Online Therapy for Fatigue in Multiple Sclerosis

(CAFE-MS Trial)

Recruiting at 7 trial locations

Overseen By Grace Okafor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Accelerated Cure Project for Multiple Sclerosis

Disqualifiers: Concurrent interventional trial, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two online programs designed to help people with multiple sclerosis (MS) manage fatigue. Participants will either use one of these online fatigue programs alongside their usual MS treatment or continue with their usual treatment alone for six months. Afterward, those in the usual treatment group can choose an online program for the next six months. The trial seeks participants in the U.S. with a confirmed MS diagnosis who experience significant fatigue. Individuals with internet access who are ready to try a new approach to managing fatigue may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative solutions for managing MS-related fatigue.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop taking your current medications. It seems you can continue your usual MS treatment while participating.

What prior data suggests that these online programs are safe for managing fatigue in MS?

Research has shown that online cognitive behavioral therapy (CBT) effectively reduces fatigue in people with multiple sclerosis (MS). One study found that these online programs are generally easy to handle and help manage fatigue without causing significant side effects.

Both Fatigue Program A and Fatigue Program B use telemedicine, providing healthcare services over the internet. Studies have shown that telemedicine is safe for managing MS fatigue. Most participants find these online formats easy to use and report no major negative effects.

Participants in previous studies experienced positive results with these programs, noting improvements in their fatigue levels. These findings suggest that the online programs being tested are safe and could be a helpful addition to regular MS treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these online therapy programs for fatigue in multiple sclerosis because they offer a new, accessible way to manage symptoms. Unlike traditional methods that might involve medication or face-to-face therapy, these programs are delivered entirely online, making them convenient and easy to use at home. Fatigue Program A is a fully automated intervention, meaning it can be accessed anytime without needing a live therapist. Fatigue Program B, while similar in its web-based design, serves as an active comparator, potentially offering different benefits or insights. These digital solutions could make fatigue management more personalized and flexible for those with multiple sclerosis.

What evidence suggests that this trial's online therapy programs could be effective for managing fatigue in multiple sclerosis?

Research has shown that online programs can help manage tiredness in people with multiple sclerosis (MS). This trial will compare two different online fatigue management programs, Fatigue Program A and Fatigue Program B, both added to Treatment as Usual. Studies suggest that telemedicine, including online therapy, offers a promising alternative to traditional methods for reducing MS-related tiredness. One study found that web-based programs improve symptoms like tiredness by providing easy-to-access and flexible support. Another small study showed that a self-guided online program for managing tiredness had positive results for people with MS. These findings suggest that online programs might be a helpful tool for managing MS tiredness. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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

Informed consent by person with MS

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

My fatigue levels are high according to a specific scale.

Exclusion Criteria

Unwilling or unable to consent

Refusal to saving, processing and forwarding of pseudonymized data

Concurrent participation in another interventional trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three arms: two arms receive an online fatigue management program in addition to usual MS treatment, and the third arm receives usual MS treatment alone

6 months

Online program access

Crossover/Extension

Participants in the usual MS treatment alone arm can choose one of the online programs for the final 6 months

6 months

Online program access

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Online Therapy for Fatigue

Trial Overview CAFE-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.

How Is the Trial Designed?

Group I: Fatigue Program A added to Treatment as Usual Experimental Treatment 1 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 Usual Active Control 1 Intervention

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

Group III: Treatment as Usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

Accelerated Cure Project for Multiple Sclerosis

Lead Sponsor

Trials

5

Recruited

30,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University Medical Center Goettingen

Collaborator

Trials

68

Recruited

35,800+

Charite University, Berlin, Germany

Collaborator

Trials

1,071

Recruited

3,739,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Published Research Related to This Trial

Amantadine has been shown to improve fatigue in multiple sclerosis patients, based on a systematic review of 11 clinical trials, indicating its potential as a treatment option.

