Psychological therapies for the treatment of anxiety disorders in chronic obstructive pulmonary disease

  • Protocol
  • Intervention

Authors

  • Zafar A Usmani,

    Corresponding author
    1. The Queen Elizabeth Hospital, Department of Respiratory Medicine, Adelaide, Australia
    2. The Queen Elizabeth Hospital, Department of Medicine, University of Adelaide, Adelaide, Australia
    • Zafar A Usmani, Department of Respiratory Medicine, The Queen Elizabeth Hospital, 4A, Main Building, 28 Woodville Road, Woodville South, Adelaide, SA 5011, Australia. zafar-ahmad.usmani@health.sa.gov.au.

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  • Kristin V Carson,

    1. The Queen Elizabeth Hospital, Department of Medicine, University of Adelaide, Adelaide, Australia
    2. The Queen Elizabeth Hospital, Clinical Practice Unit, Adelaide, South Australia, Australia
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  • Karen Heslop,

    1. Newcastle upon Tyne NHS Hospitals Foundation Trust, Chest Clinic, Newcastle upon Tyne, Tyne & Wear, UK
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  • Adrian J Esterman,

    1. University of South Australia, Division of Health Sciences, Adelaide, Australia
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  • Anthony De Soyza,

    1. Newcastle University, Institute of Cellular Medicine, Newcastle, UK
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  • Brian J Smith

    1. The Queen Elizabeth Hospital, Department of Respiratory Medicine, Adelaide, Australia
    2. The Queen Elizabeth Hospital, Department of Medicine, University of Adelaide, Adelaide, Australia
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Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

To assess the effects of psychological therapies for the treatment of anxiety disorders in patients with chronic obstructive pulmonary disease.

Background

Description of the condition

Chronic obstructive pulmonary disease (COPD) consists primarily of chronic bronchitis and emphysema, conditions which are characterised by the inflammation of airways and the destruction of pulmonary tissues. The diagnosis of COPD is based on the documentation of a post bronchodilator forced expiratory volume1/forced vital capacity (FEV1/FVC) less than 70% (Rabe 2007). Anxiety disorder is a generalised term for a myriad of abnormal and pathological fear and anxiety states, including generalised anxiety disorder (GAD), panic disorder (PD), agoraphobia, neurocirculatory asthenia, obsessive-compulsive disorder (OCD), and phobic disorders.

Evidence suggests that there is an increased prevalence of anxiety disorders in patients with COPD (Maurer 2008). The lifetime prevalence of GAD in particular amongst patients with COPD is estimated at between 10% and 15.8% (Brenes 2003). GAD is defined as excessive anxiety which lasts for at least six months. Individuals must also experience three or more of the following symptoms: difficulty in concentrating; fatigue after little exertion; sleep disturbance; a sensation of being 'keyed up' (nervous or anxious); irritability or muscle tension, or both (Diagnostic and Statistical Manual (DSM) IV criteria) (APA 1994). Rates of anxiety symptoms in patients with COPD range from 13% to 51% and are higher than the rates in patients with heart failure, cancer, and other medical conditions (Brenes 2003).COPD is associated with a higher risk of anxiety, and once anxiety develops among patients with COPD it is related to poor health outcomes, including in terms of exercise tolerance, quality of life and COPD exacerbations (Eisner 2010). By compromising health status, mood disorders lead to increased risk of hospitalisation and re-hospitalisation (Gudmundsson 2005) and hence also increase direct and indirect costs to the health system.

Various models could be considered to explain increased levels of anxiety and panic in patients with COPD (Ley 1985; Perna 2004). One of the models (Clark 1986) explains this relationship as catastrophic misinterpretations of ambiguous bodily sensations (such as shortness of breath, rapid heart rate) which increase arousal, creating a positive feedback loop that results in a panic attack. A crucial difference between physically healthy people and those with COPD is that in the latter, breathing, the most basic of all physical functions necessary for life, is objectively threatened (as measured by tests of lung function) and subjectively difficult. Dyspnoea (shortness of breath) can be an unpleasant and potentially frightening experience at any time, and, as the key symptom of an eventually fatal illness like COPD, it is an ambiguous sensation open to catastrophic interpretation, leading to increased levels of anxiety and panic in people with COPD (Livermore 2010).

