Characteristics of studies with cognitive-behavioral therapies in fibromyalgia syndrome (FM). Studies are arranged in alphabetical order by author.
| Study; Setting; Referral | Mean age, yrs; Women, Race | Exclusion Criteria | Diagnosis of FM; Comorbidities Assessed and Reported | Population | Treatment Group | Control Group | Outcomes Usable for Metaanalysis; Latest Followup | |||
|---|---|---|---|---|---|---|---|---|---|---|
| N Screened Randomized (%) | N Completing End of Therapy (%) | N Completing End of Therapy (%) | Treatment (duration) | Treatment (duration) N Completing End of Therapy (%) | Comedication Allowed; Other Cotherapies; Attendance Rates (all sessions); Side effects | |||||
| Astin USA 2003: university outpatient based; radio/newspaper advertisement and local physicians | 48; 99% women, 91% White | Internal disease, major mental disorder, pending litigation | ACR; Yes | NR | 128/65 (51) | 64/32 (50) | Cognitive (MBSR) group: mindfulness meditation (1 × 1.5 h/8 wks) plus Qi-gong (1 × 1 h/8 wks) Total: 20 h | Attention control: education and support; (8 × 2.5 h) Total 20 h 63/33 (51) | NR NR IR NR | Pain SF-36 Pain Sleep NP Fatigue NP Depression BDI total HRQOL FIQ total SE Pain CSQ NP HCSB NA; 6 mo |
| Burckhardt Sweden 1994; regional hospital outpatient based; Clinic register | 46.5; 100% women, 99% White | Rheumatic disease | ACR; no | 120/99 (83) | 99/86 (87) | 31/28 (90) | CBT group: education, relaxation, assertiveness training, coping strategies, problem solving techniques (1 × 1.5 h/6 wks) Total 9 h | Delayed treatment control — 35/30 (86) Study arm CBT plus physical therapy not used for comparison | Yes, not controlled for NR NR NR | Pain VAS 0–10* Sleep VAS 0–10 NA Fatigue VAS 0–10* Depression 0–10* HRQOL FIQ total* SE Pain SES NP HCSB NA; 3 and 6 mo but not control group |
| Edinger USA 2005; university outpatient based; newspaper advertisement | 48.6; 92% women, 90% White | Somatic diseases associated with sleep disorder, mental disorder except dysthymia | ACR; Yes | 106/47 (44) | 47/41 (87) | 16/15 (94) | CBT group: insomnia therapy with education and stimulus control (1 × 1 h/6 wks) Total 6 h | Usual care — 11/9 (82) Treatment arm sleep hygiene not used for comparison | Yes NR IR NR | Pain: MPQ total Sleep: ISQ total Fatigue NA Depression NA HRQOL NA SE Pain NA HCSB NA; 6 mo |
| Garcia Spain 2006; university outpatient based; pain and rheumatology department | 49.9; 96% women, NR | No medication, request or lawsuit for disability | ACR, No | NR | 28/28 (100) | 7/7 (100) | CBT group: Education, relaxation, cognitive techniques, self-instructions (1 × 1.5 h/9 wks) Total 13.5 h | Nontreatment 7/7 (100) Treatment arms pharmacological therapy and pharmacological therapy plus CBT not used for comparison | No medication used for FM NR NR NR | Pain NP Sleep NP Fatigue NP Depression NP HRQOL: FIQ total SE Pain NA HCSB NA; 3 mo |
| Grossman Switzerland 2007; university outpatient based; local physician; self-help group | 54.4; 100% women, NR | Life-threatening disease, mental disorder that could interfere with adherence | ACR; 26% suggestive of a mental disorder | NR | 58/52 (90) | 43/39 (91) | Cognitive (MBSR) group: formal mindfulness practice, mindful awareness during yoga, stressful situations and social interactions (1 × 2.5 h/8 wks plus one day) Total 27 h | Attention control group: nonspecific elements of MBSR: progressive relaxation, gentle stretching, group discussion (8 wks, 27 h) 15/13 (87) | NR NR IR NR | Pain VAS 0–100 Sleep NA Fatigue NA Depression HADS HRQOL QoL** SE Pain IPR HCSB NA; 36 mo, but not control group |