The drug is generally well-tolerated with mild side effects, but further research with larger studies and standardized fatigue measurements is needed to confirm its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of amantadine for the treatment of fatigue in multiple sclerosis: a systematic review and meta-analysis. Perez, DQ., Espiritu, AI., Jamora, RDG.[2021]

A pilot randomized controlled trial involving 40 patients with Multiple Sclerosis demonstrated that the Internet-based cognitive behavior therapy program, MS Invigor8, significantly reduced fatigue severity and impact compared to standard care, with large treatment effects (d=1.19 for severity and d=1.02 for impact).

Participants in the MS Invigor8 group also experienced notable improvements in anxiety, depression, and overall quality of life, suggesting that this online intervention could be a clinically effective and cost-effective option for managing MS-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomised controlled trial of an Internet-based cognitive behavioural therapy self-management programme (MS Invigor8) for multiple sclerosis fatigue. Moss-Morris, R., McCrone, P., Yardley, L., et al.[2022]

Fatigue is the most common symptom reported by people with multiple sclerosis (MS) and significantly affects their quality of life, making its early detection and management crucial.

Rehabilitative interventions, particularly aerobic exercise, have shown positive effects on managing fatigue in MS, while medications like amantadine may offer some benefits, though their efficacy lacks strong evidence from randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue and multiple sclerosis. Béthoux, F.[2006]

The COMBO-MS trial is designed to compare the effectiveness of cognitive behavioral therapy (CBT), modafinil, and their combination in reducing fatigue in patients with multiple sclerosis (MS) over a 12-week period, involving random assignment of participants with significant fatigue.

The study aims to determine if combination therapy is more effective than either treatment alone and to explore how factors like depression, sleep disorders, and disease severity may influence treatment outcomes, which could lead to better management strategies for MS-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pragmatic trial of telephone-delivered cognitive behavioral-therapy, modafinil, and combination therapy of both for fatigue in multiple sclerosis: The design of the "COMBO-MS" trial. Kratz, AL., Alschuler, KN., Ehde, DM., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12270147/

Application of telemedicine in fatigue management for patients ... Telemedicine demonstrates potential as a viable alternative to conventional rehabilitation for managing MS-related fatigue, particularly through multimodal ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0327563

Application of telemedicine in fatigue management for patients ... Telemedicine demonstrates potential as a viable alternative to conventional rehabilitation for managing MS-related fatigue.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10585158/

Management of multiple sclerosis fatigue in the digital age Virtual reality and e-Health are viable and modern tools to both assess and treat fatigue, with a variety of applications and adaptability to patient needs.

4. link.springer.com link.springer.com/article/10.1007/s41347-025-00488-0

Meta-analysis of the Efficacy of Web-Based Psychological ... The aim of this research was to perform a systematic review and meta-analysis on the efficacy of web-based psychological interventions to improve these symptoms

5. research.aota.org research.aota.org/ajot/article/70/4_Supplement_1/7011520289p1/6811/Utility-and-Outcomes-of-a-Digitally-Delivered-Self

Utility and Outcomes of a Digitally Delivered, Self-Guided ... This multimethod, time-series pilot study evaluated a digitally delivered, self-guided fatigue management resource for people with multiple sclerosis. Results ...

6. withpower.com withpower.com/trial/phase-fatigue-5-2024-584ba

Online Therapy for Fatigue in Multiple Sclerosis (CAFE-MS ... Research shows that internet-based cognitive behavioral therapy (CBT) can effectively reduce fatigue in people with multiple sclerosis. A study found that an ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01198977

Telehealth-Based Exercise Program to Treat Fatigue in MS ... A structured online system, such as ClinicalTrials.gov, that provides the public with access to summary information about ongoing and completed clinical studies ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034824008010

Tele-exercise in multiple sclerosis: Systematic review and ... This systematic review and meta-analysis examined the effects of tele-exercise on fatigue, depression, QoL, and mental and physical health among MS patients.