Description of the intervention

Management strategies for the treatment of anxiety disorders in people with COPD include both pharmacological and non-pharmacological interventions. Evidence that pharmacological therapies (anti-anxiety and/or antidepressant medications) provide statistically or clinically significant benefits for this group of patients is limited (Usmani 2011). Psychological therapies include cognitive and/or behavioural therapies, psychodynamic psychotherapy, interpersonal psychotherapy, non-directive therapy, support therapy and counselling (Rose 2002; Davison 2003). Psychological therapies are intentional interpersonal relationships used by trained psychotherapists to aid patients with problems of living, with an aim of increasing the individual's well-being. Psychological therapies may also be performed by practitioners with a number of different qualifications, including psychologists, marriage and family therapists, occupational therapists, licensed clinical social workers, counsellors, psychiatric nurses, psychoanalysts, and psychiatrists.The mode of delivery for these therapies comprise individual, group or family (including couple) therapy, performed by a healthcare professional.

How the intervention might work

Because COPD is an irreversible condition, treatment recommendations are aimed at improving quality of life (Norweg 2005). Current evidence examining quality of life suggests a reduction in satisfaction above and beyond what should be expected by COPD disease severity or co-morbid medical illnesses (Coventry 2007), indicating that psychological status plays an intrinsic role in overall well-being. A recent study examining the impact of anxiety on the lives of patients with COPD found that patients felt isolated and would avoid social occasions and usual daily activities (Willgoss 2011). As a result, therapies targeting the reduction of psychological stressors should be expected to improve quality of life (Ries 1995; Rose 2002; Baraniak 2011).

Psychological therapies are often based on the assumption that psychological outcomes such as anxiety are linked with physical manifestations of COPD, for example dyspnoea, which can precipitate episodes of anxiety (Wu 2004). It has been hypothesised that a patient's fear and misinterpretation of bodily experiences from dyspnoea and hyperventilation cause a panic reaction (Nutt 1999). Alternatively, underlying psychological distress can contribute to an increased risk of symptom exacerbations, particularly those treated in the patient's own environment (Laurin 2011). As such, patients with anxiety and panic disorders interpret threats as more dangerous due to a higher awareness of cues such as dyspnoea and tachycardia (Mikkelsen 2004).

A psychological therapy, cognitive-behaviour therapy (CBT), aims to identify and correct dysfunctional emotions, behaviours and cognitions through a goal-oriented, systematic procedure (Rose 2002; Kaplan 2009). In the case of COPD patients, CBT may be a means of managing concurrent anxiety and depression. While not in itself improving an individual's medical condition, CBT may serve to increase perceived self-efficacy and motivate patients to manage their physical condition, thereby improving quality of life (Kunik 2001). Moreover, the learning about oneself that occurs in various forms of psychological therapy may in itself influence the structure and function of brain (Kandel 1998) or may have a significant impact on serotonin metabolism (Viinamaki 1998). 'Third wave CBT' applies to behavioural psychological therapies that integrate mindfulness and acceptance of unwanted thoughts and feelings with a behavioural understanding of emotional suffering, to elicit change in thinking process. Behavioural therapy includes methods that focus on behaviours, not the thoughts and feelings that might be causing them. The behavioural approach to therapy assumes that behaviour that is associated with psychological problems develops through the same processes of learning that affect the development of other behaviours. Psychodynamic therapy focuses on unconscious processes as they are manifested in patients' present behaviour. Hence by making the unconscious aspects of their life a part of their present experience, psychodynamic therapy helps people understand how their behaviour and mood are affected by unconscious feelings. Humanistic psychotherapy emphasises human uniqueness, positive qualities, and individual potential. It works by emphasising one's capacity to make informed and rational choices and develop to one's maximum potential. Integrative therapies are approaches that combine components of different psychological therapy models.

