Evaluation of a web-based program for the adoption of wellness behaviors to self-manage fatigue and improve quality of life among people with multiple sclerosis: A randomized waitlist-control trial.

backgroundWellness is a promising area of research in multiple sclerosis (MS); however, considerable questions remain regarding the efficacy of behavioral interventions to improve wellness and which delivery methods yield favorable results.

objectiveTo evaluate the efficacy of a wellness intervention consisting of diet, stress reduction techniques, sleep hygiene, and exercise, delivered via a 7-week web-based program with no tailored intervention support (e.g., counseling or resources) from the study team, on quality of life (QoL) and fatigue among people with MS.

methodsIndividuals (n = 100) with self-reported physician's diagnosis of relapsing-remitting MS or clinically isolated syndrome were recruited to enroll in this randomized waitlist-control trial consisting of three timepoints at 0, 12, and 24 weeks. Participants were randomized to begin the intervention at baseline (INT; n = 51) or to a waitlist to begin the intervention after the 12-week timepoint (WLC; n = 49), and both groups were followed for 24 weeks.

resultsAt 12-weeks, 95 participants (46 INT and 49 WLC) completed the primary endpoint and 86 (42 INT and 44 WLC) completed the 24-week follow-up. Compared to baseline, the INT group had a significant increase in physical QoL (5.43 ± 1.85; P = 0.003) at 12-weeks which was maintained at 24-weeks. Physical QoL values in the WLC group did not significantly increase between weeks 12 and 24 (3.24 ± 2.03; P = 0.11); however, physical QoL values significantly improved compared to week 0 values (4.00 ± 1.87; P = 0.033). Neither group had significant changes in mental QoL. The INT group had a mean baseline to 12-week change of ‑5.06 ± 1.79 (P = 0.005) for MFIS and -0.68 ± 0.21 (P = 0.002) for FSS, both of which were maintained at 24-weeks. The 12- to 24-week changes for the WLC group were -4.50 ± 1.81 (P = 0.013) for MFIS and -0.44 ± 0.17 (P = 0.011) for FSS. At 12-weeks, the INT group had significantly greater reductions in fatigue compared to the WLC (P = 0.009 for both MFIS and FSS). There were no between-group mean differences for physical or mental QoL, but a significantly higher proportion of participants had clinically significant improvement in physical QoL in the INT group (50%) compared to the WLC group (22.5%) at 12-weeks (P = 0.006). The 12-week intervention effect was similar during the active intervention phase (i.e., baseline to 12 weeks for INT and 12 to 24 weeks for WLC) in each group. Course completion rates significantly differed between groups with 47.9% of the INT group and 18.8% of the WLC group completing the course (P = 0.01).

conclusionA wellness intervention delivered via a web-based program, without tailored support, resulted in significant improvements in fatigue compared to control.

trial registrationClinicaltrials.gov Identifier: NCT05057676.