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+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 (−615.13 to 287.81) from the health care perspective, and €−197.32 (−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