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
*Research and Development Unit, Parc Sanitari Sant Joan de Déu., Sant Boi del Llobregat, Barcelona
§Primary Health Centre Bartomeu Fabrés Anglada, DAP Baix Llobregat Litoral, Unitat Docent Costa de Ponent, Institut Català de la Salut., Gavà
∥Department of Psychiatry, Miguel Servet Hospital, Aragon Institute of Health Sciences (I+CS), Zaragoza, Spain
†Primary Care Prevention and Health Promotion Research Network (RedIAPP, ISCIII, Madrid, Spain)
‡Centre for the Economics of Mental and Physical Health, Institute of Psychiatry, King’s College London, De Crespigny Park
¶Personal Social Services Research Unit (PSSRU), London School of Economics and Political Science (LSE), London, UK
J.V.L. is grateful to the “Carlos III Healthcare Institute” (Red RD06/0018/0017) for a postdoctoral contract. Funded by a grant from the “Catalan Agency for Health Information, Assessment and Quality” (Barcelona, Spain) (AATRM 077/25/06). The authors declare no conflict of interest.
Reprints: Juan V. Luciano, PhD, Research and Development Unit, Parc Sanitari Sant Joan de Déu., C/Doctor Antoni Pujadas 42, Sant Boi de Llobregat, Barcelona 08830, Spain (e-mail: firstname.lastname@example.org).
Received March 20, 2012
Accepted August 25, 2012