Kenya used WHODAS II long version (36 items); Patel 2010 C-RCT India used the WHODAS II short version (12 items); Araya 2003 RCT Chile; Fritsch 2007 RCT Chile; and Rojas 2007 RCT Chile used SF-36 social functioning component.
8 Serious study limitations: In Araya 2003 RCT Chile and probably Fritsch 2007 RCT Chile, GPs did both intervention and control interventions so there was a high risk of contamination. Downgraded by 1.
9 Serious inconsistency. The I2 statistic = 87% with Araya 2003 RCT Chile clearly an outlier, contributing to this unexplained inconsistency. However, the inconsistency related to the magnitude of benefit favouring collaborative care rather than in the direction of effect. Downgraded by 1.
 
Table 7. SoF 3: NSHWs compared with usual care for treating maternal depression (RCTs)

What are the effects of NSHW-led interventions for treating maternal depression in low- and middle-income countries? (additional outcomes for comparison 3)

Patient or population: Adult women with maternal depression
Settings: Low- and middle-income countries (Chile, Jamaica, Pakistan, Taiwan)
Intervention: NSHW-led interventions
Comparison: Usual care

OutcomesIllustrative comparative risks* (95% CI)Estimate effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Usual careNSHWs

Severity of symptoms of perinatal depression - NSHW led-psychological interventions

short term (0-2 months)
measured using depression rating scales1
-The mean severity of symptoms of perinatal depression - short term with NSHW-led interventions was
0.5 standard deviations lower
(0.63 to 0.36 lower)
SMD -0.5 (-0.63 to -0.36)858
(2 studies)
⊕⊕⊕⊕
high2,3
Note that a small clinically appreciable benefit was set at SMD < 0.2, and a moderate benefit at SMD of 0.5 to 0.8 (Cohen 1988)

Severity of symptoms of perinatal depression - NSHW led-psychological interventions

medium term (12 months)
measured using a depression scale