Why it is important to do this review

Anxiety disorders in people with COPD have been shown to increase disability and impair functional status, resulting in an overall reduction in their quality of life (Beck 1988; Weaver 1997). Importantly, the impact of anxiety on these outcomes was shown after adjusting for other potential confounders such as general health status, other medical conditions and COPD severity (Brenes 2003). Kim 2000 reported that anxiety and depression were more strongly related to functional status than the severity of COPD. Co-morbid anxiety in an elderly population with COPD has been suggested as a significant predictor of the frequency of hospital admissions (Yohannes 2000). A recent study has shown that among patients with COPD, anxiety is related to poorer health outcomes including worse submaximal exercise performance, greater risk of self-reported functional limitations and a higher longitudinal risk of COPD exacerbations (Eisner 2010). However, the evidence for treatment of anxiety disorders in COPD is limited, and there are limited data to support the efficacy of medication-only treatments (Borson 1998). The results of a Cochrane review evaluating the effects of pharmacological interventions for anxiety in patients with COPD are inconclusive (Usmani 2011). A feasibility study of antidepressants in this population suggested poor acceptance of antidepressants for various reasons including side-effects and reluctance to take ‘yet another medication’ (Yohannes 2001). Furthermore the association between anxiety/panic and dyspnoea/COPD had been explained by various psychological theories (Clark 1986; Livermore 2010). It is important therefore, to evaluate psychological therapies for the alleviation of these symptoms in patients with COPD.

In light of the health burden caused by psychological disorders and the limited evidence supporting treatment options, this review is one of four linked Cochrane reviews that will assess the effects of pharmacological and psychological therapies for the treatment of anxiety and depression in patients with COPD, one of which has already been published (Usmani 2011) and two of which are in progress (Usmani 2013a, Usmani 2013b).

Objectives

To assess the effects of psychological therapies for the treatment of anxiety disorders in patients with chronic obstructive pulmonary disease.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs), including cross-over trials and cluster randomised trials.

Types of participants

Participants will be adults over 40 years of age (as it is very unlikely that people less than 40 years old have clinically-significant COPD (GOLD 2013)) of either sex and of any ethnicity, diagnosed with COPD and a recognised anxiety disorder or anxiety symptoms.

The COPD diagnosis needs to have been made by a medical professional clinically, or by GOLD (Global initiative for chronic Obstructive Lung Disease) criteria, or both (FEV1/FVC < 0.70).

The anxiety disorder (e.g. generalised anxiety disorder (GAD), panic disorder (PD), agoraphobia, neurocirculatory asthenia, obsessive-compulsive disorder (OCD), phobic disorders) needs be defined using established diagnostic criteria e.g. DSM criteria (APA 1994), and anxiety symptoms identified using a formal psychological instrument e.g. Beck Anxiety Inventory (BAI) (Beck 1961; BAI 1993) at the time of recruitment to the trial.

We will include participants with co-morbid mental health disorders. Anxiety need not be the primary mental health disorder for included participants as long as they had formally diagnosed or symptomatic anxiety (as diagnosed or assessed by a formal criteria or a validated tool).

We will exclude studies that only assess psychological therapies for the treatment of depression in patients with COPD, as these will be covered by a separate review.

Types of interventions

We will include studies assessing any form of psychological therapy for the treatment of anxiety disorders in people with COPD where this is compared with either no intervention or education only. We will include studies in which the psychological therapy is delivered in combination with another intervention (co-intervention) only if there is a comparison group that received the co-intervention alone.

