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Factorial Optimization Trial to Test Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue
Recruiting
Factorial Optimization Randomized Controlled Trial to Test The Effects of Cognitive Behavioral Therapy Components For Multiple Sclerosis Fatigue
Who can join
Ages 18 and older · All sexes
Full eligibility 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)
About the study
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.
What is being tested
- 4-session Relaxation Training (behavioral)
- 4-session Behavioral Activation (behavioral)
- 4-session Cognitive Therapy (behavioral)
Sponsor: University of Washington · Participants: 112 · Started: Jan 10, 2025
Contact the study team
- Lindsey Knowles, PhD · Phone: 206-744-9640
- Dawn Ehde, PhD · Phone: 206-744-2811
Official record on ClinicalTrials.gov — NCT06809192
Locations in the U.S.
| Washington | Multiple Sclerosis Center at UW Medical Center - Northwest, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.