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Cognitive behavioural therapies for fibromyalgia

  1. Kathrin Bernardy1,
  2. Petra Klose2,
  3. Angela J Busch3,
  4. Ernest HS Choy4,
  5. Winfried Häuser5,*

Editorial Group: Cochrane Pain, Palliative and Supportive Care Group

Published Online: 10 SEP 2013

Assessed as up-to-date: 4 SEP 2013

DOI: 10.1002/14651858.CD009796.pub2


How to Cite

Bernardy K, Klose P, Busch AJ, Choy EHS, Häuser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD009796. DOI: 10.1002/14651858.CD009796.pub2.

Author Information

  1. 1

    BG University Hospital Bergmannsheil GmbH, Ruhr University Bochum, Department of Pain Medicine, Bochum, Germany

  2. 2

    University of Duisburg-Essen, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, Essen, Germany

  3. 3

    University of Saskatchewan, School of Physical Therapy, Saskatoon, SK, Canada

  4. 4

    Cardiff University School of Medicine, Section of Rheumatology, Division of Infection and Immunity, Cardiff, UK

  5. 5

    Technische Universität München, Department of Psychosomatic Medicine and Psychotherapy, München, Germany

*Winfried Häuser, Department of Psychosomatic Medicine and Psychotherapy, Technische Universität München, Langerstr. 3, München, D-81675, Germany. whaeuser@klinikum-saarbruecken.de.

Publication History

  1. Publication Status: Stable (no update expected for reasons given in 'What's new')
  2. Published Online: 10 SEP 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]

MethodsStudy setting: Europe (Spain). Multicentre, primary healthcare centres, outpatient based. Patients were recruited from any of the 41 primary healthcare centres in the city of Zaragoza

Study design: Parallel

Duration therapy: 10-12 weeks

Follow-up: 6 months

Analysis: ANOVA for comparisons between groups (baseline), intention-to-treat approach, ANCOVA (covariate: baseline scores) to examine differences among outcomes of the groups post-treatment and follow-up, effect sizes (Cohen’s d)


ParticipantsPatients: Treatment Group: 57 patients, 95% female, 100% European, mean age 46 years: mean years since diagnosis:12.9 (7.1)

Control Group: 56 patients, 96% female, 100% European, mean age 47 years; mean years since diagnosis: 11.7 (4.0)

Inclusion: ACR 1990 criteria for FM, age 18 to 65 years, able to understand and read Spanish, no psychological treatment during the preceding two years, no pharmacological treatment at that time or willing to discontinue it for two weeks before start of the study

Exclusion: Axis I psychiatric disorders (dementia, schizophrenia, paranoid disorder, alcohol and/or drug abuse), axis II psychiatric disorders or other medical disorders that prevented patient from following the treatment protocol, women that were pregnant or nursing


InterventionsTreatment Group: CBT group: Cognitive restructuring, cognitive and behavioural coping strategies (1.5h/week), total: 15 h

Control Group: Treatment as usual (TAU): General practitioners received a guide for the treatment of fibromyalgia in primary care and selected a pharmacological treatment as well as the frequency of patient visits that they considered adequate

Co-medication allowed: Occasionally minor analgesics, no pregabalin, gabapentin, opioids, antidepressants permitted

Other co-therapies: None


OutcomesPrimary Outcomes

Self reported pain: Visual Analogue Scale pain (VAS pain) 0-100

Self reported negative mood: Hamilton Rating Scale for Depression (HAM-D) 0-50

Self reported disability: FIQ physical disability 0-10; data provided on request

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Pain Catastrophizing Scale (PCS) Helplessness 0-24

Self reported fatigue: FIQ (VAS) 0-10; data provided on request

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: Fibromyalgia Impact Questionnaire (FIQ) total 0-100


Notes1. Study arm recommended pharmacological therapy (pregabalin 300-600 mg/d or duloxetine 60-120 mg/d) not used for comparison

2. Reasons for dropout:

- Treatment Group: 1x lack of efficacy, 4x patient decision, 3x lost to follow-up

- Control group: 1x did not receive allocated intervention because person moved to another city, 2x adverse events, 3x lack of efficacy, 2x patient decision, 2 loss to follow-up

3. Attendance rates: Not reported

4: Responder analysis: None

5. Funding sources and declaration of interest of the primary researchers: The study was funded by a grant from the Carlos III Health Institute of the Spanish Ministry of Health and Consumption (ETES PI07/90959).The authors declared that they have no competing interests


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated random sequence

Allocation concealment (selection bias)Low riskAllocation sequence generated by a member of research group not involved in study

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis by last observation carried forward method

Selective reporting (reporting bias)Low riskAll outcomes reported

Blinding of outcome assessorLow riskStudy personnel who conducted psychological assessments were blinded to participants' treatment conditions


MethodsStudy setting: North America (USA). Details not reported, Outpatient based

Study design: Parallel

Duration therapy: 6 weeks

Follow-up: 12 weeks

Analysis: T-test, Chi2 tests, Fisher’s exact test to compare baseline characteristics and FIQ scores at week 12, mixed-effects linear model approach to compare treatment groups (with random subject effect and fixed effects for treatment group, visit (week 6 or 12), treatment group-visit interaction, baseline NFR threshold, study entry medications


ParticipantsPatients: Treatment Group: 17 patients 100% female, 81% white, mean age 50.5 years; Years of FMS 11.8 (4.6)

Control Group: 15 patients, 100% female, 80% white, mean age 47 years; Years of FMS 12.3 (7.9)

Inclusion: ACR 1990 criteria for FM, moderately symptomatic with respect to pain intensity (FIQ pain score >3, FIQ physical impairment score ≥2), female

Exclusion: Peripheral neuropathy, diabetes mellitus, demyelinating disorders, inflammatory rheumatic diseases


InterventionsTreatment Group: CBT: telephone sessions: time-contingent activity pacing, pleasant activity scheduling, relaxation, automatic thoughts and pain, cognitive restructuring, stress management + workbook (0,5h/week), total: 3 hours

Control Group: TAU: customary care received from subject’s treating physician

Co-medication allowed: Stable doses and regimen of medication throughout the study, 48-hour washout of NSAIDs prior to nociceptive flexion reflex threshold test

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: FIQ pain (VAS) 0-10

Self reported negative mood: Patient Health Questionnaire 8-item depression scale (PHQ-8) 0-24. Post-treatment data not reported and not provided on request.

Self reported disability: FIQ Physical Impairment 0-10

Acceptability: Total drop out rate

Secondary Outcomes

Self reported self efficacy pain: Not assessed

Self reported fatigue: FIQ fatigue 0-10; data provided on request

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: FIQ total 0-100


Notes1. Reasons for dropout (post-treatment and follow-up):

Treatment Group: 1x refused further follow-up, 1x nociceptive flexion reflex threshold test too painful; Control Group: 1x refused further follow-up, 1x nociceptive flexion reflex threshold test too painful

2. Attendance rates: Not reported

3. Responder analysis: 33% of the patients in the CBT group and 15% of the patients in the TAU group reported a ≥ 14% reduction of the FIQ total score

4. Funding sources and declaration of interest of the primary researchers: No details of funding reported. Dr. Ang has received consulting fees (less than $10,000) from Eli Lilly


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo detailed information

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo Intention-to-treat analysis

Selective reporting (reporting bias)High riskNot all outcomes reported and not provided on request

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: Europe (Sweden). Single-centre, recruitment in occupational and primary health clinics, outpatient based

Study design: Parallel

Duration therapy: 6 weeks

Follow-up: 3 and 6 months

Analysis: ANOVA (FIQ), MANOVA (QOLS-S, FAI, SELF pain, SELF function, SELF other, 6-min walk, chair test, myalgic score), if omnibus F significant ANOVA on individual outcomes, independent group t-tests, paired different t-tests for within group change


ParticipantsPatients: Treatment group: 28 patients; Control group: 30 patients; Total sample:100% female, 99% white, mean age 46.5 years; Duration of symptoms not reported

Inclusion: ACR 1990 criteria for FM, normal results in laboratory tests (haemoglobin, free thyroxine, erythrocyte sedimentation rate, antinuclear antibodies, rheumatoid factor, creatine phosphokinase), understand Swedish

Exclusion: Other rheumatic diseases


InterventionsTreatment Group: CBT, group: education, relaxation, assertiveness training, coping strategies, problem solving techniques (1x1.5h/week), total: 9h

Control Group: Delayed treatment control

Co-medication allowed: Yes, not controlled for

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: FIQ pain 0-10; SD not reported and not provided on request; SDs calculated by imputation method

Self reported negative mood: FIQ depression 0-10; SD not reported and not provided on request; SDs calculated by imputation method

Self reported disability: FIQ physical impairment 0-10; SD not reported and not provided on request; SDs calculated by imputation method

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Self-Efficacy (SES) pain scale 500-50; SD not reported and calculated by reported P-value

Self reported fatigue: FIQ fatigue 0-10; SD not reported and not provided on request; SDs calculated by imputation method

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: FIQ total 0-80; SD not reported and not provided on request; SDs calculated by imputation method


Notes1. Study arm CBT plus physical therapy not used for comparison

2. Reasons for drop-out

-Total sample: 6x did not return for retesting (no separate data reported

-Experimental groups: 7x did only attend 1 or 2 classes

3. Attendance rates: Not reported

4. Responder analysis: None

5. Funding sources and declaration of interest of the primary researchers: No details reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo detailed information

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
High riskNo Intention-to-treat analysis

Selective reporting (reporting bias)High riskExcept FIQ-subscale scores all other outcomes not reported in detail at follow-up and not provided on request

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: Europe (Spain). SIngle centre, recruitment in university pain clinic, outpatient based

Study design: Parallel

Duration therapy: 12 weeks

Follow-up: None  

Analysis: T-tests and Chi2 analysis to compare treatment conditions in demographic and pre-treatment outcome variables, paired t-tests to evaluate changes in each condition treatment, univariate analyses to compare between treatments, percentage of patients that experienced a significant change in pain intensity was evaluated, cut-off of 30% accepted as indicator of clinically important improvement, evaluation of Pearson correlation between hypnotisability and pre-post-treatment differences


ParticipantsPatients: Treatment Group: 18 patients, 94% female, race not reported, mean age 43.0 years; pain duration 10.2 (10.7) years

Control Group: 12 patients, 86% female, race not reported, mean age 49.6 years; pain duration 7.1 (5.6) years

Inclusion: ACR 1990 criteria for FM, age between 18 years and less than 60 years, having a minimum of 6 months history of chronic pain, having at least 6 years of education