Experimental interventions:

  • Cognitive behavioural therapy (CBT) (e.g. problem solving, rational emotive therapy)

  • Third Wave CBT (i.e. acceptance and commitment therapy, compassionate mind training, functional analytic psychotherapy, mindfulness-based cognitive therapy, behavioural activation, meta-cognitive therapy and dialectical behavioural therapy)

  • Behavioural therapy (e.g. behaviour modification, assertiveness training)

  • Psychodynamic therapy (e.g. insight-oriented therapy, group psychotherapy)

  • Humanistic therapy (e.g. expressive therapy, supportive therapy)

  • Integrative therapy (e.g. cognitive analytical therapy).

Comparators:

  • No intervention (i.e. waiting list and usual care)

  • Education only (education (written or oral), such as provision of information about physical and mental health issues during a medical consultation or during a visit with a nurse where no formal counselling or psychological therapy was provided)

  • Co-intervention (only if the same co-intervention was used in the intervention arm of the study). The co-interventions included will be pharmacotherapy and pulmonary rehabilitation.

Types of outcome measures

Primary outcomes

1. Change in anxiety symptoms as measured by a standardised or validated anxiety measure e.g. State-Trait Anxiety Inventory (STAI) (Spielberger 1970), the Hospital Anxiety and Depression Scale (HADS) (HADS 1983) and the Beck Anxiety Inventory(BAI) (Beck 1961; BAI 1993). These scales generate a total score which will be recorded for all pair-wise comparisons as short-term follow up data (up to and including six months) and/or long term follow-up data (greater than six months).
2. Adverse events

Secondary outcomes

Each of the secondary outcomes will be assessed based on a validated assessment scale. The secondary outcomes measured will include:

3. Change in quality of life e.g. the St George’s respiratory questionnaire (SGRQ) (Jones 1991). Generic, validated quality of life measures will also be included
4. Difference in exercise tolerance e.g. the six-minute walk test (Butland 1982)
5. Change in dyspnoea scores e.g. the Borg scale (Borg 1982)
6. Change in length of stay or readmission rate
7. Change in forced expiratory volume in one second (FEV1)

Timing of outcome assessment

Time frames will be defined as short-term (up to three months), medium-term (three to six months) and long-term follow up (more than six months).

Search methods for identification of studies

Electronic searches

Cochrane Specialised Registers
CCDAN Register (CCDANCTR)

The Cochrane Depression, Anxiety and Neurosis Group (CCDAN) maintain two clinical trials registers at their editorial base in Bristol, UK; a references register and a studies-based register. The CCDANCTR-References Register contains over 28,000 reports of randomised controlled trials in depression, anxiety and neurosis. Approximately 65% of these references have been tagged to individual, coded trials. The coded trials are held in the CCDANCTR-Studies Register and records are linked between the two registers through the use of unique Study ID tags. Coding of trials is based on the EU-Psi coding manual. Please contact the CCDAN Trials Search Coordinator for further details. Reports of trials for inclusion in the Group's registers are collated from routine (weekly), generic searches of MEDLINE (1950-), EMBASE (1974-) and PsycINFO (1967-); quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL) and review-specific searches of additional databases. Reports of trials are also sourced from national and international trials registers via the World Health Organisation’s trials portal (ICTRP), drug companies, the handsearching of key journals, conference proceedings and other (non-Cochrane) systematic reviews and meta-analyses. Details of CCDAN's generic search strategies can be found on the Group‘s website.

The CCDANCTR (Studies and References Registers) will be searched using the following terms:

(anxi* or *phobi* or PTSD or post-trauma* or posttrauma or “post trauma*” or "combat disorder" or panic or OCD or obsess* or compulsi* or GAD or stress* or distress* or neurosis or neuroses or neurotic or psychoneuro*)
AND
((obstruct* and (pulmonary or lung* or airway* or airflow* or bronch* or respirat*)) or COPD or emphysema or (chronic* and bronchiti*))

CARG Register

The Cochrane Airways Group's Specialised Register is also derived from systematic searches of bibliographic databases including: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, AMED, and PsycINFO, and handsearching of respiratory journals and meeting abstracts (please see the Airways Group Module for further details).

