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Alone or Together, CBT and Modafinil Improve MS-Related Fatigue

The wake-promoting drug modafinil, cognitive behavioral therapy (CBT), and a combination of both were associated with comparable, significant improvement in fatigue at 12 weeks in patients with multiple sclerosis (MS) and problematic fatigue, according to a study published in The Lancet Neurology.

“These treatments, both individually and as a combination, should be considered as potential options for people with multiple sclerosis with chronic, problematic fatigue,” said senior author Anna L. Kratz, PhD, a professor of physical medicine and rehabilitation at the University of Michigan, Ann Arbor, Michigan.

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The comparative effectiveness trial included more than 300 patients with MS and scores of 4 or higher on the Fatigue Severity Scale. Participants were randomly assigned to CBT delivered over the phone, modafinil, or combination therapy with both CBT and modafinil for 12 weeks.

More than 60% of patients in each group reported clinically meaningful improvement in fatigue per the Modified Fatigue Impact Scale (MFIS), according to the study. Within-group MFIS reductions were 15.20 for CBT, 16.90 with modafinil, and 17.30 with combination therapy. Combination therapy was not associated with increased improvement in fatigue compared with the individual interventions, adjusted analysis showed.

Patients who had received CBT alone maintained lower fatigue scores at an additional 12-week follow-up after the interventions ended, researchers reported. 

Additionally, the team reported that sleep hygiene played a role in the effect of the interventions. Patients with poor sleep hygiene at baseline tended to improve more with CBT, while patients with healthy sleep habits at baseline had better outcomes with modafinil.

“As sleep disturbances also contribute to fatigue in people with MS, it is important to avoid selecting fatigue treatments that could make sleep worse,” said first author Tiffany J. Braley, MD, director of the MS/neuroimmunology division and co-founder of the MS fatigue and sleep clinic at the University of Michigan. “Behavioral treatments such as CBT that include sleep education may be preferable for people with MS who have poor sleep habits.”

 

References

Braley TJ, Ehde DM, Alschuler KN, et al. Comparative effectiveness of cognitive behavioural therapy, modafinil, and their combination for treating fatigue in multiple sclerosis (COMBO-MS): a randomised, statistician-blinded, parallel-arm trial. Lancet Neurol. 2024;23(11):1108-1118. doi:10.1016/S1474-4422(24)00354-5

For multiple sclerosis, medication and cognitive behavioral therapy can reduce fatigue. News release. Michigan Medicine - University of Michigan; October 16, 2024. Accessed October 25, 2024.