Testing cognitive behavioral therapy components for fatigue in multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.