What this study is
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's being tested
- 4-session Relaxation Training
Intervention · BEHAVIORAL
A 4-session telehealth Relaxation Training intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis and the cognitive behavioral model of multiple sclerosis fatigue, b) treatment rationale, c) didactic and experiential training in relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, and autogenic relaxation, and d) goal setting and problem-solving barriers to integrate relaxation practices into daily routine.
- 4-session Behavioral Activation
Intervention · BEHAVIORAL
A 4-session telehealth Behavioral Activation intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis, the cognitive behavioral model of multiple sclerosis fatigue, and self-monitoring activity and energy, b) treatment rationale, c) identification of values/priorities to guide activities, d) activity planning, e) goal setting and problem-solving barriers to engaging in activities.
- 4-session Cognitive Therapy
Intervention · BEHAVIORAL
A 4-session telehealth Cognitive Therapy intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis, the cognitive behavioral model of multiple sclerosis fatigue, self-monitoring thoughts, and core beliefs, b) treatment rationale, c) labeling thoughts as helpful, unhelpful, or neutral, d) using distraction to cope with unhelpful thoughts, e) challenging and changing unhelpful thoughts, f) problem-solving barriers to coping with or changing unhelpful thoughts.
Study details
- Official title
- Factorial Optimization Randomized Controlled Trial to Test The Effects of Cognitive Behavioral Therapy Components For Multiple Sclerosis Fatigue
- Sponsor
- University of Washington
- Conditions
- Multiple Sclerosis
- Enrolling
- 112 people
- Starts
- 2025-01-10
- Est. completion
- 2027-03-31
- Design
- Open-label, randomized, factorial
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Confirmed MS diagnosis of any subtype
- Score of 4 or higher on the Fatigue Severity Scale
- Able to fluently converse and read in English
- 18 years of age or older
- Able to comply with study procedures and complete self-report measures
- Willing to have intervention sessions audiotaped for fidelity coding
- Has experienced fatigue for 3 or more months
You can't join if
- MS relapse within last 30 days (although participants will be considered eligible after the 30-day window)
- Change in disease modifying medications (DMTs) in the prior three months (although participants will be considered eligible after the 3-month window)
- 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)
- Currently engaged in psychotherapy for fatigue
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMultiple Sclerosis Center at UW Medical Center - Northwest
Seattle, Washington, United States
- Study Coordinator · Contact206-598-0501cbt-ms-fatigue@uw.edu
- Lindsey Knowles, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Washington
Study ID STUDY00021168
Principal investigator
Lindsey Knowles, PhD
University of Washington
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.