Exclusion: One or more additional severe chronic medical pain conditions, significant suicidal ideation, severe psychopathology (e. g. psychosis), moderate to severe cognitive impairment, presence of pending litigation


InterventionsTreatment Group: CBT, group: didactic presentation of information about FMS and theory of pain perception, relaxation training, cognitive restructuring, assertiveness training, behavioral goal setting, problem solving, training in outcome generalization, maintenance of gains, audio CD of a relaxation exercise to listen to at home (1.5h/week), total: 18h

Control Group: TAU: Pharmacological treatment including analgesics, antidepressants, sedatives, myorelaxants

Comedication allowed: Standard medication management

Other Cotherapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: Numeric Pain Rating Scale (NPRS) 0-10 NR

Self reported negative mood: FIQ depression 0-10; Data provided on request

Self reported disability: FIQ physical impairment 0-10; Data provided on request

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Not assessed

Self reported fatigue: FIQ fatigue 0-10; data provided on request

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: FIQ total 0-100


Notes1. Study arm CBT plus hypnosis (not used for comparison)

2.Reasons for dropout: Not reported

3. Attendance rates: Not reported

4. Responder analysis: None

5. Funding sources and declaration of interest of the primary researchers: No details reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo detailed information

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
High riskNo Intention-to-treat analysis

Selective reporting (reporting bias)Low riskAll outcomes reported or provided on request

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: Europe (Spain). Single centre, recruitment in university pain clinic, outpatient based

Study design: Parallel

Duration therapy: 14 weeks

Follow-up: 3 and 6 months 

Analysis: T-tests with Bonferroni correction. Linear mixed model analysis (interaction between time and group) for outcome measures


ParticipantsPatients: Treatment Group: 34 patients, 94% female, race not reported, mean age 50 years; pain duration 13.6 (9.2) years

Control Group: 30 patients, 100% female, race not reported, mean age 48.7 years; pain duration 11.6 (6.9) years

Inclusion: ACR 1990 criteria for FM, age between 18 years and less than 65 years

Exclusion: One or more additional severe chronic medical pain conditions, significant suicidal ideation, severe psychopathology (e.g. psychosis), moderate to severe cognitive impairment


InterventionsTreatment Group: CBT, group (except session 2):Education on FMS and pain perception theory (Session 1, autogenic training (session 2), cognitive restructuring training (sessions 3-5), cognitive behavioural training for primary insomnia (sessions 6-8), assertiveness training (sessions 9-10), activity pacing and pleasant activity scheduling training (sessions 11-12), behavioral goal setting (session 13), life values and relapse training (session 14); audio CD of autogenic training to practice at home;1 session/week for 4 weeks (2h/week), total:28h

Control Group: TAU: Pharmacological treatment including analgesics, antidepressants, anticonvulsants and myorelaxants, as appropriate

Co-medication allowed: Standard medication management

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: Numeric rating scale 0-10

Self reported negative mood: Hospital Anxiety and Depression Scale (HADS) total score 0-42

Self reported disability: FIQ physical impairment 0-10: Data provided on request

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Not assessed

Self reported fatigue: FIQ Fatigue 0-10; Data provided on request

Self reported sleep problems: SF-36 sleep problems index 50-0

Self reported disease-specific health-related quality of life: FIQ total score 0-100


Notes1. Treatment arm CBT plus hypnosis not used for comparison

2. Reasons for dropout: Not reported

3. Attendance rates: Patients in CBT groups attended a mean of 12.3 (SD 1.7) sessions

4. Responder analysis: 8.8% of the patients in the CBT group reported a ≥30% pain reduction at final treatment and 17.6% at six months follow-up. 16.7 % of the patients in the TAU group reported a ≥30% pain reduction at final treatment and 13.3% at six months follow-up. 55.9% of the patients in the CBT group reported a ≥14% reduction of the FIQ total score at final treatment and 58.8% at six months follow-up. 23.3% of the patients in the TAU group reported a ≥14% reduction in the FIQ total score at final treatment and 20% at six months follow-up.

5. Funding sources and declaration of interest of the primary researchers: No details reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details reported

Allocation concealment (selection bias)Unclear riskNo details reported

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis by last observation carried forward method

Selective reporting (reporting bias)Low riskAll outcomes reported or provided on request

Blinding of outcome assessorLow riskPsychologist blinded to participants' group assignment


MethodsStudy setting: North America (USA). Newspaper recruitment, University centre, outpatient based

Study design: Parallel

Duration therapy: 6 weeks

Follow-up: 6 months

Analysis: 3 (group) x 2 (post-treatment versus follow-up) ANCOVA adjusted for baseline values, pair-wise tests


ParticipantsPatients: Treatment Group: 16 patients, 94% female, 94% white, mean age 50 years; duration of symptoms not reported

Control Group: 11 patients, 100% female, 92% white, mean age 48.3 years; duration of symptoms not reported

Inclusion: ACR 1990 criteria for FM, aged 21 to 65 yrs,meet structured interview criteria for insomnia, at least 60 minutes of total nocturnal wake time on average over 1 week of sleep log monitoring

Exclusion: Pregnancy, breastfeeding, not practicing contraception, co-morbid sleep-disruptive medical condition, Axis I depressive (other than dysthymia), anxiety or substance abuse disorder, severe hypnotic dependence, symptoms of sleep apnoea, restless legs syndrome, circadian rhythm disorder, apnoea-hypopnoea index or periodic limb movement-related arousal index of 15 or more per hour


InterventionsTreatment Group: CBT, group: Insomnia therapy with education and stimulus control (1x1h/wk), total: 6h

Control Group: TAU

Co-medication allowed: Yes

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: McGill Pain Questionnaire total score (MPQ) 0-78

Self reported negative mood: Profile of mood states (POMS), range 0- 260

Self reported disability: SF-36 physical functioning 50-0 not reported and not provided on request

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Not assessed

Self reported fatigue: Not assessed

Self reported sleep problems: Insomnia Symptom Questionnaire (ISQ) 0-57

Self reported disease-specific health-related quality of life: Not assessed


Notes1. Treatment arm sleep hygiene not used for comparison

2. Reasons for dropout: Not reported

3: Attendance rates: 16/18 in the CBT group attended ≥1 treatment session

4: Responder analysis: None

5. Funding sources and declaration of interest of the primary researchers: The study was supported by grant R21- AR052368 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (Dr Edinger). Dr Edinger received honoraria from Fisson Communications, Sepracor, and Axis Healthcare; and Dr Rice has provided expert testimony and medical record review as a defence expert in FM for several attorneys (he is willing to provide further information about the financial details of the testimony on appropriate request)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo detailed information

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
High riskNo intention-to-treat analysis

Selective reporting (reporting bias)High riskNot all outcomes reported and not provided on request

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: South America (Brazil). Single centre, recruitment in rheumatology university clinic, outpatient based

Study design: Parallel

Duration therapy: 10 weeks

Follow-up: 3 months

Analysis: Chi2 or student t-test analyses between groups, analyses of variance (repeated measures) between groups at different time points


ParticipantsPatients: Treatment Group: 30 patients, 100% female, 80% Caucasian, mean age 45 years; disease duration 3.5 (2.4) years

Control Group: 30 patients, 100% female, 77% Caucasian, mean age 46 years; disease duration 3.7 (4.8) years

Inclusion: ACR 1990 criteria for FM, age 18 to 65 years, female, at least 4 years of formal education (elementary school), patients had not received any kind of treatment for their disease

Exclusion: Other rheumatic diseases, known hypersensibility to amitriptyline, cyclobenzaprine or paracetamol, use of psychotropic drugs, psychiatric diseases, work-related litigation


InterventionsTreatment Group: CBT,group: progressive muscle relaxation training, cognitive restructuring, stress management + routine medical visits (3h/week), total: 30h

Control Group: TAU: Medication and routine medical visits

Co-medication allowed: Patients in both groups: amitriptyline 12.5mg/day during first week, then increase to 25mg/day, those with intolerance or side effects were given cyclobenzaprine 5mg/day, use of paracetamol was allowed 750mg if patients had pain (max. dose of 2250mg/day)

Other Co-therapies: None


OutcomesPrimary Outcomes

Self reported pain: VAS pain 0-10

Self reported negative mood: Beck Depression Inventory (BDI) 0-54

Self reported disability: FIQ 0-10; data provided on request

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Not assessed

Self reported fatigue: FIQ fatigue 0-10; data provided on request

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: FIQ total 0-100


Notes1. Reasons for dropout:

- Experimental group:2x move to another city, 3x gave up after 1st, 5th or 6th CBT session

- Control group: 1x use of psychotropic drugs, 3x gave up study at different times

2: Attendance rates: All completers in the CBT group attended more than 80% of the sessions.

3. Responder analysis: None

4. Funding sources and declaration of interest of the primary researchers: No details reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPatients were randomised by drawing lots with concealed allocation

Allocation concealment (selection bias)Low riskYes (see above)

Incomplete outcome data (attrition bias)
All outcomes
High riskNo intention-to-treat analysis

Selective reporting (reporting bias)Low riskAll outcomes reported or provided on request

Blinding of outcome assessorLow riskEvaluation performed by a physiotherapist who was blind to treatment allocation


MethodsStudy setting: North America (USA).Single centre, paediatric rheumatology non-university clinic, outpatient based

Study design: Cross-over

Duration therapy: 8 weeks

Follow-up: None

Analysis: T- tests for pre-treatment differences, repeated measures ANOVA 2 (baseline versus time 2) x 2 (CBT versus control), within-subjects effects, difference between 2 conditions based upon sequence of treatment delivery by analysis with proc mixed model, effect sizes (time 1 to time 2, time 2 to time 3, time 1 to time 3)


ParticipantsPatients: Total group: 14 patients each in both groups; 100% female, 93% white, mean age 15.8 years; duration of symptoms not reported

Inclusion: Age between 13 and 17 years, Juvenile Primary Fibromyalgia criteria, stabilization on medication for at least 4 weeks prior to enrolment, VAS pain 0-10 score at least 3 an a 10 cm VAS, functional disability score greater than 7 (mild disability)

Exclusion: Co-morbid rheumatic disease, developmental delay or impairment, major depressive disorder


InterventionsTreatment Group: CBT, single, group and with parents: Relaxation, distraction, activity pacing, cognitive and problem-solving techniques (1x1.5h/week), total: 12h

Control Group: Active control, single: Self-monitoring with diary

Co-medication allowed: Yes (standard medical care)

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: VAS pain 0-10

Self reported negative mood: Children’s Depression Inventory (CDI) T score

Self reported disability: Functional Disability Inventory (FDI) 0-60

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Pain Coping Questionnaire (PCQ) 1-5

