Castel 2012.
| Methods |
Study setting: Europe (Spain). Single centre, recruitment in university pain clinic, outpatient based Study design: Parallel Duration therapy: 14 weeks Follow‐up: 3 and 6 months Analysis: T‐tests with Bonferroni correction. Linear mixed model analysis (interaction between time and group) for outcome measures |
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| Participants |
Patients: Treatment Group: 34 patients, 94% female, race not reported, mean age 50 years; pain duration 13.6 (9.2) years Control Group: 30 patients, 100% female, race not reported, mean age 48.7 years; pain duration 11.6 (6.9) years Inclusion: ACR 1990 criteria for FM, age between 18 years and less than 65 years Exclusion: One or more additional severe chronic medical pain conditions, significant suicidal ideation, severe psychopathology (e.g. psychosis), moderate to severe cognitive impairment |
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| Interventions |
Treatment Group: CBT, group (except session 2):Education on FMS and pain perception theory (Session 1, autogenic training (session 2), cognitive restructuring training (sessions 3‐5), cognitive behavioural training for primary insomnia (sessions 6‐8), assertiveness training (sessions 9‐10), activity pacing and pleasant activity scheduling training (sessions 11‐12), behavioral goal setting (session 13), life values and relapse training (session 14); audio CD of autogenic training to practice at home;1 session/week for 4 weeks (2h/week), total:28h Control Group: TAU: Pharmacological treatment including analgesics, antidepressants, anticonvulsants and myorelaxants, as appropriate Co‐medication allowed: Standard medication management Other Co‐therapies: Not reported |
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| Outcomes |
Primary Outcomes Self reported pain: Numeric rating scale 0‐10 Self reported negative mood: Hospital Anxiety and Depression Scale (HADS) total score 0‐42 Self reported disability: FIQ physical impairment 0‐10: Data provided on request Acceptability: Total dropout rate Secondary Outcomes Self reported self efficacy pain: Not assessed Self reported fatigue: FIQ Fatigue 0‐10; Data provided on request Self reported sleep problems: SF‐36 sleep problems index 50‐0 Self reported disease‐specific health‐related quality of life: FIQ total score 0‐100 |
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| Notes | 1. Treatment arm CBT plus hypnosis not used for comparison 2. Reasons for dropout: Not reported 3. Attendance rates: Patients in CBT groups attended a mean of 12.3 (SD 1.7) sessions 4. Responder analysis: 8.8% of the patients in the CBT group reported a ≥30% pain reduction at final treatment and 17.6% at six months follow‐up. 16.7 % of the patients in the TAU group reported a ≥30% pain reduction at final treatment and 13.3% at six months follow‐up. 55.9% of the patients in the CBT group reported a ≥14% reduction of the FIQ total score at final treatment and 58.8% at six months follow‐up. 23.3% of the patients in the TAU group reported a ≥14% reduction in the FIQ total score at final treatment and 20% at six months follow‐up. 5. 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) | Unclear risk | No details reported |
| Allocation concealment (selection bias) | Unclear risk | No details reported |
| 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 | Low risk | Psychologist blinded to participants' group assignment |