OBJECTIVE: To determine the effectiveness of adding psychoeducational treatment implemented in general practice to usual care for patients with fibromyalgia (FM), and to analyze the cost-utility of the intervention from health care and societal perspectives. METHODS: Twelve-month randomized controlled trial. A total of 216 primary care patients meeting the American College of Rheumatology criteria for FM participated in the study. The intervention included 9, 2-hour sessions of psychoeducation (5 sessions of education about the illness plus 4 sessions of autogenic relaxation) added to usual care provided by a multidisciplinary group in general practice was compared to usual care in the public health system. RESULTS: At 12-month follow-up, patients who received psychoeducation showed greater improvement in global functional status (Cohen d = 0.36; -2.49 to 3.81), physical functioning (Cohen d = 0.56; 0.08 to 1.00), days feeling well (Cohen d = 0.40; -0.16 to 1.02), pain (Cohen d = 0.35; -0.04 to 0.80), morning fatigue (Cohen d = 0.24; -0.20 to 0.76), stiffness (Cohen d = 0.34; -0.10 to 0.87), and depression (Cohen d = 0.30; -0.26 to 0.93). Mean incremental cost per person receiving the intervention was -215.49 Euro (-615.13 to 287.81) from the health care perspective, and -197.32 Euro (-785.12 to 395.74) from the societal perspective. The incremental gain in quality-adjusted life-years per person was 0.12 (0.06 to 0.19), yielding a "dominant" intervention from both perspectives. The sensitivity analysis suggested that the intervention was cost-effective even imputing all missing data. DISCUSSION: Our findings demonstrate the long-term clinical effectiveness of a psychoeducational treatment program for FM implemented at primary care level and the cost-utility from a health care and societal perspective. TRIAL REGISTRATION: NCT00550966.

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