NCT06809192 Factorial Optimization Trial to Test Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue
| NCT ID | NCT06809192 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2025-01-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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)
Contact & Investigator
Lindsey Knowles, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06809192 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06809192 currently recruiting?
Yes, NCT06809192 is actively recruiting participants. Contact the research team at lmknow@uw.edu for enrollment information.
Where is the NCT06809192 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT06809192 clinical trial?
NCT06809192 is sponsored by University of Washington. The principal investigator is Lindsey Knowles, PhD at University of Washington. The trial plans to enroll 112 participants.
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