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. 2013 Sep 10;2013(9):CD009796. doi: 10.1002/14651858.CD009796.pub2

Wigers 1996.

Methods Study 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
Participants Patients: 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
Interventions Treatment 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
Outcomes Primary 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
Notes 1. 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
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization by drawing lots
Allocation concealment (selection bias) Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk ITT
Selective reporting (reporting bias) Low risk All outcomes reported
Blinding of outcome assessor Unclear risk No details reported