For a study, the researchers sought to compare the efficacy and tolerability of a 6-week cognitive-behavioral approaches (CBT) program with booster sessions for a year to conventional therapy on the severity and impact of fatigue at 12 months in a group of individuals with RRMS and fatigue. The research was based on the FACETS program (Thomas 2013), with 4 booster sessions spread out over a 12-month period. It was a multicenter, randomized, parallel-group, open-label, controlled trial compared to standard management. The primary objective was a comparison of arms based on the evolution of fatigue score as measured by the Modified Impact Scale (MFIS) from M0 to M12. There were 105 patients in all, including 57 in the FACETS group and 48 in the control group. The adjusted mean MFIS in the FACETS group was somewhere between 41.2 and 15.73 at 12 months, compared to somewhere between 50.23 and 13.39 in the control group (p<0.01), according to the protocol-defined primary endpoint analysis. The FIS, FSS, and MSIS PHY all showed differences at M12 in favor of the FACETS group. The favorable effect of CBT was maintained up to 18 months in the per-protocol analysis (patients who had completed at least 4 sessions and were present at 12 months). The patients tolerated the program well. This was the first RCT to show the long-term efficacy of a CBT program with booster sessions in treating fatigue in MS patients.

 

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