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Effectiveness of a group-based self-management program for people with chronic fatigue syndrome: a randomized controlled trial [with consumer summary] |
Pinxsterhuis I, Sandvik L, Strand EB, Bautz-Holter E, Sveen U |
Clinical Rehabilitation 2017 Jan;31(1):93-103 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; 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 evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome. DESIGN: A randomized controlled trial. SETTING: Four mid-sized towns in southern Norway and two suburbs of Oslo. SUBJECTS: A total of 137 adults with chronic fatigue syndrome. INTERVENTION: A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care. MAIN MEASURES: Primary outcome measure: Medical Outcomes Study-Short Form-36 physical functioning subscale. SECONDARY OUTCOME MEASURES: Fatigue severity scale, self-efficacy scale, physical and mental component summary of the Short Form-36, and the illness cognition questionnaire (acceptance subscale). Assessments were performed at baseline, and at six-month and one-year follow-ups. RESULTS: At the six-month follow-up, a significant difference between the two groups was found concerning fatigue severity (p = 0.039) in favor of the control group, and concerning self-efficacy in favor of the intervention group (p = 0.039). These significant differences were not sustained at the one-year follow-up. No significant differences were found between the groups concerning physical functioning, acceptance, and health status at any of the measure points. The drop-out rate was 13.9% and the median number of sessions attended was seven (out of eight). CONCLUSIONS: The evaluated self-management program did not have any sustained effect, as compared with receiving usual care.
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