| Kashikar-Zuck USA 2005; university outpatient based; pediatric rheumatology clinic | 15.8; 100% women, 93% White | Rheumatic disease, depressive disorder | JPFM; No | 44/30 (68) | 30/27 (90) | 15/14 (93) | CBT single. Group and with parents: relaxation, distraction; activity pacing, cognitive and problem-solving techniques (1 × 1.5 h/8 wks) Total 12 h | Active control; Single: self-monitoring with diary 15/13 (87) | NR NR 90% NR | Pain VAS 0–10 Sleep NA Fatigue NA Depression CDI HRQOL NA SE Pain PCQ HCSB NA; No followup |
| Nicassio USA 1997; university outpatient-based; community, private and hospital rheumatologists, FMS support groups | 53.1; 89% women, 86% White | Rheumatic disease, other serious illness, psychosis or bipolar disorder | ACR; No | 94/86 (92) | 86/71 (82) | 48/36 (75) | CBT group: education, relaxation, activity pacing, pain coping, involvement of support person reinforcing adherence to protocol (1 × 1.5 h/10 wks) Total 15 h | Attention control, Group: lectures, group discussion, support (10 wks, 1.5 h/wk) Total 15 h 38/35 (92) | Yes, not controlled for NR NR NR | Pain Index Sleep NA Fatigue NA Depression CES-D HRQOL QWB SE Pain RAI HCSB NA; 6 mo |
| Redondo Spain 2004; university general practitioners | NR; 100% women, NR | Serious concomitant diseases | ACR; No | 56/40 (71) | 40/31 (77) | 21/16 (76) | CBT group: education, relaxation, coping with pain and daily activities, problem solving, prevention of relapses (1 × 2.5 h/8 wks) Total 20 h | Active control: pool and cycle ergometer (5 × wk 0.45 h; 8 wks) Total 30 h 19/15 (79) | Flexible medication with NSAID, amitriptyline and acetaminophen allowed NR 72% NR | Pain VAS 0–10 Fatigue VAS 0–10 Sleep VAS 0–10 Depression BDI total HRQOL FIQ total SE Pain CPSS HCSB NA; 12 mo |
| Sephton USA 2007; university outpatient based; television broadcast and newspaper advertisement | 48; 100% women, 94% White | Severe mental illness | ACR; Yes | 282/91 (32) | 91/78 (86) | 51/41 (80) | Cognitive (MBSR) group: stress reduction by sitting meditation, hatha yoga and body scan; meditation retreat (1 × 2.5 h/8 wks plus one day; daily home practice of 30–45min encouraged) Total 28 h | Delayed treatment control 40/27 (68) | Flexible comedication allowed NR 69% NR | Pain NA Sleep NA Fatigue NA Depression BDI total HRQOL NA SE Pain NA HCSB NA; 2 mo |
| Soares Sweden 2002; university outpatient based; practitioners | 45; 100% women, NR | Serious somatic diseases, substance abuse, other therapies | ACR; No | 85/53 (62) | 60/53 (88) | 20/18 (90) | CBT single and group: education, problem solving, pain- and self-management [10 wks (2x2 h individual, 15 × 2 h group)] Total 34 h | Attention control, Group: education, discussion (10 wks, total 102 h) 20/18 (90) Waiting list control not used for comparison because of lack of followup assessment | No other therapy No other therapy NR NR | Pain MPQ total Sleep KSQ Sleep Quality Fatigue NA Depression NA HRQOL FIQ total SE Pain ASES Pain HCSB NA; 6 mo |
| Thieme Germany 2003; inpatient-based; district hospital, district hospital for rheumatic diseases | 46.6; 100% women, NR | Serious somatic diseases, major psychiatric disorder | ACR; No | NR | 61/61 (100) | 40/40 (100) | Behavior group: education; structured time-contingent exercises, reduction of medication, increase of bodily activity, reduction of interference of pain with daily activities; reduction of healthcare utilization; assertiveness training 5 wks DNR Total 75 h | Active control: Group: education, antidepressants, passive physical therapy 21/21 (100) (5 wks, 5 days a wk) Total 75 h | Reduction of medication NR NR NR | Pain MPI 0–6 Sleep NA Fatigue NA Depression NA HRQOL MPI Total Activity Scale SE Pain MPI HCSB, number of physician visits; 15 mo |
