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A randomized controlled trial of a wellness intervention for women with fibromyalgia syndrome

Objective: To examine the effects of a wellness intervention, Lifestyle Counts, for women with fibromyalgia syndrome on the level of self-efficacy for health-promoting behaviours, health-promoting activity and perceived quality of life. Design: A randomized controlled single-blinded trial with treatment and attention-control groups. Setting: Community in the southwestern United States. Subjects: Convenience sample of 187 women (98 treatment, 89 attention control) with fibromyalgia syndrome (mean age = 53.08 years, SD 9.86). Intervention: The two-phase Lifestyle Counts intervention programme included lifestyle change classes for eight weeks, with goal-setting and telephone follow-up for three months. Participants in the attention-control group were offered an equivalent amount of contact in classes on general disease-related information and health education topics and unstructured follow-up phone calls. Participants were followed for a total of eight months after baseline. Outcome measures: Self-report instruments measuring self-efficacy for health behaviours, health-promotion behaviours and health-related quality of life (SF-36 and the Fibromyalgia Impact Questionnaire) were completed at baseline, two months (after the classes), five months (after telephone follow-up) and at eight months. Results: Both groups improved significantly (P<0.05) over time on the measures of self-efficacy, health behaviours, fibromyalgia impact and quality of life. There were significant group × time interactions for scores on the Health Promoting Lifestyle II subscales of physical activity and stress management. Conclusions: The Lifestyle Counts wellness intervention holds promise for improving health-promoting behaviours and quality of life of women with fibromyalgia syndrome.