D C W M Vos-Vromans1, R J E M Smeets2,3,4, I P J Huijnen2,3,4, A J A Köke4, W M G C Hitters5, L J M Rijnders1, M Pont6, B Winkens7, J A Knottnerus8. 1. Revant Rehabilitation Centre Breda, Breda, The Netherlands. 2. Department of Rehabilitation Medicine, Research School CAPHRI Maastricht University, Maastricht, The Netherlands. 3. Department of Rehabilitation Medicine, Academic Hospital Maastricht, Maastricht, The Netherlands. 4. Adelante Centre of Expertise in Rehabilitation and Audiology, Hoensbroek, The Netherlands. 5. Rehabilitation Centre Blixembosch, Eindhoven, The Netherlands. 6. Reade Centre of Rheumatology and Rehabilitation, Amsterdam, The Netherlands. 7. Department of Methodology and Statistics, Research School CAPHRI Maastricht University, Maastricht, The Netherlands. 8. Department of General Practice, Research School CAPHRI Maastricht University, Maastricht, The Netherlands.
Abstract
OBJECTIVES: The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS). DESIGN: Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT. SETTING: Four rehabilitation centres in the Netherlands. SUBJECTS: A total of 122 patients participated in the trial. MAIN OUTCOME MEASURES: Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation. RESULTS: A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant. CONCLUSION: This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial.
RCT Entities:
OBJECTIVES: The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS). DESIGN: Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT. SETTING: Four rehabilitation centres in the Netherlands. SUBJECTS: A total of 122 patients participated in the trial. MAIN OUTCOME MEASURES: Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation. RESULTS: A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant. CONCLUSION: This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial.
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