Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronic fatigue syndrome: study protocol for a randomised controlled trial (FatiGo)

Trials

André J Knottnerus⁶  Silvia MAA Evers⁴  Minou WMGC Hitters³  Albère JA Köke⁵  Menno Pont¹  René RM Gorrissen²  Leonie JM Rijnders²  Rob JEM Smeets⁵  Desirée CWM Vos-Vromans² 

[1] Reade Centre for Rheumatology and Rehabilitation, P.O Box 58271, 1040, HG, Amsterdam, The Netherlands;Revant Rehabilitation Centre Breda, Brabantlaan 1, 4817, JW, Breda, The Netherlands;Rehabilitation Centre Blixembosch, P.O. Box 1355, 5602, BJ, Eindhoven, The Netherlands;Department of Health Organization Policy and Economics, Research School CAPHRI Maastricht University, P.O. Box 616, 6200, MD, Maastricht, The Netherlands;Adelante Centre of Expertise in Rehabilitation and Audiology, P.O. Box 88, 6430, AB, Hoensbroek, The Netherlands;Department of General Practice, Research School CAPHRI Maastricht University, P.O. Box 616, 6200, MD, Maastricht, The Netherlands

关键词: Quality of life;    Fatigue;    Cost-effectiveness;    Multidisciplinary rehabilitation treatment;    CBT;    Chronic fatigue syndrome;   

Others  :  1095561
DOI  :  10.1186/1745-6215-13-71

 received in 2011-03-17, accepted in 2012-04-16,  发布年份 2012

【 摘 要 】

Background

Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo (Fatigue-Go) trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome.

Methods

One hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators—self-efficacy, causal attributions and present-centred attention-awareness—will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life satisfaction, patient personal goals, self-rated improvement and economic costs. The primary analysis will be based on intention to treat, and longitudinal analysis of covariance will be used to compare treatments.

Discussion

The results of the trial will provide information on the effects of cognitive behavioural therapy and multidisciplinary rehabilitation treatment at 6 and 12 months follow-up, mediators of the outcome, cost-effectiveness, cost-utility, and the influence of treatment expectancy and credibility on the effectiveness of both treatments in patients with chronic fatigue syndrome.

Trial registration

Current Controlled Trials ISRCTN77567702.

【 授权许可】

   
2012 Vos-Vromans et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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