Self reported fatigue: Not assessed

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: Not assessed


Notes1. Reasons for dropout:

- Treatment Group: 1x due to distance

- Control Group:1x no contact, 1x family issues

2. Attendance rates: 90% of all participants attended all sessions

3.Responder analysis: None

4. Funding sources and declaration of interest of the primary researchers: Supported by grants of the Cincinnati Children's Hospital Reserach Foundation and National Institutes Helath Grant 1P60AR47784-01)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated pseudo-random number list

Allocation concealment (selection bias)Low risk1:1 allocation ratio for the subjects as a single block was used. An assistant who was blinded enrolled the subject and opened a sealed envelope with the subject's study number

Incomplete outcome data (attrition bias)
All outcomes
High riskNo intention-to-treat analysis

Selective reporting (reporting bias)Low riskAll outcomes reported

Blinding of outcome assessorLow riskAn assistant and a rheumatologist who were blinded


MethodsStudy setting: North America (USA). Multicentre paediatric university rheumatology centres, outpatient based

Study design: Parallel

Duration therapy: 8 weeks

Follow-up: 6 months

Analysis: Mixed modelling for repeated measures with fixed factors being group, time and group-by-time interaction, intention-to-treat


ParticipantsPatients: Treatment Group: 57 patients; 95% female, 84% white, mean age 15.2 years; disease duration 3.3 (3.1) years

Control Group: 57 patients; 90% female, 97% white, mean age 14.9 years; disease duration 2.5 (1.8) years

Inclusion: Juvenile FM classification criteria determined by a paediatric rheumatologist, age 11 to 18, stable medication for 8 weeks, willing to continue receiving stable medication for the duration of the study, average pain severity ≥4 on VAS 0-10 based on 1 week of daily pain diaries, score of >7 on FDI

Exclusion: Other rheumatic disease (juvenile arthritis, lupus), documented developmental delay, current panic disorder or major depression or lifetime bipolar disorder or psychosis, use of opioids


InterventionsTreatment Group: CBT, individual: Education about rationale for behavioural pain management, training in relaxation, distraction, activity pacing, problem solving, using calming statements, relapse prevention strategies; parents included in 3 out of 8 sessions: training in behavioural management techniques (1x45min/week), total: 6h

Control Group: Active control: FMS education, individual: education and discussion about FM, pain medications, general lifestyle issues (diet, sleep, exercise), impact of juvenile’s FM on patient’s lifestyle; parents attended 3 out of 8 sessions (1x45min/week), total: 6h

Co-medication allowed: Yes, 9 patients were prescribed new antidepressant medication

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: VAS pain 0-10

Self reported negative mood: CDI T score

Self reported disability: Functional Disability Index (FDI) 0-60

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Not assessed

Self reported fatigue: Not assessed

Self reported sleep problems: VAS sleep 0-10

Self reported disease-specific health-related quality of life: Not assessed


Notes1. Reasons for dropout:

- Treatment group: 1x time constraints, 1x family reasons, 1x loss to follow-up, 1x psychiatric hospitalisation for non-study related reasons, 6 months follow-up 3x lost to follow-up;

-Control group: 2x dropped out before attending any sessions, other reasons for drop-out not reported, 6-months follow-up: 3x lost to follow-up

2: Attendance rates: Not reported

3. Responder analysis: 14.0% in the CBT-group and 8.6% in the control group reported a ≥30% pain reduction

4. Funding sources and declaration of interest of the primary researchers:Supported by the National Institute of Arthtitis and Musculoskeletal and Skin Diseases grant R01-AR-0500208 to Dr. Kashikar-Zuck. Dr Passo received consulting fees, speaking fees and/or honoraria from Pfizer (less than 10 000$)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomization based upon a computer generated randomisation list, stratified by site

Allocation concealment (selection bias)Low riskTreatment allocation by biostatistician

Incomplete outcome data (attrition bias)
All outcomes
High riskIntention-to-treat-analysis reported, but no imputation methods for dropouts used

Selective reporting (reporting bias)Low riskAll outcomes reported

Blinding of outcome assessorLow riskStudy uses a single-blind design, assessment staff were all blinded to the patients' treatment condition


MethodsStudy setting: North America (Canada). Single university centre, self referral or referral by rheumatologists, outpatient based

Study design: Parallel

Duration therapy: 12 weeks

Follow-up: 3 months

Analysis: ANOVA with repeated measures (group versus time), significant results were examined using Tukey multiple comparisons, independent t-tests and Chi2 tests to compare demographic and baseline variables 


ParticipantsPatients: Treatment group; 48 patients; 100% female, race not reported, mean age 44.9 years; duration of symptoms 10.9 (10.7) years

Control Group: 39 patients; 100% female, race not reported, mean age 47.3 years; duration of symptoms 9.6 (7.9) years

Inclusion: ACR 1990 criteria for FM, age between 18-65, diagnosis confirmed by rheumatologist, female

Exclusion: Any conditions that precluded ability to exercise (severe cardiac arrhythmia, dizziness, severe shortness of breath), inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis


InterventionsTreatment Group: CBT, group: Self management strategies, information about cause of FMS, goal setting, maximizing energy for household chores or personal activities, pain or fatigue coping strategies, benefits of exercise, evaluating alternative therapies, barriers to behavior change (1.5h-2h/week), total: 18h-24h

Control Group: Delayed treatment control

Co-medication allowed: Instruction not to change medication, but if participants documented changes in their usual treatment and it was not major they remained in the study

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: FIQ pain 0-10 not reported

Self reported negative mood: FIQ depression 0-10 not reported and not provided on request

Self reported disability: FIQ physical impairment 0-10 not reported and not provided on request

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Chronic Pain Self Efficacy Scale (CPSS) pain: 10-0

Self reported fatigue: FIQ fatigue 0-10 not reported and not provided on request

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: FIQ 0-80


Notes1. Study arms exercise and exercise plus education not used for comparison)

2. Reasons for dropout:

- Treatment and control group: End of treatment and follow up: Not reported

3. Attendance rate: 83.3% (SD 10.8) of the sessions in CBT group were attended

4. Responder analysis: None

5. Funding sources and declaration of interest of the primary researchers: Funded by grants from the Medical Services Incorporated Foundation and from the Health Services Research and Innovation Fund, Alberta Health


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom assignment was done in blocks of 4 to 16 subjects

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis by baseline carried forward method

Selective reporting (reporting bias)High riskNot all outcomes reported and not provided on request.

Blinding of outcome assessorLow riskBoth assessors were blinded to the subjects' group randomisation


MethodsStudy setting: Europe (Spain). Multicentre, general practitioners, outpatient based

Study design: Parallel

Duration therapy: 8 weeks

Follow-up: None

Analysis: T-tests and Chi2 to examine baseline differences, repeated measures analysis of variance (factor 1: intervention and control, factor 2: pretreatment and post-treatment), comparison of baseline differences between responders and non-responders


ParticipantsPatients: Treatment Group: 108 patients; 97% female, race not reported, mean age 55.2 years; years since diagnosis 15.2 (11.7)

Control Group: 108 patients; 98% female, race not reported, mean age 55.4 years; years since diagnosis 14.3 (10.6)

Inclusion: ACR 1990 criteria for FMS, age 18 to 75 years

Exclusion: Diagnosis of FM based on ACR 1990 criteria, cognitive impairment, presence of physical/psychiatric limitations that impeded participation in the study assessments, life expectancy of less than 12 months, absence of schooling


InterventionsTreatment Group: CBT: information about symptoms, usual course, comorbid medical conditions, potential causes of illness, influence of psychosocial factors on pain, current pharmacological and non-pharmacological treatments, benefits of regular exercise, autogenic training (2h/week), total: 16h

Control Group: TAU: pharmacological treatment and counselling about aerobic exercise

Co-medication allowed: Yes

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: FIQ pain 0-10

Self reported negative mood: FIQ depression 0-10

Self reported disability: FIQ physical impairment 0-10

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Not assessed

Self reported fatigue: FIQ general fatigue 0-10

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: FIQ total 0-80


Notes1. Reasons for dropout (both groups): 16x not interested in the study, 2x family burden, 2x not able to comply with the treatment schedule, 1x relocation

2. Attendance rates: not reported

3:Responder analysis: 35% of the patients in the CBT groups and 17% of the patients in the TAU group reported a ≥20% reduction of the FIQ total score at final treatment

4. Funding sources and declaration of interest of the primary researchers:The research project and Nuria Martınez’s pre-doctoral contract were funded by a grant from the “Agencia d’Avaluacio´ de Tecnologia i
Recerca Mediques” (AATRM 077/25/06). Juan V. Luciano received a postdoctoral contract from the “Instituto de Salud Carlos III” (Red RD06/0018/0017)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated randomisation list

Allocation concealment (selection bias)Unclear riskNo details reported

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis by baseline carried forward method

Selective reporting (reporting bias)Low riskAll outcomes reported

Blinding of outcome assessorLow riskResearch assistant was not involved in the treatment and was blind to group allocation


MethodsStudy setting: Europe (Spain). Single centre, university rheumatology and pain department, outpatient based

Study design: Randomized, parallel

Duration therapy: 6 weeks

Follow-up: No

Analysis: T-test, Mann-Whitney U, Chi² to compare baseline measures, ANCOVA 2 (alerting signal) x 3 (orienting cue) x 2 (congruency) x 2 (time) with age as covariate, repeated measures ANOVA (CBT vs SH x time, pre vs post-treatment), calculation of effect sizes (Cohen’s d), paired comparisons of sign. effects with student’s t test, Reliable Change Index for clinical variables that changed over time as a result of therapy and Pearson’s analysis


ParticipantsPatients: Treatment Group: 20 patients, 100% female, race not reported, mean age 44.0 years; duration FMS 4.2 (3.4) years

Control Group: 20 patients, 100% female, race not reported, mean age 50.2 years; duration FMS 4.7 (4.3) years

Inclusion: ACR 1990 criteria for FM, criteria for insomnia

Exclusion: 25 to 60 years, insomnia/cognitive dysfunction were better explained by being pregnant, medical history of significant head injury, neurological disorder, major concomitant medical condition, major depressive disorder with suicide ideation, other major axis I diagnosis, symptoms of sleep disruptive co-morbidities with insomnia, apnoea-hypopnoea index or periodic limb movement-related arousal index of 15 or more per hour of sleep, severe hypnotic dependence (use of hypnotic in a higher than recommended dosage or repeated episodes of rebound insomnia on withdrawal), being treated with another psychological or physical therapy at the moment of the study


