Testing cognitive behavioral therapy components for fatigue in multiple sclerosis
Factorial Optimization Randomized Controlled Trial to Test The Effects of Cognitive Behavioral Therapy Components For Multiple Sclerosis Fatigue
This study is testing whether different types of therapy can help adults with multiple sclerosis feel less tired and improve their daily functioning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06809192 on ClinicalTrials.gov |
What this trial studies
This randomized controlled factorial trial aims to evaluate the effectiveness of relaxation training, behavioral activation, and cognitive therapy in reducing fatigue and improving functioning in adults with multiple sclerosis. Fatigue is a prevalent and debilitating symptom for many individuals with MS, and this study seeks to optimize cognitive behavioral therapy (CBT) components to enhance accessibility and effectiveness. Participants will engage in telehealth sessions focusing on these therapeutic components, which are designed to address the cognitive, emotional, and behavioral aspects of fatigue. The trial employs a balanced factorial design to assess the main and interactive effects of these interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of multiple sclerosis and significant fatigue as measured by the Fatigue Severity Scale.
Not a fit: Patients who have experienced a recent MS relapse or have made changes to their disease-modifying medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and accessible treatment option for managing fatigue in patients with multiple sclerosis.
How similar studies have performed: Other studies have shown promise in using cognitive behavioral therapy for managing fatigue in chronic conditions, suggesting potential success for this approach in multiple sclerosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Confirmed MS diagnosis of any subtype 2. Score of 4 or higher on the Fatigue Severity Scale 3. Able to fluently converse and read in English 4. 18 years of age or older 5. Able to comply with study procedures and complete self-report measures 6. Willing to have intervention sessions audiotaped for fidelity coding 7. Has experienced fatigue for 3 or more months Exclusion Criteria: 1. MS relapse within last 30 days (although participants will be considered eligible after the 30-day window) 2. Change in disease modifying medications (DMTs) in the prior three months (although participants will be considered eligible after the 3-month window) 3. 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) 4. Currently engaged in psychotherapy for fatigue 5. 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)
Where this trial is running
Seattle, Washington
- Multiple Sclerosis Center at UW Medical Center - Northwest — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Lindsey Knowles, PhD — University of Washington
- Study coordinator: Lindsey Knowles, PhD
- Email: lmknow@uw.edu
- Phone: 206-744-9640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.