Fibromyalgia syndrome (FMS) is a common, chronic musculoskeletal disorder and a growing cause of disability and increased health care utilization. Current treatment focuses largely on pharmacological intervention, which is often ineffective at improving symptoms and functional status. Recent research suggests that disease self-management can be efficacious in the short-term at reducing symptom severity and improving function in persons with FMS. The most common forms of FMS self-management are coping skills, training (behavioral/education) and exercise. Limited in number, most FMS self-management studies examine the short-term effects of one form or the other, with most using the coping skills training approach. Little data exist to examine the long-term effects of these interventions, the potential additive effect of combining coping skills training with a comprehensive, group exercise program or an approach for promoting long-term compliance of these interventions. The objective of this proposal is for the PI to acquire new competencies in the area of health behavior; to expand research skills; and to apply this knowledge in a study to identify the optimal approach to FIVIS self-management. The PI will combine formal learning in health and social behavior, research design and analysis, and ethics in clinical research with informal learning, in a proven academic training environment under the guidance of a committed mentor. The study is a randomized, controlled trial comparing coping skills training (the Arthritis Foundation Fibromyalgia Self-Help Course (FSHC)) with a comprehensive exercise program (previous work of PI), a combination (the FSHC plus the exercise program) or no treatment (waiting list control). Each intervention period will last 16 weeks and include group sessions led by trained personnel. Subjects will be followed for 6 months after completing the intervention to evaluate the short-term effect of each program. At 6 months, subjects will be randomized into two groups-one group will receive a 4 week refresher course of their original intervention every 6 months and the other group will receive no further intervention. Long-term follow up will be for 24 months after completing the 16 week intervention period. Subjects will include 200 women (four groups of 50), 25 to 65 years old with a confirmed diagnosis of FMS. Participants will undergo blinded assessment at the Beth Israel Deaconess Medical Centers GCRC at five time points-baseline, completion of the 16-week intervention and 6, 12 and 24 month follow up. We will assess health and functional status (FIQ, SF36), symptom severity (FIQ, SF36, Beck scales), self-efficacy (Arthritis Self-Efficacy Scale), fitness (muscle strength, cardiovascular fitness, flexibility) and health care utilization (direct and indirect costs). The study will improve treatment outcomes for persons with FMS by identifying the optimal self-management program.
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