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

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 improv