Less Fatigue in Multiple Sclerosis With CBT and Modafinil

TOPLINE:

Fatigue related to multiple sclerosis (MS) was significantly reduced following 12 weeks of treatment with cognitive behavioral therapy (CBT) and modafinil, either alone or in combination, a new study shows.

METHODOLOGY:

• Intent-to-treat analysis from the randomized, analyst-blinded, parallel-arm trial included 312 adults with MS and problematic fatigue (76% women; 85% White).
• Participants were randomized to receive CBT delivered by telephone (n = 103), modafinil (n = 107), or a combination of the two (n = 102) for 12 weeks.
• The trial allowed for flexible dosing of modafinil (the most common dose was 100 mg daily).
• The primary outcome was the change in the Modified Fatigue Impact Scale (MFIS) score from baseline to 12 weeks, and secondary outcomes included changes in the ecological momentary assessment of fatigue intensity, interference, and perceived fatigability from baseline to 12 weeks.

TAKEAWAY:

• CBT, modafinil, and their combination all resulted in clinically meaningful reductions in fatigue, with mean reductions in MFIS scores of 15.20, 16.90, and 17.30, respectively.
• No significant difference in fatigue reduction was observed between the treatment groups.
• Participants with good sleep hygiene experienced a greater reduction in fatigue with modafinil, while those with poor sleep hygiene showed better outcomes with CBT.
• No relevant serious adverse events were encountered in the three groups, and the most common adverse events were insomnia, headache, and anxiety, predominantly encountered in the groups taking modafinil.

IN PRACTICE:

“Fatigue is one of the most common and debilitating symptoms of multiple sclerosis, yet there is still uncertainty about how available treatments should be used or how medication-based treatments compare to behavioral treatments in the real world. This research offers new evidence to show that both CBT and modafinil are comparably effective for MS fatigue, which could shape treatment approaches to one of the most challenging symptoms experienced by people with multiple sclerosis,” lead author Tiffany J. Braley, MD, MS, University of Michigan, Ann Arbor, Michigan, said in a press release.

SOURCE:

The study was published online on October 17 in The Lancet Neurology.

LIMITATIONS:

The absence of a placebo group may have influenced the observed effects. The study was not fully powered to detect all tests of heterogeneity of treatment effects. The virtual delivery of CBT may have limited the generalizability to in-person settings. The study’s reliance on self-reported measures may have introduced bias. 

DISCLOSURES:

The study was funded by the Patient-Centered Outcomes Research Institute and the National Multiple Sclerosis Society. Several authors disclosed ties with various institutions and receiving support from pharmaceutical companies, honoraria, patents, or unpaid leadership roles. Detailed disclosures are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.