All records in the CARG Specialised Register coded as 'COPD' will be searched using terms for 'Anxiety Disorders' as listed above.

An additional search of CENTRAL and PsycINFO will be conducted to ensure no record has been missed from these databases in the creation of the CCDANCTR and CARG Specialised Registers (Appendix 1).

National and international trials registers

Complementary searches will be conducted on the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov.

Searching other resources

We will handsearch reference lists of retrieved, relevant articles to identify any other potentially-relevant articles. We will contact authors of potentially-included studies for raw data or unpublished data if required.

Data collection and analysis

Selection of studies

All citations generated from the search strategies will be independently assessed by two of three review authors (KC, ZU, KH) to determine whether they satisfy the Criteria for considering studies for this review, through screening of the title, abstract and descriptors. Studies identified as potentially relevant will have full text articles retrieved and examined for final inclusion by two of three independent authors as above. Disagreements will be resolved through discussion and by a third party if necessary (BS or AD).

Data extraction and management

The following data will be extracted using a standardised and piloted data extraction form by two independent review authors (a combination of ZU, KC and KH), for each included study. Any discrepancies will be resolved by discussion between the authors and if needed, a third party (BS or AD).

Study eligibility

Study design, population group and description of psychological therapy.

Participants

Number of participants, age, gender distribution, ethnicity and co-morbidities.

Interventions

Description of intervention, duration, intensity, who it was delivered by.

Main comparisons
  1. Psychological therapies versus no intervention.

  2. Psychological therapies versus education.

  3. Psychological therapies and co-intervention versus co-intervention alone.

These comparisons will be stratified according to psychological therapy, however, an overall pooled estimate for intervention effectiveness will not be performed for all psychological therapies in each of these comparisons, i.e. sub-totals only will be used in the analyses.

Assessment of risk of bias in included studies

The risk of bias for all the included studies will be assessed by two independent review authors using a domain-based evaluation. Risk of bias will be assessed as 'Low risk of bias', 'High risk of bias' and 'Unclear risk of bias' as per the guidelines in the Cochrane Handbook for Systematic Reviews of Interventions, table 8.5.c (Higgins 2011). Conflicts in the assessment will be resolved either by consensus or by referring to a third party. The domains evaluated will be:

Sequence generation

Methods considered adequate include: random number table, computer random number generator, coin toss, shuffling cards or envelopes, throwing dice and drawing lots (Higgins 2011).

Allocation concealment

Methods considered adequate include: central allocation (phone, web, pharmacy), sequentially-numbered identical drug containers and serially-numbered sealed and opaque envelopes (Higgins 2011).

Blinding (of participants)

Blinding will be considered adequate if: trial authors mention that participants were blinded to the intervention, although for psychological therapies this will be unlikely due to the difficulties associated with delivery of communication-based interventions (Higgins 2011).

Blinding (of outcome assessors)

Blinding will be considered adequate if: authors mention that outcome assessors were blinded to sequence allocation (Higgins 2011).

Incomplete outcome data

Risk of bias due to incomplete outcome data will be assessed on the grounds of whether the incomplete outcome data were adequately addressed or not, as per the Cochrane Handbook section 8.12 (Higgins 2011).

Selective outcome reporting

Studies will be considered to be at low risk of bias if a protocol is available and all pre-specified outcomes are reported in the pre-specified way, or in the absence of a protocol, if all expected outcomes are reported (and as per recommendations in table 8.5.c, Higgins 2011).

Other bias

Studies will be considered at a low risk of other bias if they were conducted in such a way as to ensure no other influencing factors that could potentially affect the outcome were evident. Examples of other biases include: extreme baseline imbalances for participants or outcomes, contamination of the intervention or control group, and selective recruitment of study participants.

