Van Koulil 2010.
| Methods | RCT; 2 arms; CBT: WLC; post‐treatment: 6‐month follow‐up | |
| Participants | End of treatment: n = 152 Start of treatment: n = 158 Sex: 148 F, 10 M Mean age: 40.8 (SD 10.5) Mean years of pain: not given (< 5 years since diagnosis) Source = rheumatology clinics Diagnosis = fibromyalgia |
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| Interventions | Tailored CBT with exercise training; waiting list control | |
| Outcomes |
Primary pain outcome: Pain IRGL Primary disability outcome: Mobility IRGL Primary mood outcome: Negative mood IRGL Catastrophising outcome: none Pain: 6 items of IRGL Disability: 7 mobility items of IRGL (reversed) Impact: Fibromyalgia Impact Questionnaire Negative mood: 6 items of IRGL Anxiety: 10 items of IRGL |
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| Notes | CBT versus WLC: analyses 3.1, 3.2, 3.3, 4.1, 4.2, 4.3 2011 update search Yates quality scale: total quality 24/35, design quality 15/26, treatment quality 9/9 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | “randomized in clusters” |
| Allocation concealment (selection bias) | High risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition reported; 2 differences between dropouts and completers |
| Selective reporting (reporting bias) | Low risk | Fully reported |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not reported |