InterventionsTreatment Group: CBT, group: Education, sleep restriction, stimulus control instructions, relaxation training, cognitive therapy for dysfunctional beliefs related to insomnia (1.5h/week), total: 9h

Control Group: Active control: Sleep hygiene, group: education sleep hygiene rules (1,5h/wk), total: 9h

Co-medication allowed: Stable doses of medication

Other Co-therapies: None


OutcomesPrimary Outcomes

Self reported pain: MPQ VAS pain 1-10

Self reported negative mood: Hospital Anxiety and Depression Scale (HADS) subscale depression 0-21

Self reported disability: FIQ impairment 0-10 not reported and not provided on request

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Not assessed

Self reported fatigue: FIQ fatigue 0-10 not reported and not provided on request

Self reported sleep problems: Pittsburgh Sleep Quality Index (PSQI) 0-21

Self reported disease-specific health-related quality of life: FIQ 0-100


Notes1. Reasons for dropout:

-Treatment Group: 1x did not receive CBT due to changes in work time, 1x did not attend assessment at end of treatment

- Control Group: 2x did not attend assessment at end of treatment

2: Attendance rates: Not reported

3. Responder analysis: 60% of patients in the CBT-group and 30% of the patients in the control group clinically significant (% not reported) reduction of the FIQ daily functioning score at end of treatment

4. Funding sources and declaration of interest of the primary researchers: The study was financially supported by the Spanish Ministry of Science and Innovation (research projects SEJ2006-07513, PSI2008-03595PSIC and PSI2009-1365PSIC)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskSimple randomisation (1:1) was implemented by a computerised number generator designed by a researcher with no clinical involvement in the trial

Allocation concealment (selection bias)Low riskYes (see above)

Incomplete outcome data (attrition bias)
All outcomes
High riskNo intention-to-treat analysis

Selective reporting (reporting bias)High riskNot all outcomes reported and not provided on request

Blinding of outcome assessorLow riskThe assessment of the outcome measures was performed by an examiner who was blinded to group assignment


MethodsStudy setting: North America (USA). Single centre university psychiatry department, outpatient based, referral by community, private or university rheumatology clinics, FMS support groups

Study design: Parallel

Duration therapy: 10 weeks

Follow-up: 6 months

Analysis: MANOVA between groups at pre-treatment on clinical criteria and intervening variables, MANOVA between treatment conditions and across time (pre-, post-treatment, follow-up periods) on clinical criteria and intervening variables (helplessness, active coping, passive coping, quality of social support), change score correlations to see whether helplessness and passive coping mediate changes, regression analysis (predictors: helplessness, passive coping)


ParticipantsPatients: Total group: 89% female, 86% white, mean age 53.1 years; CBT group 36 patients, control group 35 patients; duration of symptoms not reported

Inclusion: Diagnosis of FM confirmed by rheumatologist according to ACR 1990 criteria, stabilization on medication for at least 2 months prior to the study, support person who would be willing to participate in the study

Exclusion: Concomitant rheumatologic conditions, cardiovascular disease, central nervous system disorders, psychosis, bipolar illness


InterventionsTreatment Group: CBT, group: education, relaxation, activity pacing, pain coping, involvement of support person reinforcing adherence to protocol (1x1.5h/week), total: 15h

Control Group: Attention control, group: lectures, group discussion, support (1.5h/week), total: 15h

Co-medication allowed: Yes, not controlled for

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: Pain index composed by (a) pain scale of the FIQ, b) number of discrete body areas endorsed as painful form a human figure drawing, c) pain rating index of MPQ, d) flare index: frequency times the squared average intensity of pain flares over previous month; no minimum and maximum scores available

Self reported negative mood: Center for Epidemiological Studies-Depression Scale (CES-D) 0-60

Self reported disability: Quality of well-being 1-0

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Pain Management Inventory Subscale active coping

Self reported fatigue: Not assessed

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: Not assessed


Notes1. Reasons for dropout: not reported

2. Attendance rates: Not reported

3: Responder analysis: None

4. Funding sources and declaration of interest of the primary researchers: Multipurpose Arthritis and Musculoskeletal Diseases Center Grant AR40770 and grant from the General Clinical Research Centers M01RR00827 of the MCRR from the US National Institute of Health


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskSubjects were randomly assigned with the aid of a random number table from within blocks to the interventions

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
High riskNo intention-to-treat analysis

Selective reporting (reporting bias)Low riskAll outcomes reported

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: North America (USA). Multicentre, recruitment via health maintenance organisation, university psychology department, outpatient based

Study design: Parallel

Duration therapy: 12 months and 2 weeks

Follow-up: None

Analysis: Chi2 test and ANOVA to examine pre-existing differences on demographic characteristics, ANCOVA to examine 3 (group) x 2 (time of assessment) interactions


ParticipantsPatients: Treatment Group: 207 patients; 96% female, 85% Caucasian, mean age 55.1 years; duration of FMS symptoms 14.4 (14.2) years

Control Group: 193 patients; 94% female, 100% European, mean age 52.9 years; duration of FMS-symptoms 11.7 (12.1) years

Inclusion: ACR 1990 criteria for FM, diagnosis by a physician

Exclusion: Not reported


InterventionsTreatment Group: Self management education program: Social support and education, group: tasks aimed at promoting empathy and sharing coping techniques, health education in lecture format (2h/session), total: 20h

Control Group: Non-treatment control, details not reported (TAU?)

Co-medication allowed: NR

Other Co-therapies: NR


OutcomesPrimary Outcomes

Self reported pain: FIQ pain 0-10 not reported and not provided on request

Self reported negative mood: CES-D 0-60

Self reported disability: Not assessed

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: SES pain 100-0

Self reported fatigue: FIQ sleep 0-10 not reported and not provided on request

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: FIQ 0-100


Notes1. Study arm social support not used for comparison

2. Reasons for dropout:

- Control group: 42x no reason, 8x not interested, 5x moved, 9x inconvenience, 4x other, 4x surgery/illness

Control Group: 6x no reason, 8x not interested, 4x moved, 4x other, 1x surgery/illness

- Treatment Group: 207/165 (80%), reasons for dropout: 42x no reason, 8x not interested, 5x moved, 9x inconvenience, 4x other, 4x surgery/illness; Control Group: 193/170 (88%), reasons for dropout: 6x no reason, 8x not interested, 4x moved, 4x other, 1x surgery/illness

3: Attendance rates: Patients in the CBT group attended an average total of 8.4 (SD 6.2) of the 20 meetings

4: Responder analysis: None

5. Funding sources and declaration of interest of the primary researchers: NIH grant AR-440020


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo detailed information

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
High riskNo intention-to-treat analysis

Selective reporting (reporting bias)High riskNot all outcomes reported and not provided on request

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: Europe (Spain). Single centre, referral by general practitioners, rheumatology university, outpatient based

Study design: Parallel

Duration therapy: 8 weeks

Follow-up: 12 months

Analysis: Chi2 and Fisher exact tests to compare categorical variables between groups, t-test to compare means for independent variables, paired t-tests to compare paired variables, intention-to-treat


ParticipantsPatients: Total group: 100% female, race not reported, mean age not reported; 21 patients in CBT and 19 patients in control group; duration of symptoms not reported

Inclusion: ACR 1990 criteria for FM

Exclusion: Serious concomitant disease


InterventionsTreatment Group: CBT, group: Education, relaxation, coping with pain and daily activities, problem solving, prevention of relapses (1x2.5h/week), total: 20h

Control Group: Active control: pool and cycle ergometer aerobic training (5x45 min/week), total: 30h

Co-medication allowed: Flexible medication with NSAID, amitriptyline and acetaminophen allowed

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: VAS pain 0-10

Self reported negative mood: BDI 0-54

Self reported disability: SF 36 Physical functioning 50-0

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Chronic Pain Self Efficacy Scale (CPSS) 10-0

Self reported fatigue: VAS sleep 0-10

Self reported sleep problems: VAS fatigue 0-10

Self reported disease-specific health-related quality of life: FIQ 0-100


Notes1. Reasons for dropout:

-Treatment Group: 2x no subjective improvement with proposed treatment, 1x move, 2x did not complete entire evaluation

- Control Group: 2x concomitant illnesses, 2x did not complete entire evaluation

2. Attendance rates: 72.1% (SD 24.2) of the CBT sessions were attended

3.Responder analysis: None

4. Funding sources and declaration of interest of the primary researchers: No details reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomization by means of a random numbers table

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis by baseline carried forward method

Selective reporting (reporting bias)Low riskAll outcomes reported

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: North America (USA). Multicentre (2 community fitness facilities, one hospital wellness centre), outpatient based, recruitment via general practitioners, letters

Study design: Parallel

Duration therapy: 16 weeks

Follow-up: 6 months

Analysis: Paired t-test or Kruskal-Wallis for within-group changes, analyses of variance for multiple comparisons to compare mean changes scores across the groups, 2-sample t-test, Wilcoxon rank sum test and Fisher exact test to compare baseline values and demographic variables between completers and non-completers


ParticipantsPatients: Treatment group: 51 patients; 100% female, 93% White, mean age 51 years; years since diagnosis 6 (5)

Control Group: 50 patients; 100% female, 83% White, mean age 48 years; years since diagnosis 5 (4)

Inclusion: ACR 1990 criteria for FM, diagnosis confirmed by primary care physician, age 18-75 years

Exclusion: Medical conditions that limited a person’s ability to perform the exercise protocol or for whom moderate-level exercise was contraindicated


InterventionsTreatment Group: Self management education program, group: basic self-management techniques to accomplish daily activities, manage symptoms, suggested ways to incorporate wellness activities (2h/session): 16h

Control Group: Active control: Aerobic and flexibility exercise (1h/session), total: 32h

Co-medication allowed: Not reported

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: VAS pain 0-10

Self reported negative mood: BDI 0-54

Self reported disability: SF 36 physical function 50-0

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: SES pain 100-0

Self reported fatigue: FIQ fatigue 0-10

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: FIQ 0-100


Notes1. Study arms strength training, and combination a of strength training, aerobic, flexibility exercise not used for comparison

2. Reasons for dropout:

- Treatment Group: 7x dissatisfied with randomisation, 7x schedule conflicts, 6x lost to follow-up, 1x other health problems, 1x travel issues, 1x FMS pain

- Control Group: 5x lost to follow-up, 4x other health problems, 4x schedule conflicts, 1x travel issues, 1x in a randomisation group, 1x FMS pain

3: Attendance rates: Mean attendance rate 77% in CBT and 73% in aerobic exercise group

