Real world observation of fatigue in multiple sclerosis comparing self-guided online cognitive behavioral therapy versus psychoeducation.

BACKGROUND: Fatigue is a common symptom in people with multiple sclerosis (pwMS) with severe implications. A self-guided, internet-based intervention to reduce fatigue in MS, based on cognitive behavioral therapy (CBT), is approved as a digital health application (DiGA) in the German healthcare system. However, real-world evidence for efficacy is lacking. METHODS: Of the 165 patients screened for fatigue using the Fatigue Scale for Motor and Cognitive Functions (FSMC), 129 were diagnosed with fatigue (FSMC ≥ 43) and enrolled. Patients with fatigue were randomized 1:1 to either a 12-week CBT-based online intervention (elevida, a CE-certified, self-guided DiGA for the management of MS-related fatigue; n = 64) or a psychoeducation arm (n = 65). After 12 weeks, patients in the psychoeducation group could cross-over to the CBT-based online intervention group. The primary outcome was FSMC-change. RESULTS: The 12-week follow-up showed a reduction in FSMC in the primary CBT-based online intervention group (repeated measures ANOVA: F(1,48) = 10.99, p = 0.002), as well as the crossover-group (repeated measures ANOVA: F(1,15) = 5.81, p = 0.029). However, between-group analyses did not demonstrate superiority of the CBT-based online intervention over psychoeducation (mean difference 1.8 points, 95% CI -2.0 to 5.6; p = 0.35). CONCLUSION: Our results highlight CBT-based online interventions as promising supportive tools for managing cognitive fatigue in pwMS.