The results of the 'Risk of bias' assessment will be presented in a 'Risk of bias' table and described narratively within the results of the review.

Measures of treatment effect

Continuous data

Available data will be summarised by either mean differences (MD) or standardised mean differences (SMD) where appropriate, using mean values and standard deviations. We will consult a statistician for additional support if required (AE).

Dichotomous data

For dichotomous data we will calculate odds ratios with 95% confidence intervals. Data will be presented as either final values (post-intervention) or as change from baseline if raw data from the trialists cannot be retrieved.

Unit of analysis issues

Cluster-randomised trials

Cluster randomised controlled trials, i.e. trials in which outcomes relate to individual subjects whilst allocation to the intervention is by hospital, clinic or practitioner, may introduce unit of analysis errors. Using statistical methods which assume for example that all patients’ chances of benefit are independent, ignores the possible similarity between outcomes for patients seen by the same provider. This may underestimate standard errors and give misleadingly narrow confidence intervals, leading to the possibility of a type 1 error (Altman 1997). For cluster randomised studies, analysis will be performed at the level of individuals whilst accounting for the clustering in the data using a random-effects model for pooled meta-analysis as recommended in the Cochrane Handbook (chapter 16.3.3) (Higgins 2011) and checked by a statistician (AE). For those studies which do not adjust for clustering, the actual sample size will be replaced with the effective sample size (ESS), calculated using a rho = 0.02 as per Campbell 2000.

Cross-over trials

Data from cross-over studies will be extracted for the first phase only (pre-cross-over), due to the potential for a significant carry-over effect for psychological therapies.

Studies with multiple treatment groups

Multi-arm trials will be included provided there is an intervention arm with any of the interventions mentioned in the experimental group above and a control arm with any of comparators mentioned above. In the case of multi-arm trials we will include each pair-wise comparison separately, but with shared intervention groups divided out approximately evenly among the comparators. However, if the intervention groups are deemed similar enough to be pooled, the groups will be combined using appropriate formulae in the Cochrane Handbook (table 7.7.a for continuous data and chapter 16.5.4 for dichotomous data, (Higgins 2011)).

Dealing with missing data

We will evaluate missing information regarding participants on an available case-analysis basis as described in chapter 16.2.2 of the Cochrane Handbook (Higgins 2011). Where statistics essential for analysis are missing (e.g. group means and standard deviations (SDs) for both groups not reported) and cannot be calculated from other data, we will attempt to contact the study authors to obtain the data. We will consider that any loss of participants that would occur before the baseline measurements are performed would not affect the eventual outcome data of the study. Any losses after the baseline measurements are taken may affect trial validity. For drop outs at the initial phase of a trial (by the end of the second week of intervention/placebo administration), we will not include their data and for these studies we will use the final data from the completers only. For participants who drop out after the second week or with unclear drop out time, we will use the last observation carried forward (LOCF), providing we can obtain raw data. If we are unsuccessful, we will report the missing data under 'other' sources of bias in the 'Risk of bias' tables and discuss the details in the text.

Assessment of heterogeneity

We expect this review to have some heterogeneity, contributed by factors such as baseline severity of anxiety, severity of underlying COPD, time of measurement of results and varying measuring tools used to assess outcomes. The Chi² and I² statistics (Higgins 2011) will be used to quantify inconsistency across studies in combination with visual inspection of the data for differences between studies (e.g. types of interventions, participants etc.) Thresholds for the interpretation of the I² statistic can be misleading, since the importance of inconsistency depends on several factors (Higgins 2011). These include magnitude and direction of the effect and strength of the evidence for heterogeneity, for example the P value from the Chi² test, or a confidence interval for I². For the purpose of this review, we will consider an I² statistic representing substantial or considerable heterogeneity for further investigation through subgroup analyses to examine possible causes, as per chapter 9.5.2 of the Cochrane Handbook (Higgins 2011). The overlapping bands for the I² statistic are:

  • 0% to 40%: might not be important;

  • 30% to 60%: may represent moderate heterogeneity;

  • 50% to 90%: may represent substantial heterogeneity;

  • 75% to 100%: considerable heterogeneity.