4. Responder analysis: 20% of the patients in the CBT group and 25% of the patients in the combined group (CBT plus exercise) reported ≥20% reduction of the FIQ-total score at final treatment

5. Funding sources and declaration of interest of the primary researchers: The study was supported by an Arthritis Foundation Investigator Award (Dr Rooks) and National Institutes of Health grants K23 AR48305 (Dr Rooks), RO3 AR047398 (Dr Rooks), K24 AR02123 (Dr Katz), P60 AR47782 (Dr Iversen and Katz), and RR01032 (Dr Gautan). Financial disclosure: None reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated single-page listings of random group assignment

Allocation concealment (selection bias)Low riskIndividual pages were placed in an opaque envelopes, sealed, numbered sequentially and stored in a locked cabinet

Incomplete outcome data (attrition bias)
All outcomes
High riskIntention-to-treat analyses (BOCF) reported, but only outcomes of completers reported

Selective reporting (reporting bias)Low riskAll outcomes reported

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: Europe (Sweden). Single centre, psychology university department, outpatient based; referral by general practitioners

Study design: Parallel

Duration therapy: 10 weeks

Follow-up: 6 months

Analysis: 3x2 repeated measures ANOVA (group: treatment, control, waiting list control group x test occasion: pre, post), 2x3 ANOVA (group: treatment, control x test occasion: pre, post, follow-up), one-tailed t-tests, Chi² tests


ParticipantsPatients: Total group: 100% female, race not reported, mean age 45 years; 18 patients each in CBT and control group; duration pain 3.4 (3.2) years in CBT and 4.1 (3.8) in control group

Inclusion: Diagnosis of FM in the past 2 years according to ACR 1990 criteria by rheumatologist, female, age between 18 and 64 years

Exclusion: Other serious illnesses (e.g. other rheumatic diseases), ongoing alcohol or drug abuse, receiving other therapies


InterventionsTreatment Group: CBT, single and group: education, problem solving, pain and self management (5x1h individual, 15x2h group), total: 120h

Control Group: Attention control, group: education, discussion (2x2 h individual, 15x2h group), total: 102h

Co-medication allowed: No

Other Co-therapies: No


OutcomesPrimary Outcomes

Self reported pain: MPQ total 0-78

Self reported negative mood: FIQ depressed mood 0-10 not reported and not provided on request

Self reported disability: FIQ disability 0-10 not reported and not provided on request

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: ASES pain: 100-10

Self reported fatigue: FIQ Fatigue 0-10 not reported and not provided on request

Self reported sleep problems: Karolinska Sleep Questionnaire (KSQ) sleep quality 0-75

Self reported disease-specific health-related quality of life: FIQ 0-80


Notes1. Waiting list control not used for comparison because of lack of follow-up assessment

2.Reasons for dropout (only for total sample reported): declined participation after randomisation

3. Attendance rates: Not reported

4. Responder analysis: None

5. Funding sources and declaration of interest of the primary researchers: No details reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details reported

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis by baseline carried forward method

Selective reporting (reporting bias)High riskFollow-up data not reported in total

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: Europe (Germany). Single rheumatology centre, inpatient based, recruitment from the regular patients of a hospital for rheumatic diseases

Study design: Parallel

Duration therapy: 5 weeks

Follow-up: 6 and 15 months

Analysis: Repeated measures analysis of variances, t-tests, effect-sizes, reliable change index


ParticipantsPatients: Treatment Group: 42 patients, 100% female, race not reported, mean age 47 years; duration pain 17.1 (7,1) years

Control Group: 21 patients, 100% female, race not reported, mean age 49 years; duration pain 15.6 (6.3) years

Inclusion: ACR 1990 criteria for FM

Exclusion: Inflammatory cause of the pain, neurologic complications, duration pain < 4 months, pregnancy, severe somatic diseases, major psychiatric disorder, problems with German language


InterventionsTreatment Group: Operant therapy: Education; structured time-contingent exercises, reduction of medication, increase of bodily activity, reduction of interference of pain with daily activities; reduction of health care utilisation; time contingent exercises and intake and reduction of medication, assertiveness training, 5 weeks: 75 h

Control Group: Active control: Education, antidepressants, passive physical therapy exercises: 5 weeks: 75 h

Co-medication allowed: Yes, intake management part of therapy

Other Co-therapies: Yes


OutcomesPrimary Outcomes

Self reported pain: Multidimensional Pain Inventory (MPI), pain intensity 0-6

Self reported negative mood: MPi affective distress 0-6

Self reported disability: MPI Interference 0-6

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: MPI self-efficacy 0-6

Self reported fatigue: Not assessed

Self reported sleep problems: Sleep behaviour (hours)

Self reported disease-specific health-related quality of life: Not assessed


Notes1. Reasons for dropout:

Treatment group: 1 x severe depressive episode, 1 x bipolar disorder

Control Group: no dropouts

2: Attendance rate: Not reported

3. Responder analysis: 65% of patients in the OBT group and 0% of the patients in the control group reported a clinically relevant reduction (based on the reliability of change index) of the MPI pain interference score at final treatment

4. Funding sources and declaration of interest of the primary researchers: No details reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo detailed information

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
High riskNo intention-to-treat analysis

Selective reporting (reporting bias)Low riskAll outcomes reported

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: Europe (Germany). Single university psychology centre, outpatient based; referral by rheumatologists

Study design: Parallel

Duration therapy: 15 weeks

Follow-up: 6 and 12 months

Analysis: MANOVA, ANOVA, t-tests, effect sizes


ParticipantsPatients: CBT Group: 42 patients,100% female, race not reported, mean age 49 years; duration pain 9.1 (8.5) years

Operant therapy Group: 43 patients, 100% female, race not reported, mean age 43 years; duration pain 9 (10.1) years

Control Group: 40 patients, 100% female, race not reported, mean age 48 years; duration pain 8.7 (8.8) years

Inclusion: ACR 1990 criteria for FM, pain for a period of at least 6 months, married, willingness of the spouse to participate, ability to complete the questionnaires and understand the treatment components

Exclusion: Inflammatory rheumatic diseases and any concurrent major somatic disease (e.g. cancer, diabetes)


InterventionsTreatment Group: CBT: Problem-Solving, stress and pain coping strategies, relaxation, education, homework. 15 weekly 2-hour sessions: 30 hours

Operant therapy: Changing observable pain behaviours, punishment, video feedback of expressions of pain, contingent positive reinforcement of pain-incompatible behaviours, time contingent exercises and intake and reduction of medication, increase of bodily activity, role-plays,15 weekly 2-hour sessions: 30 hours

Control Group: Attention control: general discussions in groups around medical and psychosocial problems of FM,15 weekly 2-hour sessions: 30 hours

Co-medication allowed: Yes, intake management part of therapy

Other Co-therapies: Yes


OutcomesPrimary Outcomes

Self reported pain: MPI, pain intensity 0-6

Self reported negative mood: MPI Affective Distress 0-6

Self reported disability: FIQ physical impairment 0-10

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Pain-related self statements scale (PRSS) active coping scale range; data provided on request

Self reported fatigue: FIQ fatigue 0-10. Data provided on request

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: FIQ-Total 0-8, data provided on request


Notes1. Reasons for dropout:

CBT Treatment Group: 2x depression,

OBT Treatment Group: 2x Major depression, 1x lack of motivation

Control Group: 20xdetoriation of symptoms

2: Attendance rate: 95.7% of the sessions were attended and 94.5% of the homework was completed in the OBT group. 86.8% of the sessions were attended and 94.3% of the homework was completed in the CBT group.

3. Responder analysis: 53.5% of patients in the OBT group, 45.2% of the patients in the CBT group and 5.0% of the patients in the control group reported a ≥ 50% pain reduction at 12 months follow-up. 56.1% of patients in the OBT group, 36.1% of the patients in the CBT group and 7.5% of the patients in the control group reported a ≥ 50% reduction of the FIQ physical impairment score at 12 months follow-up (Thieme 2007)

4. Funding sources and declaration of interest of the primary researchers: This study was supported by grants from the Deutsche Forschungsgemeinschaft to KT (Th 899-1/2 and 899-2/2) and HF (FL 156/26, Clinical Research Unit 107 'Learning, plasticity and pain'), the Max-Planck Award for International Cooperation to HF, and the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases to DCT (AR44724 and AR 47298)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo detailed information

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis by last observation carried forward method

Selective reporting (reporting bias)Low riskAll outcomes reported or provided on request

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: Europe (Netherlands). Single university psychology centre, outpatient based; referral by rheumatology department of general hospital

Study design: Parallel

Duration therapy: 6 weeks

Follow-up: 6 and 12 months follow-up

Analysis: Comparisons between groups (baseline): Univariate analysis of variance, chi-square. Group differences: ANCOVA, MANCOVA. Reliability of change index


ParticipantsPatients: Treatment Group: 49 patients, 93% female, race not reported, mean age 45 years; duration pain 10.4 (7.7) years

Control Group: 43 patients, 82% female, race not reported, mean age 43 years; duration pain 10.2 (8.8) years

Inclusion: ACR 1990 criteria for FM, age 18-65 years

Exclusion: Illiteracy, pregnancy, substance abuse, involvement in any litigation concerning disability income, medical disorders and acute diseases, use of supportive equipment for ambulation, severe psychopathology


InterventionsTreatment Group: CBT: Education and Information, reconceptualization, skills acquisition and generalization phase. Relaxation, Homework.12 sessions a 90 min: 18 hours

Control Group: Active control: Education and information on chronic pain; physical exercise, intensity and duration not reported, at the end of the session; 12 sessions a 90 min: 18 hours

Co-medication allowed: Not reported

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: McGill Pain Questionnaire (MPQ), present rating intensity 0-100

Self reported negative mood: Beck Depression Inventory (BDI) 0- 63

Self reported disability: Not assessed

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Coping strategies questionnaire (CSQ) 7-1

Self reported fatigue: Not assessed

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: Not assessed


Notes1. Waiting list control not used for comparison, because outcomes not reported at follow-up

2. Reasons for dropout:

- CBT group: 6x by treatment staff because of group cohesion difficulties: 3x absence during 3 consecutive sessions: 1x worsening of health condition

- WLC: 1x refusal to comply with assessments

3: Attendance rates: Not reported

4. Responder analysis: 23.9% of the patients in the CBT group and 35.9% of the patients in the control group reported a clinically-relevant change (based on the reliability of change index) in the composite main outcome measure (pain coping and control, relaxation, tension, headache) at final treatment.

