Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This clinical trial will compare the effectiveness of 3 treatments for fatigue in Multiple
Sclerosis: 1) a commonly used behavioral treatment strategy (telephone-based cognitive
behavioral therapy), 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.
Hypotheses are that, at 12 weeks, treatment with combination therapy will overall lead to
greater reductions in fatigue impact, fatigue severity, and fatigability compared to
monotherapy, and that comorbid depression, sleep disturbances, and baseline disability level
will be important effect modifiers that influence treatment effect and adherence.
Phase:
Phase 4
Details
Lead Sponsor:
University of Michigan
Collaborators:
National Multiple Sclerosis Society Patient-Centered Outcomes Research Institute University of Washington