BackgroundPatients 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.MethodsOne 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.DiscussionThe 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 registrationCurrent Controlled Trials ISRCTN77567702.