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Online Therapy for Fatigue in Multiple Sclerosis
(CAFE-MS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Accelerated Cure Project for Multiple Sclerosis

No Placebo Group

Trial Summary

What is the purpose of this trial?

CAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis (MS). Although they differ, both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue. This large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 Veterans Affairs (VA) sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials. The study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial.

Research Team

Eligibility Criteria

This trial is for adults over 22 living in the US with Multiple Sclerosis who experience fatigue. Participants must have internet access, be fluent in English, and not have had an MS relapse or started a new disease-modifying therapy within the last 4 weeks.

Inclusion Criteria

I haven't started any new disease treatments in the last 4 weeks.

Informed consent by person with MS

My fatigue levels are high according to a specific scale.

See 7 more

Exclusion Criteria

Unwilling or unable to consent

Refusal to saving, processing and forwarding of pseudonymized data

Concurrent participation in another interventional trial

Treatment Details

Interventions

Online Therapy for Fatigue (Behavioural Intervention)

Trial OverviewCAFE-MS is testing two online programs designed to manage fatigue in MS patients. It's a randomized trial where participants either get their usual treatment, one of the online programs plus usual treatment, or another program plus usual treatment.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Fatigue Program A added to Treatment as UsualExperimental Treatment1 Intervention

An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.

Group II: Fatigue Program B added to Treatment as UsualActive Control1 Intervention

Fatigue Program B will use a web-based interface with similar design and functionality as Fatigue Program A.

Group III: Treatment as UsualActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Accelerated Cure Project for Multiple Sclerosis

Lead Sponsor

Trials

Recruited

30,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

Recruited

10,600+

Colonel Mark G. Hartell

Congressionally Directed Medical Research Programs

Director, Congressionally Directed Medical Research Programs since 2022

PhD in Analytical Chemistry from Auburn University, MS in Biophysical Chemistry from Ohio State University, BS in Chemistry from State University of New York at Oswego

Dr. Sarah Goldman

Congressionally Directed Medical Research Programs

Chief Medical Officer since 2023

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer