Online Therapy for Fatigue in Multiple Sclerosis

(CAFE-MS Trial)

Recruiting at 3 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

Trial Summary

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 data supports the effectiveness of the treatment Online Therapy for Fatigue in Multiple Sclerosis?

Research shows that internet-based cognitive behavioral therapy (CBT) can effectively reduce fatigue in people with multiple sclerosis. A study found that an online CBT program, MS Invigor8, led to significant improvements in fatigue severity and impact, as well as anxiety and depression, suggesting that online therapy can be a helpful treatment for managing MS-related fatigue. ^{1 2 3 4 5}

Is online therapy for fatigue in multiple sclerosis safe?

The research does not provide specific safety data for online therapy for fatigue in multiple sclerosis, but cognitive behavioral therapy (CBT), which is often used in online formats, is generally considered safe for managing fatigue in MS. ^{1 6 7 8 9}

How does the online therapy for fatigue in multiple sclerosis differ from other treatments?

This online therapy is unique because it is a self-guided, interactive program based on cognitive behavioral therapy (CBT) and mindfulness, designed to be accessed over the internet. Unlike traditional face-to-face CBT, it offers flexibility and convenience, allowing patients to manage their fatigue at their own pace without the need for travel. ^{1 2 3 10 11}

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.

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.

Exclusion Criteria

Unwilling or unable to consent

Refusal to saving, processing and forwarding of pseudonymized data

Concurrent participation in another interventional trial

Timeline

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

Treatment Details

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.

Participant Groups

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: Treatment as Usual Active Control 1 Intervention

Group III: 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.

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Testing non-inferiority of blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis and the effectiveness of blended booster sessions aimed at improving long-term outcome following both therapies: study protocol for two observer-blinded randomized clinical trials. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating occupational performance coaching to support fatigue management for people with multiple sclerosis: A feasibility study. [2022]

3. England 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. [2022]

4. United States 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. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Remote Monitoring in Evaluating Fatigue in Multiple Sclerosis: A Review. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Fatigue in multiple sclerosis: A UK MS-register based study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of amantadine for the treatment of fatigue in multiple sclerosis: a systematic review and meta-analysis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Modafinil for the treatment of multiple sclerosis-related fatigue. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Fatigue and multiple sclerosis. [2006]

10. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis. [2019]

11. England pubmed.ncbi.nlm.nih.gov

A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol. [2020]