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Recruiting NCT06809192

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

Trial Parameters

Condition Multiple Sclerosis
Sponsor University of Washington
Study Type INTERVENTIONAL
Phase N/A
Enrollment 112
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-01-10
Completion 2026-12-31
Interventions
4-session Relaxation Training4-session Behavioral Activation4-session Cognitive Therapy

Brief Summary

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.

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 psychothera

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