Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue

PHASE4CompletedINTERVENTIONAL
Enrollment

343

Participants

Timeline

Start Date

November 15, 2018

Primary Completion Date

August 24, 2021

Study Completion Date

November 30, 2021

Conditions
Multiple Sclerosis
Interventions
BEHAVIORAL

Telephone-based Cognitive Behavioral Therapy

"Cognitive behavioral therapy (CBT) is a behavioral-based treatment that promotes effective self-management skills, including adaptive thought processes and behaviors (i.e. coping skills). CBT also commonly teaches goal-setting and behavioral activation strategies for engaging in physical, social, and other valued activities in the context of fatigue."

DRUG

Modafinil

Modafinil is a safe, well-tolerated and effective wake-promoting agent (oral medication) that is FDA-approved for the treatment of fatigue related to sleep disorders. Modafinil is also one of the most commonly used medications for multiple sclerosis related fatigue in clinical practice, with doses ranging from 50 - 400 mg per day, in divided doses (once to twice daily).

Trial Locations (2)

48109

The University of Michigan, Ann Arbor

98195

The University of Washington, Seattle

All Listed Sponsors
collaborator

University of Washington

OTHER

collaborator

Patient-Centered Outcomes Research Institute

OTHER

collaborator

National Multiple Sclerosis Society

OTHER

lead

University of Michigan

OTHER

NCT03621761 - Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue | Biotech Hunter | Biotech Hunter