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Clinical Trial: Cognitive Behavioral Therapy, Modafinil, or Both for MS Fatigue ("COMBO-MS")

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Details
Type of MS: PPMS|PRMS|RRMS|SPMS
Treatment mode of action: To improve fatigue
Number of Subjects: 300
Medication: Cognitive Behavioral Therapy, Modafinil, or Both
Location: Michigan|Washington
Institutions: University of Michigan, Ann Arbor, University of Washington, Seattle Contact Information
Please see contact for each site below.

Funding:

Patient-Centered Outcomes Research Institute (PCORI)

Description

Many individuals with MS suffer from fatigue, which can be their most disabling symptom. Research is needed to figure out how to match treatments to individual patients so that the treatments will have the greatest effect. 

This clinical trial will compare the effectiveness of 3 treatments for fatigue in MS: 1) a commonly used behavioral treatment strategy (telephone-based cognitive behavioral therapy (CBT), 2) a commonly used medication (modafinil), and 3) a combination of both therapies. Each participant will receive one of these 3 treatments for a total of 12 weeks.

Throughout the trial, participants will be given several short online surveys  to assess fatigue, sleep, and other symptoms. Before and after treatment, participants will wear a watch-like device for 7 days to measure symptoms as well as sleep and physical activity.  Study visits are currently being conducted via virtual visit using Zoom for Healthcare.

If you reside in Michigan and interested in participating please visit our study site:
https://umhealthresearch.org/#studies/HUM00143320
 
If you reside in Washington state and have questions or are interested in participating, contact:
Leah Willover
(206) 598-0501
comboms@uw.edu
 

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