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 |
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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 |
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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 |
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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 |
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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 |
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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 |