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A randomized controlled trial of a wellness intervention for women with fibromyalgia syndrome [with consumer summary]
Stuifbergen AK, Blozis SA, Becker H, Phillips L, Timmerman G, Kullberg V, Taxis C, Morrison J
Clinical Rehabilitation 2010 Apr;24(4):305-318
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 x 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.

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