5. Funding sources and declaration of interest of the primary researchers: Supported by grant 28-2055 from the Dutch Prevention Fund


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo detailed information

Allocation concealment (selection bias)Unclear riskNo detailed information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUnclear information

Selective reporting (reporting bias)High riskNot all CSQ subscales reported

Blinding of outcome assessorUnclear riskNo detailed information


MethodsStudy setting: Europe (Norway). Single centre, Physical medicine and psychiatry centre, outpatient based; recruitment from local patient association and physical outpatient clinics

Study design: Parallel

Duration therapy: 14 weeks

Follow-up: 4 years

Analysis: Comparisons between groups (baseline): t-tests, ANOVA. Group differences: regression analysis. Kruskal-Wallis, Mann-Whitney. Responder analysis


ParticipantsPatients: Treatment Group: 20 patients 90% female, race not reported, mean age 44 years; symptom duration 11 (10) years

Control Group: 20 patients, 95% female, race not reported, mean age 46 years; symptom duration 11 (9) years

Inclusion: Diagnostic criteria of Smythe and Yunus

Exclusion: None


InterventionsTreatment Group: CBT: Stress Mangement Treatment (SMT): cognitive behavioural stress management package including relaxation and coping strategies. Total hours: 30

Control Group: TAU

Co-medication allowed: Allowed, but no details reported

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: Visual Analogue Scale pain (VAS pain) 0- 10

Self reported negative mood: Visual Analogue Scale Depression (VAS) 0-10

Self reported disability: Not assessed

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Not assessed

Self reported fatigue: Visual Analogue Scale (VAS) 0-10

Self reported sleep problems: Visual Analogue Scale (VAS) 0-10

Self reported disease-specific health-related quality of life: Not assessed


Notes1. Treatment arm aerobic exercise not used for comparison

2. Reasons for dropout:

- Treatment Group: 2 x Moved, 1x acquired Cancer, 1x transport problems, 2x initiated additional treatments (2). Follow-up: 1 x Moved, 1x not wishing to participate (1)

Control Group: 3x initiated additional treatments follow-up: 4x moved

3. Attendance rates: 68% in the CBT group

4. Responder analysis: 20% of the patients in the CBT group and 5% of the patients in the TAU group reported a ≥30% pain reduction at final treatment.

5. Funding sources and declaration of interest of the primary researchers: The study was supported by the Research Counsil of Norway (101417/320) and the Norwegian Fibromyalgia Association


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomization by drawing lots

Allocation concealment (selection bias)Unclear riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
Low riskITT

Selective reporting (reporting bias)Low riskAll outcomes reported

Blinding of outcome assessorUnclear riskNo details reported


MethodsStudy setting: North America (USA). Single university research centre, outpatient based, referral by primary or specialist care physician

Study design: Parallel

Duration therapy: 6 months

Follow-up: None

Analysis: Comparisons between groups (baseline): t-tests and Chi-quadrat, intention-to-treat approach, ANCOVA, responder analysis to anyone who reported 30% improvement in pain, an 0.50 SD in physical function via Fisher's exact test


ParticipantsPatients: Treatment Group: 59 patients, 95% female, 98% white, mean age 50 years; duration FM 9.5 (6.9) years

Control Group: 59 patients, 95% female, 97% white, mean age 51 years; duration FM 9.3 (6.1) years

Inclusion: ACR 1990 criteria for FM, age > 18 years, under standard medical care of a physician the last 3 months prior to assessment, possess basic computer literacy and access

Exclusion: Severe physical impairment, co-morbid medical illnesses capable of causing a worsening of physical functional status independent of FM, any present psychiatric disorder involving psychosis, suicide attempts or current risk, substance abuse, prior CBT for pain management, pending status associated with disability compensation or receipt of disability compensation in the last 2 years


InterventionsTreatment Group: Self management education program: Web-enhanced Behavioral Self-Management: website included 13 modules segregated into: educational lectures, education, behavioral and cognitive skills to help with symptom management, behavioral and cognitive skills to facilitate adaptive life style changes for managing FM. Each module featured a video lecture. Total hours: NA, but mean number of skills used every month and in total

Control Group: TAU

Co-medication allowed: Yes

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: Pain Severity scale of the Brief Pain Inventory (BPI) 0-10

Self reported negative mood: CED-S 0-60

Self reported disability: SF-36 Physical Functioning Scale 50-0

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Not assessed

Self reported fatigue: Multidimensional Fatigue Inventory (MFI) 4-20

Self reported sleep problems: MOS Sleep Scale 50-0

Self reported disease-specific health-related quality of life: Not assessed


Notes1. Reasons for dropout:

- Treatment Group: 1xmedical complications, 3xpersonal choice

- Control Group: 1x medical complications, 6x personal choice 1x relocation

2. Attendance rate: 89-94% of the patients in the self management education group used at least 1 skill by month

3. Responder analysis: 29% of the patients in the self management education group and 8% of the patients in the TAU group reported a ≥30% pain reduction at final treatment. 31% of the patients in the self management education group and 6% of the patients in the TAU group reported a ≥0.5 SD improvement of the subscale physical functioning of the SF-36 at end of treatment

4. Funding sources and declaration of interest of the primary researchers: Supported in part by Grant numbers R01-AR050044 (NIAMS/ NIH), and DAMD 17-00-2-0018 (Department of Defense).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputerised randomisation program

Allocation concealment (selection bias)Low riskAllocation sequence was done by computerised randomisation

Incomplete outcome data (attrition bias)
All outcomes
Low riskBOCF was used in ITT analysis for missing endpoint values

Selective reporting (reporting bias)Low riskAll outcomes reported

Blinding of outcome assessorLow riskStudy personnel were blinded


MethodsStudy setting: North America (USA). Single university psychology centre, outpatient based; referral by rheumatologists

Study design: Parallel

Duration therapy: 10 weeks

Follow-up: 9 months

Analysis: Comparisons between groups (baseline): t-tests and Chi-quadrat, intention-to-treat approach in all analysis, one-way analysis of co-variances with one fixed-effect was conducted on the primary outcome measure (VAS) at post-treatment, Hedges g. Data were also examined using the perspective of clinical significance (30% improvement)


ParticipantsPatients: Treatment Group: 38 patients, 89% female, 79% white, mean age 48 years

Control Group: 38 patients, 87% female, 74% white, mean age 50 years

Average widespread pain 11.5 years for both groups

Inclusion: ACR 1990 criteria for FM, age 18 to 70 years

Exclusion: pain from traumatic injury or structural or regional rheumatic disease, rheumatoid arthritis, inflammatory arthritis, autoimmune disease, unstable medical or psychiatric illness, active suicidal ideation, a history of psychosis, current psychoactive substance dependence, medication regimen not stable last 2 months. Pregnancy. Participation in psychotherapy


InterventionsTreatment Group: CBT: Individually administered CBT, group: relaxation, activity regulation, facilitation of emotional awareness, cognitive restructuring, interpersonal communication training. Total hours: Not reported

Control Group: Unaugmented TAU

Co-medication allowed: Not reported

Other Co-therapies: Not reported


OutcomesPrimary Outcomes

Self reported pain: VAS pain 0-10

Self reported negative mood: Beck Depression Inventory (BDI) 0-42; Outcomes incompletely reported (non means, only F- and P-values) and not provided on request

Self reported disability: Medical Outcomes Study (MOS) SF-36 Physical Functioning Scale 50-0; Mean extracted from figure; SD not provided on request and calculated by reported P value

Acceptability: Total dropout rate

Secondary Outcomes

Self reported self efficacy pain: Pain-Management Subscale of the Chronic Pain Self Efficacy Scale (CPSE): 10-0 Mean extracted from figure;

Self reported fatigue: Not assessed

Self reported sleep problems: Not assessed

Self reported disease-specific health-related quality of life: Not assessed


Notes1. Reasons for dropout: Not reported for both groups

2. Attendance rate: Not reported

3. Responder analysis: 65.% of the patients in the CBT group and 5.2% of the patients in the TAU group reported a ≥30% pain reduction at end of treatment

4. Funding sources and declaration of interest of the primary researchers: No details reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated random number sequence

Allocation concealment (selection bias)Unclear riskNot reported in detail

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention to-treat analysis. Missing data were imputed by last observation carried forward method

Selective reporting (reporting bias)High riskOutcome depression not reported

Blinding of outcome assessorLow riskStudy personnel masked to participants' treatment condition

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Anderson 2007No randomisation

Carleton 2011Attention modification training in a laboratory; delivery was not from, or supervised by, a healthcare professional qualified in psychology, psychiatry or psychosomatic medicine

De Voogd 2003No randomisation

Garcia 2006Less than 10 patients per treatment arm

Goeppinger 2009Did not meet the criteria of self management. No modelling as supplied by the facilitators

Goldenberg 1994No randomisation

Haugli 2008No separate data of FM-patients presented; not provided on request

Langford 2010Combination of cognitive behavioural therapy with interpersonal (psychodynamic) therapy

Lommel 2011No randomisation

Lorig 2008Details of FM diagnosis not reported

Martinez-Valero 2008< 10 patients per treatment arm

Solomon 2002No separate data of FM patients presented; not provided on request

Stuifbergen 2010Details of FM diagnosis not reported and not provided on request

Van Oosterwijck 2013Pain physiology education without self-management education

Williams 2002Outcomes reported not suited for meta-analysis: 25% of the patients in CBT group and 12% of the patients in the TAU group reported improvement of ≥ 6.5 points on the physical component score of the SF-36. Outcomes suited for meta-analysis not provided on request

 
Characteristics of studies awaiting assessment [ordered by study ID]

MethodsNot yet assessed

Participants43 FM patients

InterventionsCognitive behavioural therapy compared to waiting list control

OutcomesNot yet assessed

NotesNew study


MethodsNot yet assessed

Participants64 FM patients with insomnia

InterventionsCognitive behavioural therapy for insomnia compared to sleep hygiene group

OutcomesNot yet assessed

NotesNew study


MethodsNot yet assessed

Participants26 FM patients

InterventionsCognitive behavioural therapy for insomnia compared to sleep hygiene group

OutcomesNot yet assessed

NotesNew study


MethodsNot yet assessed

Participants40 FM patients

InterventionsAcceptance and commitment therapy

OutcomesNot yet assessed

NotesNew study

 
Comparison 1. Cognitive behavioural therapies versus controls at end of treatment

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pain211453Std. Mean Difference (IV, Random, 95% CI)-0.29 [-0.47, -0.11]

