Alleviating fatigue in multiple sclerosis with two online self-management programs.

Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

This project will test whether two different online self-management programs help reduce fatigue in adults with multiple sclerosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Accelerated Cure Project for Multiple Sclerosis (Academic / other)
• Locations: 6 sites (Washington D.C., District of Columbia and 5 other locations)
• Trial ID: NCT06441617 on ClinicalTrials.gov

What this trial studies

This decentralized, randomized 3-arm trial will enroll about 2,000 adults with MS across VA centers and the iConquerMS network to ensure diverse representation. Participants will be randomized to one of two online fatigue-management programs plus their usual MS care, or to usual MS care alone. The active online intervention phase lasts 6 months with total study participation lasting one year and remote follow-up assessments. The design emphasizes scalability by using self-administered internet-based programs and broad geographic recruitment within the U.S.

Who should consider this trial

Good fit: Ideal candidates are adults (22+) in the U.S. with a physician-confirmed diagnosis of MS, elevated fatigue on the Fatigue Severity Scale, fluent in English, willing to use internet-based programs for 24 weeks, and able to provide informed consent.

Not a fit: Patients unlikely to benefit include those without internet access or English fluency, those with a recent MS relapse or recent start of a disease-modifying therapy, and those already enrolled in another interventional trial.

Why it matters

Potential benefit: If successful, these online programs could reduce fatigue and improve daily functioning for many people with MS, especially those who cannot easily access in-person services.

How similar studies have performed: Previous smaller or clinic-based programs, including digital cognitive-behavioral and energy-conservation approaches, have shown modest benefits for MS fatigue, but large-scale, decentralized confirmation is limited.

Eligibility criteria

Inclusion Criteria:

* Informed consent by person with MS
* Living in the US
* Age ≥ 22
* Confirmed diagnosis of MS by a physician, who is a neurologist or has access to a neurologist's statement of diagnosis
* Fatigue Severity Scale score at or above eligibility threshold
* Fluent in English
* Willingness to engage in self-administration of an online intervention for 24 weeks and complete follow-up assessments
* Access to the internet and e-mail with a compatible device (smartphone, computer, or tablet)
* No MS relapse / no steroid treatment in the 4 weeks prior to answering the screening questionnaire (self-reported)
* No disease-modifying therapeutic (DMT) started in the 4 weeks prior to answering the screening questionnaire (self-reported)

Exclusion Criteria:

* Unwilling or unable to consent
* Refusal to saving, processing and forwarding of pseudonymized data
* Concurrent participation in another interventional trial

Where this trial is running

Washington D.C., District of Columbia and 5 other locations

• Washington VA Medical Center — Washington D.C., District of Columbia, United States (Recruiting)
• Baltimore VA Medical Center — Baltimore, Maryland, United States (Recruiting)
• iConquerMS — Waltham, Massachusetts, United States (Recruiting)
• Portland VA Medical Center — Portland, Oregon, United States (Recruiting)
• Nashville VA Medical Center — Nashville, Tennessee, United States (Recruiting)
• Seattle VA Medical Center — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Grace Okafor

Conditions Multiple Sclerosis; Fatigue