Abstract Details

Title Long-term efficacy of cognitive-behavioral approaches (CBT) in the management of fatigue in patients with relapsing remitting multiple sclerosis (RRMS): a randomized, parallel-group, multicenter, open-label, controlled trial versus standard care

Topic Multiple Sclerosis

Presentation(s) S19 - MS Biomarkers and Symptom Management (2:36 PM-2:48 PM)

Poster/Presentation
Number 009

Background

Fatigue is one of the most frequent and one of the worst reported symptoms in MS.

Evidences for effectiveness of pharmacological and non-pharmacological therapies are limited. RCTs using CBT have short term efficiency but the positive effect wears off over time not exceeding 6 months.

Booster session might enhance the long term benefits by reinforcing the internalizations processes

Objective The objective of this RCT, open-label study is to evaluate the efficacy and tolerability of a 6-week CBT program with booster sessions for 1 year, compared with standard care, on the severity and impact of fatigue at 12 months in a population of patients with RRMS and fatigue.

Design/Methods Our study is based on the FACETS program (Thomas 2013) with the addition of 4 booster sessions over 12 months. It is a randomized, parallel-group, multicenter, open-label, controlled trial versus standard management. The primary endpoint is the comparison between arms, based on the evolution of the fatigue score assessed with the Modified Impact Scale (MFIS) between M0 and M12

Results

N = 105 were randomized: 57 patients in the FACETS group and 48 in the control group.

According to the protocol-defined primary endpoint analysis, at 12 months, the adjusted mean MFIS was 41.2 ± 15.73 in the FACETS group, and 50.23 ± 13.39 in the control group (p<0.01)

Differences at M12 in favor of the FACETS group were found for the FIS, FSS, MSIS PHY.

The per-protocol analysis, (patients who had completed at least 4 sessions and were present at 12 months), showed that the positive effect of CBT was maintained up to 18 months.

The program was well tolerated by the patients

Conclusions

This study is the first RCT demonstrating long term efficacy in the treatment of fatigue in MS patients by using CBT program with booster sessions.

Authors/Disclosures
Olivier Heinzlef, MD (Hospital De Poissy) PRESENTER	Dr. Heinzlef has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Heinzlef has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Heinzlef has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Edimark.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Eric Manchon, MD (Hopital de Gonesse)	Eric Manchon, MD has nothing to disclose.
	No disclosure on file
	No disclosure on file