Nicassio 1997.
Methods | RCT; 2 arms; assessed at pre‐treatment, post‐treatment, 6 months | |
Participants | End of treatment n = 71 Start of treatment n = 96 Sex: 63 F, 8 M (at follow‐up) Mean age = 53.1 (SD no given) Source = pain or rehabilitation clinic, support groups Diagnosis = fibromyalgia Mean years of pain = 11.1 |
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Interventions | "behavioural treatment" "education" |
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Outcomes |
Primary pain outcome: not available Primary disability outcome: quality of well being Primary mood outcome: CES‐D Depression Catastrophising outcome: RAI helplessness Pain index: composite of Fibromyalgia Impact Questionnaire pain scale, MPQ PRI, number of body areas, and flare index Pain Behavior Checklist self reported pain behaviour Pain behaviour (Keefe & Block) observation Center for Epidemiologic Studies Depression Scale (CES‐D) Rheumatology Attitudes Index helplessness subscale Pain Management Inventory active and passive coping Quality of Well being Scale QWB: structured interview on functional impairment Quality of Social Support Scale Myalgia score, nurse rated on examination |
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Notes | BT versus active, post‐treatment and follow‐up: analyses 5.2, 5.3, 6.2, 6.3 Yates quality scale: total quality = 21/35, design quality = 15/26, treatment quality = 6/9 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | In blocks, “randomly assigned, using a random numbers table” |
Allocation concealment (selection bias) | High risk | Not reported, though credibility ratings equal across treatments |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition fully reported; differential attrition across groups; no differences |
Selective reporting (reporting bias) | Low risk | Fully reported |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not reported |