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

Description

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.

Conditions

Multiple Sclerosis

Study Overview

Study Details

Study overview

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.

Factorial Optimization Randomized Controlled Trial to Test the Effects of Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue

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

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Seattle

Multiple Sclerosis Center at UW Medical Center - Northwest, Seattle, Washington, United States, 98133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

Lindsey Knowles, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

2028-07