The positive effect of cognitive behavioral therapy for the treatment of fatigue in patients with multiple sclerosis: Results of a randomized controlled trial

Abstract

Background: MS‐related fatigue is a common symptom in Multiple Sclerosis (MS) that restricts societal participation. Literature suggests that Cognitive Behavioral Therapy (CBT) alleviates MS‐related fatigue, but evidence is inconclusive. The study objective was to evaluate the effectiveness of CBT to improve MS‐related fatigue and participation in patients with MS. Methods: In a multicenter, assessor‐masked, randomized‐controlled trial in 3 Dutch healthcare institutions, participants with severe MS‐related fatigue were assigned to the CBT or control study group. The CBT study group received twelve individual face‐to‐face sessions with a certified psychologist; the control study group received 3 individual sessions with an MS‐nurse, both for a duration of 16 weeks. Assessments took place at baseline, 8, 16 (i.e. post‐intervention), 26 and 52 weeks follow‐up. Primary outcomes were the Checklist Individual Strength‐fatigue subscale (CIS20r‐fatigue) and the Impact on Participation and Autonomy questionnaire (IPA). Data were analyzed with the intention‐to‐treat principle using Mixed Model Analysis. The Controlled Trials registration number is ISRCTN58583714. Findings: Between December 2011 and August 2014, 91 patients were randomly assigned to the CBT (n=44) or to the MS‐nurse study group (n=47). The between‐group analysis showed a positive post‐intervention effect for CBT on the CIS20r‐fatigue (T16: ‐6•7 [95%CI ‐10•7; ‐2•7] points) that diminished during follow up (T26: ‐3•5 [95%CI ‐7•4; 0•5]; T52: 0•5 [95%CI ‐3•6; 4•4]). No clinically relevant effects were found on societal participation. Post‐intervention (T16), 22 out of 39 in the CBT, and 9 out of 37 patients in the control study group showed a clinically‐relevant improvement of 8‐points or more on the CIS20r‐fatigue, leading to a number needed to treat of 3•3 (95%CI 1•9;10•6). Interpretation: Severe MS‐related fatigue can be reduced effectively with CBT. However, effects wear off after cessation of treatment, societal participation does not improve.