A Multicenter Randomized Controlled Trial Comparing Immediate and 6-Month Follow-up Effects of Two Group Programs on Fatigue and Self-Efficacy in People with MS
Fatigue is a common symptom among people with multiple sclerosis (MS). A structured group program Fatigue Take Control (FTC) was developed based on the Fatigue and MS clinical practice guideline. Despite being widely used by chapters of the National MS Society (NMSS), the effectiveness of FTC in decreasing fatigue or improving self-efficacy has not been demonstrated.
To determine whether MS participants in the FTC program experienced decreased fatigue and increased self-efficacy compared to those in a general MS education program referred to as MS Take Control (MSTC).
MS subjects with Modified Fatigue Impact Scale scores (MFIS) >24 were randomized to participate in FTC or MSTC. Subjects took the MFIS and the MS Self-Efficacy Scale (MSSE) at baseline (Visit 1), completion of their assigned program (Visit 8) and 6 months later (Visit 10). Both programs entailed participating in small groups led by a trained facilitator and consisted of 6 weekly sessions each lasting 2 hours. FTC differed from MSTC in two ways. The content of FTC focused on fatigue management with education and behavioral change and included goal setting and emphasis on participant engagement in finding ways to improve their fatigue. MSTC consisted of participants reading a different NMSS pamphlet on some aspect of MS before each session and discussing the content of the pamphlet at the session.
218 subjects were randomized at 4 sites. Baseline MFIS and MSSE scores did not differ between the two groups. MFIS scores improved in both groups between Visit 1 and Visit 8 (mean -4.1, p<0.0001) and between Visit 1 and Visit 10 (mean -5.0, p<0.0001) but did not differ between the two groups. The FTC group improved significantly on the MSSE compared with the MSTC group (mean increase of 45.5 vs -15.8, p=0.04) at Visit 8 but not at Visit 10 (mean increase of 38.9 vs 21.3, p=0.59).
Small group programs improved fatigue in MS participants with the effect increasing slightly 6 months after the program. Participants taking FTC demonstrated significant improvement in self-efficacy initially compared to MSTC that was sustained for 6 months but no longer significantly different from MSTC. The results of this study suggest the need to develop a program for fatigue management that includes support for participants to accomplish goals they set for themselves.