Assessment of reporting biases

Providing there are more than ten included studies, we will assess potential reporting biases using a funnel plot. Asymmetry in the plot might be attributed to publication bias, but may well be due to true heterogeneity or a poor methodological design. In case of asymmetry, contour lines may be included corresponding to perceived milestones of statistical significance (P = 0.01, 0.05, 0.1 etc.) to funnel plots, which may help to differentiate between asymmetry due to publication bias from that due to other factors (Higgins 2011). No additional formal testing for funnel plot asymmetry will be performed. If there are fewer than ten studies, the reporting biases will be extrapolated within the ’other bias’ section in the 'Risk of bias' tables.

Data synthesis

The extracted data will be pooled in meta-analyses using the random-effects model to allow for expected heterogeneity (due to expected differences in the interventions and populations). All included studies will be assessed for inclusion in the primary analyses, and a sensitivity analysis will be performed for studies which are at an unclear or high risk of bias for sequence generation and allocation concealment, and for studies involving participants who have significant co-morbidities e.g. dementia or severe heart failure. We will perform separate meta-analyses for intervention subgroups as defined under Subgroup analysis and investigation of heterogeneity. For trials reporting data at more than one point in time, we will extract data from the final follow-up period reported by trialists. Data will be analysed using Review Manager (RevMan) 5.2 software (RevMan 2012).

Subgroup analysis and investigation of heterogeneity

We expect that the included studies will be heterogeneous due to multiple factors including baseline severity of anxiety, severity of underlying COPD, duration of intervention and multiple measuring tools assessing the same outcome. As such, we have pre-specified subgroups to investigate this heterogeneity to reduce the likelihood of spurious findings, first by limiting the number of subgroups investigated and second by preventing knowledge of the studies’ results influencing which subgroups are analysed (Higgins 2011). These contributing factors were identified as relevant in our previous completed review for pharmacological interventions for anxiety in COPD (Usmani 2011). We will describe all included studies in table and narrative form reporting on study design, population, intervention characteristics and outcome measures.

We will perform subgroup analyses for the above-mentioned psychological therapies according to:

  1. duration of intervention (e.g. 0 to 3 months, 3 to 6 months, > 6 months); and

  2. severity of anxiety symptoms (i.e. mild, moderate and severe).

These subgroups will permit an examination into the possible causes of heterogeneity, however their primary objective is to extrapolate data for the purposes of forming hypotheses.

Sensitivity analysis

We will conduct sensitivity analysis to examine the effects of methodological decisions taken throughout the review process, particularly in regard to the inclusion criteria. We will test the validity and robustness of the findings by removing studies based on the following criteria:

  1. Inadequate sequence generation;

  2. Inadequate allocation concealment;

  3. Significant attrition of the study population (20% or higher attrition);

  4. Studies on populations with significant co-morbidities;

  5. Cluster randomised trials;

  6. Cross-over studies;

  7. Studies containing data imputed by the review authors.

Acknowledgements

We acknowledge the assistance of the editors and staff of the Cochrane Depression, Anxiety and Neurosis Review Group.

CRG Funding Acknowledgement:
The National Institute for Health Research (NIHR) is the largest single funder of the Cochrane Depression, Anxiety and Neurosis Group. 

Disclaimer:
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health.

