Woolfolk 2012.
| Methods |
Study setting: North America (USA). Single university psychology centre, outpatient based; referral by rheumatologists Study design: Parallel Duration therapy: 10 weeks Follow‐up: 9 months Analysis: Comparisons between groups (baseline): t‐tests and Chi‐quadrat, intention‐to‐treat approach in all analysis, one‐way analysis of co‐variances with one fixed‐effect was conducted on the primary outcome measure (VAS) at post‐treatment, Hedges g. Data were also examined using the perspective of clinical significance (30% improvement) |
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| Participants |
Patients: Treatment Group: 38 patients, 89% female, 79% white, mean age 48 years Control Group: 38 patients, 87% female, 74% white, mean age 50 years Average widespread pain 11.5 years for both groups Inclusion: ACR 1990 criteria for FM, age 18 to 70 years Exclusion: pain from traumatic injury or structural or regional rheumatic disease, rheumatoid arthritis, inflammatory arthritis, autoimmune disease, unstable medical or psychiatric illness, active suicidal ideation, a history of psychosis, current psychoactive substance dependence, medication regimen not stable last 2 months. Pregnancy. Participation in psychotherapy |
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| Interventions |
Treatment Group: CBT: Individually administered CBT, group: relaxation, activity regulation, facilitation of emotional awareness, cognitive restructuring, interpersonal communication training. Total hours: Not reported Control Group: Unaugmented TAU Co‐medication allowed: Not reported Other Co‐therapies: Not reported |
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| Outcomes |
Primary Outcomes Self reported pain: VAS pain 0‐10 Self reported negative mood: Beck Depression Inventory (BDI) 0‐42; Outcomes incompletely reported (non means, only F‐ and P‐values) and not provided on request Self reported disability: Medical Outcomes Study (MOS) SF‐36 Physical Functioning Scale 50‐0; Mean extracted from figure; SD not provided on request and calculated by reported P value Acceptability: Total dropout rate Secondary Outcomes Self reported self efficacy pain: Pain‐Management Subscale of the Chronic Pain Self Efficacy Scale (CPSE): 10‐0 Mean extracted from figure; Self reported fatigue: Not assessed Self reported sleep problems: Not assessed Self reported disease‐specific health‐related quality of life: Not assessed |
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| Notes | 1. Reasons for dropout: Not reported for both groups 2. Attendance rate: Not reported 3. Responder analysis: 65.% of the patients in the CBT group and 5.2% of the patients in the TAU group reported a ≥30% pain reduction at end of treatment 4. Funding sources and declaration of interest of the primary researchers: No details reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated random number sequence |
| Allocation concealment (selection bias) | Unclear risk | Not reported in detail |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention to‐treat analysis. Missing data were imputed by last observation carried forward method |
| Selective reporting (reporting bias) | High risk | Outcome depression not reported |
| Blinding of outcome assessor | Low risk | Study personnel masked to participants' treatment condition |