| Thieme Germany 2006; university outpatient based; rheumatology clinics | 45; 100% women, NR | Serious somatic diseases | ACR; NR | 131/125 (95) | 125/100 (80) | OBT 43/40 (93) CBT 42/40 (95) | Behavior group: education; structured time-contingent exercises; reduction of medication, increase of bodily activity, reduction of interference of pain with daily activities; reduction of healthcare utilization; assertiveness training CBT group: relaxation, problem-solving, stress and pain coping (Both groups: 1 × 2 h/15 wks) Total 30 h | Attention control, Group: discussion (h NR) 40/20 (50) | NR NR NR 2 dropouts because of depression in behavior and CBT each | Pain VAS 0–10** Sleep NA Fatigue VAS 0–10** Depression VAS 0–10** HRQOL FIQ total SE Pain PRSS** HCSB, number of physician visits; 12 mo |
| Vlaeyen Netherlands 1996; university outpatient based; regional general hospital | 44; 88% women, NR | Somatic diseases, substance abuse, disability litigation | ACR; No | 290/131 (45) | 125/112 (90) | 49/39 (80) | CBT group: education (24 h), imagination, EMG-supported relaxation; training to use relaxation skills in case of stimuli of muscle tension (1 × 2 h/12 wks) Total 48 h | Active control: group education and low intensity physical exercise (12 wks, 2 h) Total 24 h 39/30 (77) Waiting list control not used for comparison because of lack of followup assessment | NR NR 78% 1 dropout in CBT and 2 in control because of increase of symptoms | Pain Index Sleep NA Fatigue NA Depression BDI HRQOL*** SE Pain CSQ HCSB***; 12 mo |
| Wigers Norway 1996; university outpatient; local patient association and outpatient department | 43; 90% women, NR | NR | ACR; NR | 76/60 (79) | 60/48 (80) | 20/16 (80) | CBT group: relaxation, stress management skills (1 × 1–1.5 h/14 wks) Total 21 h | Usual care — 20/17 (85) Study arm aerobic from exercise not used for comparison | Baseline treatment unchanged Exclusion analysis if new therapies were initiated IR No treatment related side effects | Pain VAS 0–100 Fatigue VAS 0–100 Sleep VAS 0–100 Depression VAS 0–100 HRQOL NA SE Pain NA HCSB NA; 48 mo |
↵* SD substituted by the mean of SD of other trials on the same scale;
↵** data provided on request;
↵*** HRQOL utilities as reported32 not suited for metaanalysis: HCSB-data as reported32. Reasons for exclusion from metaanalysis: see Discussion. ACR: American College of Rheumatology; ASES: Arthritis Self-Efficacy Scale; BDI: Beck Depression Inventory; CBT: cognitive-behavioral therapy; CDI: Children’s Depression Inventory; CES-D: Center for Epidemiological Studies Depression Scale; CSQ: Coping Strategies Questionnaire; DNR: details not reported; EMG: electromyography; FIQ: Fibromyalgia Impact Questionnaire; HADS: Hospital Anxiety and Depression Scale; HRQOL: health-related quality of life; HCSB: healthcare-seeking behavior; IPR: Inventory of Pain Regulation; IR: insufficiently reported; ISQ: Insomnia Symptom Questionnaire; JPMF: juvenile primary fibromyalgia; MMQ: Mild Motion Questionnaire; MPI: Multidimensional Pain Inventory; MPQ: McGill Pain Questionnaire; NA: not assessed; NP: not provided on request; NR: not reported; OBT: operant behavioral therapy; PCQ: Pain Coping Questionnaire; PRSS: Pain-related self-statement scale; QoL: Quality of life profile for the Chronically Ill; RAI: Rheumatology Attitude Index, subscale helplessness; SCL 90-R: Symptom Check List 90-revised; SE: self-efficacy; SES: Self-Efficacy Scale; SF-36: Short Form Health Survey; VAS: visual analog scale.