Testing CBT Components for Multiple Sclerosis Fatigue

This study is looking at different parts of Cognitive Behavioral Therapy (CBT) to see how they help with fatigue in people with multiple sclerosis (MS). We are testing three specific approaches: Relaxation Training, Behavioral Activation, and Cognitive Therapy. Each of these involves 4 telehealth (online or phone) sessions. We want to understand which of these components, or combinations, are most effective at reducing fatigue and improving your ability to participate in social activities. You might be able to join if you are 18 or older, have a confirmed MS diagnosis, experience significant fatigue, and can speak and read English. The study will enroll 112 participants to help us learn more about the best ways to treat MS fatigue.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a randomized controlled trial, which means participants are assigned to different treatment groups by chance. The study plans to enroll 112 participants.
What's involved
You would participate in 4 telehealth intervention sessions. You would also complete online surveys at the beginning of the study, right after your last treatment session, and three months later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three months after their treatment sessions.

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NCT06809192

Factorial Optimization Trial to Test Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue

Recruiting
NAAges 18+InterventionalTreatment
University of Washington
~112 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:4-session Relaxation Training4-session Behavioral Activation4-session Cognitive Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Modified Fatigue Impact Scale
Measured over Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month follow-up.
+1 more outcome measured
Multiple Sclerosis
1 sites across 1 states
Washington1
  • Lindsey Knowles, PhD · PRINCIPAL_INVESTIGATOR · University of Washington

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  • Modified Fatigue Impact ScaleCollected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month follow-up.

    This is a 21-item self-report questionnaire assessing fatigue-related symptoms in the previous four weeks via 5-point Likert-type scale. A higher score indicates greater fatigue.

  • PROMIS Short Form - Ability to Participate in Social Roles and ActivitiesCollected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month follow-up.

    This 8-item short form is a self-report questionnaire that assesses the perceived ability to perform one's usual social roles and activities via 5-point Likert-type scale. A lower score indicates lower ability to participate in social roles and activities.