    1.1 Traditional cognitive behavioural therapy
181150Std. Mean Difference (IV, Random, 95% CI)-0.30 [-0.44, -0.15]

    1.2 Operant therapy
2123Std. Mean Difference (IV, Random, 95% CI)-0.67 [-2.56, 1.23]

    1.3 Self-management
2180Std. Mean Difference (IV, Random, 95% CI)0.02 [-0.81, 0.84]

 2 Negative mood191649Std. Mean Difference (IV, Random, 95% CI)-0.33 [-0.49, -0.17]

    2.1 Traditional cognitive-behavioural therapy
151010Std. Mean Difference (IV, Random, 95% CI)-0.34 [-0.48, -0.19]

    2.2 Operant therapy
2124Std. Mean Difference (IV, Random, 95% CI)-0.90 [-2.21, 0.42]

    2.3 Self-management education
3515Std. Mean Difference (IV, Random, 95% CI)-0.10 [-0.27, 0.07]

 3 Disability161234Std. Mean Difference (IV, Random, 95% CI)-0.30 [-0.51, -0.08]

    3.1 Traditional cognitive-behavioural therapy
13931Std. Mean Difference (IV, Random, 95% CI)-0.31 [-0.45, -0.18]

    3.2 Operant therapy
2123Std. Mean Difference (IV, Random, 95% CI)-0.88 [-3.10, 1.33]

    3.3 Self-management education
2180Std. Mean Difference (IV, Random, 95% CI)0.07 [-0.60, 0.74]

 4 Self-efficacy pain111047Std. Mean Difference (IV, Random, 95% CI)-0.49 [-0.80, -0.17]

    4.1 Traditional cognitive-behavioural therapy
9589Std. Mean Difference (IV, Random, 95% CI)-0.39 [-0.72, -0.05]

    4.2 Operant therapy
2123Std. Mean Difference (IV, Random, 95% CI)-1.18 [-3.01, 0.64]

    4.3 Self-management education
1335Std. Mean Difference (IV, Random, 95% CI)-0.18 [-0.39, 0.04]

 5 Acceptability211914Risk Ratio (M-H, Random, 95% CI)0.94 [0.65, 1.35]

    5.1 Traditional cognitive-behavioural therapy
171169Risk Ratio (M-H, Random, 95% CI)0.98 [0.65, 1.46]

    5.2 Operant therapy
2126Risk Ratio (M-H, Random, 95% CI)0.43 [0.03, 7.34]

    5.3 Self-management education
3619Risk Ratio (M-H, Random, 95% CI)1.33 [0.81, 2.19]

 6 Fatigue11910Std. Mean Difference (IV, Random, 95% CI)-0.25 [-0.49, -0.02]

    6.1 Traditional cognitive-behavioural therapy
9667Std. Mean Difference (IV, Random, 95% CI)-0.38 [-0.65, -0.10]

    6.2 Operant therapy
163Std. Mean Difference (IV, Random, 95% CI)0.09 [-0.44, 0.62]

    6.3 Self-management education
2180Std. Mean Difference (IV, Random, 95% CI)0.04 [-0.33, 0.40]

 7 Sleep problems8422Std. Mean Difference (IV, Random, 95% CI)-0.40 [-0.85, 0.05]

    7.1 Traditional cognitive-behavioural therapy
6244Std. Mean Difference (IV, Random, 95% CI)-0.50 [-1.11, 0.11]

    7.2 Operant therapy
160Std. Mean Difference (IV, Random, 95% CI)-0.37 [-0.91, 0.17]

    7.3 Self-management education
1118Std. Mean Difference (IV, Random, 95% CI)0.09 [-0.27, 0.45]

 8 Health-related quality of life131238Std. Mean Difference (IV, Random, 95% CI)-0.23 [-0.38, -0.08]

    8.1 Traditional cognitive-behavioural therapy
11778Std. Mean Difference (IV, Random, 95% CI)-0.34 [-0.49, -0.18]

    8.2 Operant therapy
163Std. Mean Difference (IV, Random, 95% CI)0.19 [-0.34, 0.72]

    8.3 Self-management education
2397Std. Mean Difference (IV, Random, 95% CI)-0.01 [-0.36, 0.33]

 
Comparison 2. Cognitive behavioural therapies versus controls at long-term follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pain14893Std. Mean Difference (IV, Random, 95% CI)-0.40 [-0.62, -0.17]

    1.1 Traditional cognitive-behavioural therapy
13770Std. Mean Difference (IV, Random, 95% CI)-0.28 [-0.43, -0.14]

    1.2 Operant therapy
2123Std. Mean Difference (IV, Random, 95% CI)-1.27 [-2.30, -0.24]

   1.3 Self-management education
00Std. Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 2 Negative mood12792Std. Mean Difference (IV, Random, 95% CI)-0.43 [-0.75, -0.11]

    2.1 Traditional cognitive-behavioural therapy
11669Std. Mean Difference (IV, Random, 95% CI)-0.28 [-0.58, 0.02]

    2.2 Operant therapy
2123Std. Mean Difference (IV, Random, 95% CI)-1.28 [-1.97, -0.59]

   2.3 Self-management education
00Std. Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 3 Disability10735Std. Mean Difference (IV, Random, 95% CI)-0.52 [-0.86, -0.18]

    3.1 Traditional cognitive-behavioural therapy
9612Std. Mean Difference (IV, Random, 95% CI)-0.32 [-0.55, -0.09]

    3.2 Operant therapy
2123Std. Mean Difference (IV, Random, 95% CI)-1.68 [-2.40, -0.96]

   3.3 Self-management education
00Std. Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 4 Self-efficacy pain9617Std. Mean Difference (IV, Random, 95% CI)-0.75 [-1.27, -0.24]

    4.1 Traditional cognitive-behavioural therapy
8494Std. Mean Difference (IV, Random, 95% CI)-0.52 [-1.04, -0.00]

    4.2 Operant therapy
2123Std. Mean Difference (IV, Random, 95% CI)-1.69 [-2.76, -0.62]

   4.3 Self-management education
00Std. Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 5 Fatigue6429Std. Mean Difference (IV, Random, 95% CI)-0.46 [-0.77, -0.15]

    5.1 Traditional cognitive-behavioural therapy
6366Std. Mean Difference (IV, Random, 95% CI)-0.38 [-0.69, -0.07]

    5.2 Operant therapy
163Std. Mean Difference (IV, Random, 95% CI)-1.02 [-1.59, -0.46]

   5.3 Self-management education
00Std. Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 6 Sleep problems7378Std. Mean Difference (IV, Random, 95% CI)-0.64 [-1.31, 0.03]

    6.1 Traditional cognitive-behavioural therapy
6318Std. Mean Difference (IV, Random, 95% CI)-0.46 [-1.11, 0.19]

    6.2 Operant therapy
160Std. Mean Difference (IV, Random, 95% CI)-1.68 [-2.30, -1.06]

   6.3 Self-management education
00Std. Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 7 Health-related quality of life6425Std. Mean Difference (IV, Random, 95% CI)-0.19 [-0.58, 0.21]

    7.1 Traditional cognitive-behavioural therapy
6362Std. Mean Difference (IV, Random, 95% CI)-0.28 [-0.68, 0.11]

    7.2 Operant therapy
163Std. Mean Difference (IV, Random, 95% CI)0.39 [-0.15, 0.92]

   7.3 Self-management education
00Std. Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 
Summary of findings for the main comparison.

Cognitive behavioural therapies compared to controls for fibromyalgia

Patient or population: Patients with fibromyalgia

Settings: In- and outpatient

Intervention: Cognitive behavioural therapies

Comparison: Controls (attention control, treatment as usual, waiting list, other active therapy)

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

controlsCognitive behavioural therapies

Pain

end of treatment

(0-10 scale)

Higher scores indicate higher pain levels
Mean pain baseline

7.37 (SD 2.10) 3
The mean pain in the intervention groups was 0.29 standard deviations lower (0.49 to 0.11 lower)1382
(20)
⊕⊕⊝⊝
low1,2
SMD -0.29 (95% CI -0.47 to -0.11)

8.5% (95% CI 3.1% to 14.0%) relative improvement

6.3 % (95% 2.3% to 10.3%) CI) fewer points on the scale (absolute change)

NNTB 7 (95% CI 5 to19)

Pain
follow-up median 6 months

(0-10 scale)

Higher scores indicate higher pain levels
Mean pain baseline

64.72 (SD 10.44) 4
The mean pain in the intervention groups was 0.40 standard deviations lower (0.64 to 0.16 lower)822
(14)
⊕⊕⊝⊝
low 1,2
SMD -0.40 (95% CI -0.62 to -0.17)

6.4% (95% CI 2.7% to 9.9%) relative improvement

4.2% (95% CI 1.8% to 6.5%) fewer points on the scale (absolute change)

NNTB 10 (95% CI 6 to 24)

Negative mood

end of treatment

(0-10 scale)

Higher scores indicate higher negative mood levels
Mean depression

baseline 6.82 (SD 3.11) 5
The mean negative mood in the intervention groups was 0.33 standard deviations lower (0.49 to 0.17 lower)1578
(18)
⊕⊕⊝⊝
low1,2
SMD -0.33 (95% CI -0.49 to -0.17)

15.0% (95% CI 7.7% to 22.3%) relative improvement

10.2% (95% CI 5.2% to 15.2%) fewer points on the scale (absolute change)

NNTB 6 (95% CI 4 to12)

Negative mood
follow-up median 6 months

(0-50 scale)

Higher scores indicate higher negative mood levels
Mean depression

baseline 14.94 (SD 3.11) 6
The mean negative mood in the intervention groups was 0.43 standard deviations lower (0.75 to 0.11 lower)721
(11)
⊕⊕⊝⊝
low 1,2
SMD -0.43 (95% CI -0.75 to -0.11)

8.9% (95% CI 2.3% to 15.8%) relative improvement

2.7% (95% CI 0.1% to 4.7%) fewer points on the scale (absolute change)

NNTB 11 (95% CI 6 to 43)

Disability

end of treatment

(0-10 scale)

Higher scores indicate disability levels
Mean physical impairment baseline 2.80 (SD 2.40) 7The mean disability in the intervention groups was 0.30 standard deviations lower (0.51 to 0.08 lower)1163
(15)
⊕⊕⊝⊝
low1,2
SMD -0.30 (95% CI -0.51 to -0.08)

25.8 % (95% CI 6.9% to 43.7% relative improvement

7.2% (95% CI 1.9% to 12.2%) fewer points on the scale (absolute change)

NNTB 7 (95% CI 4 to 26)

Disability
follow-up median 6 months

(0-10 scale)

