BACKGROUND: The purpose of this study was to assess the efficacy of cognitive behavior therapy (CBT) as a treatment for multiple sclerosis (MS) fatigue. METHODS: A randomized controlled design was used where 72 patients with MS fatigue were randomly assigned to eight weekly sessions of CBT or relaxation training (RT). RT was designed to control for therapist time and attention. Participants were assessed before and after treatment, and at 3 and 6 months posttreatment. The primary outcome was the Fatigue Scale. Secondary outcomes included measures of stress, mood, and fatigue-related impairment. RESULTS: Analysis was by intention-to-treat. A group by time interaction showed that the CBT group reported significantly greater reductions in fatigue across the 8 months compared with the RT group (p < 0.02). Calculated effect sizes for fatigue from baseline to the end of treatment were 3.03 (95% confidence interval, 2.22 to 3.68) for the CBT group and 1.83 (95% confidence interval, 1.26 to 2.34) for the RT group. Results also indicted that both groups showed clinically significant decreases in fatigue defined as fatigue levels equivalent or less than those reported by a non-fatigued healthy comparison group. There were no significant interactions between group and any of the secondary outcome variables, with both groups showing improvements over time on all measures. INTERPRETATION: Both CBT and RT appear to be clinically effective treatments for fatigue in MS patients, although the effects for CBT are greater than those for RT. Even 6 months after treatment, both treatment groups reported levels of fatigue equivalent to those of the healthy comparison group.

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