Tests two online programs for fatigue in people with multiple sclerosis
Tests two online programs that teach people with MS to manage fatigue.
Plain-language title generated from the registry record
Registry title: Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
Key facts
- Where
- Baltimore, Nashville, Portland, Seattle, Waltham, and Washington D.C., United StatesSee the 6 sites
Where in United States
- Baltimore VA Medical CenterBaltimore, United StatesNo longer taking part
- Nashville VA Medical CenterNashville, United StatesNo longer taking part
- Portland VA Medical CenterPortland, United StatesNo longer taking part
- Seattle VA Medical CenterSeattle, United StatesNo longer taking part
- iConquerMSWaltham, United StatesNo longer taking part
- Washington VA Medical CenterWashington D.C., United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Accelerated Cure Project for Multiple Sclerosis
- Trial code
- NCT06441617
- Record updated
- 4 September 2026
- Original description
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.Read full original descriptionShow less
Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
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.
Inclusion: 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: Concurrent participation in another interventional trial; Unwilling or unable to consent; Refusal to saving, processing and forwarding of pseudonymized data.