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

Background: Patients with chronic fatigue syndrome (CFS) experience extreme fatigue which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment of patients with CFS. Patients try many different therapies to overcome their fatigue. Although there is no consensus, Cognitive Behavioural Therapy (CBT) is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment (MRT), a combination of CBT with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between MRT and CBT for treatment of patients with CFS 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 CFS. Methods: One hundred and twenty patients, who meet the criteria of CFS, fulfil the inclusion criteria and signed the informed consent form, will be recruited into a randomised controlled trial. Both treatments, CBT and MRT, take 6 months to complete. Outcome will be assessed at 6 and 12 months after start of treatment. Two weeks after start of treatment, expectancy and credibility will be measured and patients are asked to write down their personal goals and score their current performance on these goals on a Visual Analogue Scale (VAS). At 6 and 14 weeks after start of treatment, primary outcome and three potential mediators; self-efficacy, causal attributions, 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.Trial registration: Current Controlled Trials ISRCTN77567702. Conclusions: The results of the trial will provide information on the effects of CBT and MRT 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 CFS.