112 Participants Needed

Cognitive Behavioral Therapy for Multiple Sclerosis Fatigue

LK
DE
Overseen ByDawn Ehde, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized controlled factorial trial will examine whether and how relaxation training, behavioral activation, and cognitive therapy improve fatigue and functioning in fatigued adults living with multiple sclerosis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have changed your disease modifying medications in the past three months to be eligible.

Is Cognitive Behavioral Therapy safe for treating fatigue in Multiple Sclerosis?

The research does not specifically address safety concerns, but Cognitive Behavioral Therapy (CBT) is generally considered safe for treating various conditions, including fatigue in Multiple Sclerosis. It is a non-invasive therapy that focuses on changing negative thought patterns and behaviors.12345

How does the treatment Cognitive Behavioral Therapy for Multiple Sclerosis Fatigue differ from other treatments?

This treatment is unique because it combines Behavioral Activation, Cognitive Therapy, and Relaxation Training to specifically target the thoughts and behaviors that perpetuate fatigue in multiple sclerosis, rather than just addressing physical symptoms. Unlike some medications, this approach has shown effectiveness in reducing fatigue by changing how patients think and behave, and it can be delivered face-to-face or through an internet-based program, making it more accessible.12346

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Multiple Sclerosis Fatigue?

Research shows that cognitive behavioral therapy (CBT) is effective in reducing fatigue in multiple sclerosis (MS) patients. A study found that CBT was more effective than relaxation training in decreasing MS fatigue, and other studies confirm CBT's positive impact on fatigue management.12347

Who Is on the Research Team?

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Lindsey Knowles, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults with multiple sclerosis who experience fatigue. It's not specified, but typically participants should be in stable health aside from their MS and fatigue symptoms.

Inclusion Criteria

I have been diagnosed with multiple sclerosis.
Able to fluently converse and read in English
Able to comply with study procedures and complete self-report measures
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Exclusion Criteria

I have had an MS flare-up in the last 30 days.
Current suicidal ideation with intent or plan as indicated by a score of ≥1 on the Patient Health Questionnaire-9 suicide item and further assessment via the Columbia Suicide Severity Rating Scale (although individuals with suicidal ideation but no intent or plan will be considered eligible)
Currently participating in another research study that could impact fatigue such as intervention studies targeting mood, energy management, exercise/physical activity, and diet (although participants can be screened for eligibility again once they have completed the other research study)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telehealth CBT components including Relaxation Training, Behavioral Activation, and Cognitive Therapy for multiple sclerosis fatigue

8-16 weeks
4 sessions per component, delivered via phone or videoconference

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Patient-reported outcome measures collected at 3-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • Behavioral Activation
  • Cognitive Therapy
  • Relaxation Training
Trial Overview The study tests three different short therapies: cognitive therapy to change thought patterns, relaxation training to reduce stress, and behavioral activation to increase engagement in activities. The goal is to see which helps most with MS-related fatigue.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Active Control
Group I: Relaxation Training, Behavioral Activation, and Cognitive TherapyExperimental Treatment3 Interventions
Group II: Relaxation Training onlyExperimental Treatment1 Intervention
Group III: Relaxation Training and Cognitive TherapyExperimental Treatment2 Interventions
Group IV: Relaxation Training and Behavioral ActivationExperimental Treatment2 Interventions
Group V: Cognitive Therapy onlyExperimental Treatment1 Intervention
Group VI: Behavioral Activation onlyExperimental Treatment1 Intervention
Group VII: Behavioral Activation and Cognitive TherapyExperimental Treatment2 Interventions
Group VIII: No TreatmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy (CBT) significantly improved cognitive and behavioral factors related to fatigue in multiple sclerosis patients compared to Relaxation Training (RT), with 70 participants involved in the study.
Changes in negative beliefs about fatigue were found to mediate the reduction in fatigue severity, indicating that addressing these beliefs is crucial for the effectiveness of CBT, independent of mood improvements.
Which cognitions and behaviours mediate the positive effect of cognitive behavioural therapy on fatigue in patients with multiple sclerosis?Knoop, H., van Kessel, K., Moss-Morris, R.[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.
Fatigue and multiple sclerosis.Béthoux, F.[2006]
Blended cognitive behavioural therapy (CBT), which combines online modules with therapist support, was found to be non-inferior to traditional face-to-face CBT in reducing fatigue severity in 166 patients with multiple sclerosis, demonstrating its effectiveness as an alternative treatment.
The blended approach not only maintained treatment efficacy but also significantly reduced the time therapists spent with patients, making it a more efficient option without any reported harm related to the treatment.
Blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis: A non-inferiority RCT.de Gier, M., Beckerman, H., Twisk, J., et al.[2023]

Citations

Which cognitions and behaviours mediate the positive effect of cognitive behavioural therapy on fatigue in patients with multiple sclerosis? [2022]
Fatigue and multiple sclerosis. [2006]
Blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis: A non-inferiority RCT. [2023]
Cognitive behavioural therapy for MS-related fatigue explained: A longitudinal mediation analysis. [2019]
The Berlin Treatment Algorithm: recommendations for tailored innovative therapeutic strategies for multiple sclerosis-related fatigue. [2020]
A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue. [2022]
A pilot randomised controlled trial of an Internet-based cognitive behavioural therapy self-management programme (MS Invigor8) for multiple sclerosis fatigue. [2022]
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