Patients report greater benefits with CBT, modafinil combination therapy for fatigue in MS

Cognitive behavioral therapy, modafinil and combination therapy were each linked to reduced fatigue in patients with MS, although patients reported greater benefits with combination therapy, according to research presented at ACTRIMS 2023.

“No single treatment is broadly effective for MS-related fatigue,” Tiffany J. Braley, MD, MS, clinical associate professor of neurology at University of Michigan Health, and colleagues wrote. “Although existing behavioral and pharmacological therapies may each improve fatigue for some individuals, their comparative effectiveness and that of their simultaneous combination have not been studied.”

Braley and fellow researchers sought to compare relative benefits and drawbacks to introducing telephone-based cognitive behavioral therapy, modafinil or a combination of both to address fatigue in patients with MS.

Their study included 336 individuals who were randomized on a 1:1:1 basis to receive CBT (n = 114), modafinil (n = 114) or both (n = 108) for 12 weeks. Researchers assessed fatigue, measured by the Modified Fatigue Impact Scale (MFIS), at baseline and study conclusion, and included modifiers such as depression, measured via the Patient Health Questionnaire-8; sleep, via Sleep Hygiene Index scores and Epworth Sleepiness Scale; disability level, through the self-reported Expanded Disability Status Scale; and MS subtype.

Participants self-reported changes in activity, symptoms and quality of life, which were assessed by Patient Global Impression of Change (PGIC) score, and researchers analyzed treatment effect on change in MFIS via multiple linear regression models.

At 12 weeks, results showed that CBT, modafinil and combination therapy were each associated with significant MFIS reductions of greater than one standard deviation: 15.2 (SD = 11.9), 16.9 (SD = 15.9) and 17.3 (SD = 16.2), respectively.

In addition, more than two-thirds of patients in each treatment group had at least a 10-point reduction in overall MFIS score. Researchers also reported that CBT demonstrated the greatest benefit for MFIS scores in participants with worse sleep hygiene, and sleepiness was linked to MFIS score change.

Further, mean PGIC scores were elevated for combination therapy (5.1 ± 1.6) compared with CBT alone (4.7 ± 1.6) or modafinil alone (4.5 ± 1.7).

“Phenotypic differences and treatment goals should be considered when selecting interventions, to offer a more personalized approach to management,” Braley and colleagues wrote.