Thieme 2006.

Methods	Study 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
Participants	Patients: 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)
Interventions	Treatment 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
Outcomes	Primary 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
Notes	1. 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
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No detailed information
Allocation concealment (selection bias)	Unclear risk	No detailed information
Incomplete outcome data (attrition bias) All outcomes	Low risk	Intention‐to‐treat analysis by last observation carried forward method
Selective reporting (reporting bias)	Low risk	All outcomes reported or provided on request
Blinding of outcome assessor	Unclear risk	No detailed information