Higher scores indicate disability levels
Mean physical impairment baseline 3.24 (SD 2.26) 8The mean disability in the intervention groups was 0.52 standard deviations lower (0.86 to 0.18 lower)664
(9)
⊕⊕⊝⊝
low1,2
SMD -0.52 (95% CI -0.86 to -0.18)

36.4% (95% CI 1.3% to 60.2%) relative improvement

11.7% (95% CI 4.1% to 19.4%) fewer points on the scale (absolute change)

NNTB 4 (95% CI 3 to12)

Acceptability

end of treatment (dropouts from study due to any reasons)
136 (94 to 195) per 1000127 (88 to 182)RR 0.94 (0.65 to 1.35)1914 (21)⊕⊕⊝⊝
low 1
Absolute risk difference
0% (95% CI -1 to 0)

Relative per cent change
6% (95% CI 15%
improvement to 35%
worsening)

Not statistically significant

*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% 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

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 Some studies with lack of reported allocation concealment, without intention-to-treat analysis and with selective outcome reporting
2 High heterogeneity of treatment effect
3 Luciano 2011: N=216 patients; Pain VAS 0-10 scale
4 Alda 2011: N=113 patients; Pain VAS 0-100 scale
5 Luciano 2011: N=216 patients; Depression VAS 0-10 scale
6 Alda 2011; N=113 patients; Hamilton Rating Scale for Depression (0-50)
7 Luciano 2011: N=216 patients; Physical impairment VAS 0-10 scale
8 Alda 2011; N=113 patients; Physical impairment VAS 0-10 scale
 
Summary of findings 2. Cognitive behavioural therapies versus controls for fibromyalgia

Cognitive behavioural therapies versus controls for fibromyalgia

Patient or population: Patients with fibromyalgia

Settings: In- and outpatients

Intervention: Cognitive behavioural therapies

Comparison: Controls (attention control, treatment as usual, waiting list, other active therapy)

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlCognitive behavioural therapies versus controls final treatment

Fatigue

end of treatment

(0-10 scale)

Higher scores indicate higher fatigue levels
Mean fatigue score 8.13 (SD 1.89) 3The mean fatigue in the intervention groups was
0.25 standard deviations lower
(0.49 to 0.02 lower)
910
(11 studies)
⊕⊕⊝⊝
low1
SMD -0.25 (95% CI -0.49 to -0.02)

5.8% (95% CI 0.05% to 11.3%) relative improvement

4.7% (95% CI 0.4% to 9.3%) fewer points on the scale (absolute change)

NNTB 9 (95% CI 5 to109)

Sleep problems

end of treatment

(0-50 scale)

Higher scores indicate more sleep problems
Mean sleep problems score 27.9 (SD 8.8) 4The mean sleep problems in the intervention groups was
0.4 standard deviations lower
(0.85 lower to 0.05 higher)
422
(8 studies)
⊕⊕⊝⊝
low2
SMD -0.40 (95% CI -0.85 to 0.05)

0.3% (95% CI -0.03% to 1.7%) relative improvement

7.0% (95% CI -0.90% to 15.0%) fewer points on the scale (absolute change)

NNTB 5 (95% CI -45 to 3)

Health-related

quality of life

end of treatment

(0-80 scale)

Higher scores indicate lower health-related quality of life
Mean health-related quality of life score 55.97 (SD 15.95) 5The mean health-related quality of life in the intervention groups was
0.23 standard deviations lower
(0.38 to 0.08 lower)
1238
(13 studies)
⊕⊕⊝⊝
low1,2
SMD -0.23 (95% CI -0.38 to -0.08)

0.08% (95% CI 0.03% to 0.13%) relative improvement

4.6% (95% CI 1.6% to 7.6%) fewer points on the scale (absolute change)

NNTB 9 (95% CI 6 to 27)

Fatigue

Follow-up median 6 months

(0-10 scale)

Higher scores indicate higher fatigue levels
Mean fatigue score

Mean 8.32 (SD 2.17)6
The mean fatigue in the intervention groups was
0.46 standard deviations lower
(0.77 to 0.15 lower)
429
(6 studies)
⊕⊕⊝⊝
low1,2
SMD -0.46 (95% CI -0.77 to -0.15)

1.2% (95% CI 0.4% to 2.0%) relative improvement

10.0% (95% CI 3.2% to 16.7%) fewer points on the scale (absolute change)

NNTB 5 (95% CI 3 to 14)

Sleep problems
Follow-up median 6 months

(0-50 scale)

Higher scores indicate more sleep problems
Mean sleep problems score 27.9 (SD 8.8) 4The mean sleep problems in the intervention groups was
0.64 standard deviations lower
(1.31 lower to 0.03 higher)
378
(7 studies)
⊕⊕⊝⊝
low1,2
SMD -0.64 (95% CI -1.31 to 0.03)

0.4% (95% CI -0.02% to 0.8%) relative improvement

11.2% (95% CI -0.53% to 23.1%) fewer points on the scale (absolute change)

NNTB 4 (95% CI -74 to 2)

Health-related

quality of life

Follow-up median 6 months

(0-80 scale)

Higher scores indicate lower health-related quality of life
Mean health-related quality if life score 64.48

(SD 10.50) 7
The mean health-related quality of life in the intervention groups was
0.19 standard deviations lower
(0.58 lower to 0.21 higher)
425
(6 studies)
⊕⊕⊝⊝
low1
SMD -0.19 (95% CI -0.58 to 0.21)

0.03% (95% CI -0.03% to 0.15%) relative improvement

2.0% (95% CI -2.2% to 6.1%) fewer points on the scale (absolute change)

NNTB 12 (95% CI -17 to 6)

Acceptability
Follow-up: median 6 months
See commentSee commentNot estimable-See commentNot assessed

*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% 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; 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 Some studies with lack of reported allocation concealment, without intention-to-treat analysis and with selective reporting
2 High heterogeneity of treatment effect
3 Luciano 2011: N=216 patients; VAS 0-10 scale
4 Castel 2012; N=60 patients; NRS 0-50 scale
5 Luciano 2011: N=216 patients; VAS 0-80 scale
6 Alda 2010; N= 113; VAS 0-10 scale
7 Alda 2010; N= 113; VAS 0-100 scale
 
Table 1. Main characteristics of included studies

AuthorCountryType of CBTType of control groupDuration CBT (weeks)Number of CBT sessions

Total treatment time CBT (hours)
Number of patients in CBT group

% women
Number of patients in control group

% women

Alda 2011 *SpainCBTTAU126

15
57

95
56

96

Ang 2010 *USACBTTAU126

3
17

100
15

100

Burckhardt 1994 *SwedenCBTDelayed treatment66

9
28

100
30

100

Castel 2009 *SpainCBTTAU1112

18
18

94
12

86

Castel 2012 *SpainCBTTAU1414

28
34

94
30

100

Edinger 2005 *USACBTTAU66

6
16

94
12

100

Falcao 2008 *BrazilCBTTAU1020

30
30

100
30

100

Kashikar-Zuck 2005 **USACBTActive control88

12
14

100
14

100

Kashikar-Zuck 2012 **USACBTActive control88

6
57

95
57

90

King 2002 *USACBTDelayed treatment1212

18
48

100
39

100

Luciano 2011 *SpainCBTTAU88

16
108

95
108

98

Miro 2011 *SpainCBTActive control66

9
20

100
20

100

Nicassio 1997 *USACBTActive control1010

15
36

89
35

89

Oliver 2002 *USASelf-managementTAU5210

20
207

96
193

94

Redondo 2004 *SpainCBTActive control88

20
21

100
19

100

Rooks 2007 *USASelf-managementActive control168

16
51

100
50

100

Soares 2002 *SwedenCBTAttention control1010

120
18

100
18

100

Thieme 2003 *GermanyOperant therapyActive control525

75
42

100
21

100

Thieme 2006a *GermanyOperant therapyAttention control1515

30
42

100
20

100

Thieme 2006b *GermanyCBTAttention control1515

30
43

100
20

100

Vlayen 1996 *NetherlandsCBTActive control612

18
49

93
43

82

Wigers 1996 *NorwayCBTTAU1415

30
20

90
20

95

Williams 2010 *USASelf-managementTAU26NR59

95
59

95

Woolfolk 2012 *USACBTTAUNRNR38

89
38

87

 * Studies included only adults  
** Studies included only children and adolescents
NR = Not reported and not provided on request
TAU = Treatment as usual
 
Table 2. Reported treatment quality

 Treatment content and settingTreatment durationManualisationAdherence to manualTherapist trainingClient engagementSum

Alda 20112121107

Ang 20102121208

Burckhardt 19941100103

Castel 20091100002

Castel 20121121016

Edinger 20051120105

Falcao 200811001

 
14

Kashikar-Zuck 20052121219

Kashikar-Zuck 20122121219

King 20021100013

Luciano 20112110105

Miro 20112120106

Nicassio 19971100002

Oliver 20022100003

Redondo 20042100003

Rooks 20072100003

Soares 20021100103

Thieme 20032120005

Thieme 20062110206

Vlayen 19961100002

Wigers 19961100114

Williams 20102110116

Woolfolk 20121120004

 Items and scores of treatment quality scale (Yates 2005)
1. Treatment content and setting: 2 - Adequate: a clear rationale for the treatment has been reported along with an adequate description of its content; 1 - Partial: either a clear rationale or a description of the content of the treatment is reported; 0 - Inadequate:neither the rationale for treatment or the treatment content are adequately reported.
2. Treatment duration: 1 – Reported; 0 - Unknown.
3. Manualistion of treatment: 2 - Adequate: there is reference to use of a manual that describes the active components of the treatment of study. If more than one treatment arm, manuals were used for all the appropriate treatments; 1 - Partial:in trials with more than one treatment arm, the use of a manual is described but not for all the treatments that would be expected to be manualised; 0 - Inadequate: no evidence that a manual has been used, but reference is made to various principles.
4. Adherence to the manual: 1 - Adequate: there is evidence that the investigators have checked adherence to the manual during the period of study via direct observations, tape recording or supervisory processes that explicitly state adherence to the manual; 0 - Inadequate: no evidence of adherence checks reported.
5. Therapist training: 2 - Adequate: there is documentation of explicit training for the treatment of the trial; 1 - Partial: the general level of therapist training is reported and is adequate (professionally qualified) but there is no mention of explicit training for the trial; 0 - Inadequate: there is no convincing evidence that the therapists have an adequate level of training (e.g. graduate level) or explicit training for the trial.
6. Client Engagement: 1 - Adequate: documented that evidence of engagement was sought e.g. checks on homework were made, skills practice in sessions; 0 – inadequate: no evidence that checks were made on level of engagement.