Appendices

Appendix 1. Additional Search Strategies (CENTRAL and PsycINFO):

CENTRAL search strategy:

#1. MeSH descriptor LUNG DISEASES, OBSTRUCTIVE, this term only
#2. MeSH descriptor PULMONARY DISEASE, CHRONIC OBSTRUCTIVE explode all trees
#3. emphysema*
#4. chronic* near/3 bronchiti*
#5. (obstruct*) near/3 (pulmonary or lung* or airway* or airflow* or bronch* or respirat*)
#6. COPD
#7. COAD
#8. COBD
#9. AECB
#10. (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9)
#11. MeSH descriptor ANXIETY, this term only
#12. MeSH descriptor ANXIETY DISORDERS explode all trees
#13. MeSH descriptor ANXIETY, SEPARATION, this term only
#14. MeSH descriptor PANIC, this term only
#15. MeSH descriptor OBSESSIVE BEHAVIOR explode all trees
#16. MeSH descriptor COMPULSIVE BEHAVIOR explode all trees
#17. MeSH descriptor STRESS, PSYCHOLOGICAL explode all trees
#18. MeSH descriptor NEUROTIC DISORDERS, this term only
#19. (anxiety or phobi* or agoraphobi* or claustrophobi* or PTSD or post-trauma* or posttrauma or (post NEXT trauma*) or (combat NEXT disorder) or panic or OCD or obsess* or compulsi* or GAD or stress* or distress* or neurosis or neuroses or neurotic or psychoneuro*)
#20. (#11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19)
#21. (#10 and #20)

OVID PsycINFO search strategy:

  1. Lung Disorders/

  2. Pulmonary Emphysema/

  3. (chronic* adj3 bronchiti*).mp.

  4. emphysema*.mp.

  5. (obstruct* adj3 (pulmonary or lung* or airway* or airflow* or bronch* or respirat*)).mp.

  6. COPD.mp.

  7. COAD.mp.

  8. COBD.mp.

  9. AECB.mp.

  10. or/1-9

  11. exp Anxiety/

  12. exp Anxiety Disorders/

  13. exp Phobias/

  14. exp Neurosis/

  15. exp Stress/

  16. exp Trauma/

  17. Emotional Trauma/

  18. Panic Attack/ or Panic/ or Panic Disorder/

  19. (anxiety or phobi* or agoraphobi* or claustrophobi* or PTSD or post-trauma* or posttrauma or post trauma* or combat disorder or panic or OCD or obsess* or compulsi* or GAD or stress* or distress* or neurosis or neuroses or neurotic or psychoneuro*).mp.

  20. or/11-19

  21. treatment effectiveness evaluation.sh.

  22. clinical trials.sh.

  23. mental health program evaluation.sh.

  24. placebo.sh.

  25. placebo*.ti,ab.

  26. randomly.ab.

  27. randomi#ed.ti,ab.

  28. trial*.ti,ab.

  29. ((singl* or doubl* or trebl* or tripl*) adj3 (blind* or mask* or dummy)).mp.

  30. (control* adj3 (trial* or study or studies or group*)).ti,ab.

  31. "2000".md.

  32. factorial*.ti,ab.

  33. allocat*.ti,ab.

  34. assign*.ti,ab.

  35. volunteer*.ti,ab.

  36. (crossover$ or cross over*).ti,ab.

  37. (quasi adj (experimental or random*)).mp.

  38. or/21-37

  39. (10 and 20 and 38

Contributions of authors

Protocol prepared by Zafar A Usmani, Kristin V Carson and Karen Heslop with feedback provided by Adrian J Easterman, Anthony De Soyza and Brian J Smith.

Declarations of interest

Dr De Soyza has received no fees nor grants that relate to anxiety and depression management in COPD. He has received fees for speaker meetings or consultancy work on management of COPD airways disease management from a variety of commercial companies. He has also received financial support from multiple partners in th past to attend national congresses/ symposia and has also had cofunding offers towards a multicentre bronchiectasis grant.

Karen Heslop  has received fees for speaker meetings or consultancy work on management of COPD airways disease management from a variety of commercial companies and has received a NIHR Fellowship grant to undertake a RCT of CBT in COPD.

All other authors: None known.

Sources of support

Internal sources

  • Respiratory Department - The Queen Elizabeth Hospital, Australia.

External sources

  • No sources of support supplied

Ancillary