NCT05848323Completed
Prospective Case Series to Refine Standalone Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
This prospective case series will use mixed methods to examine the feasibility, acceptability, and initial effects of three telehealth cognitive behavioral therapy components (relaxation training, behavioral activation, cognitive therapy) for fatigue in people with multiple sclerosis.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 27 Apr 2023
- Start date
- 30 Oct 2023
- Primary completion date
- 25 Sept 2024
- Lead sponsor
- University of Washington
- Diseases
- Multiple sclerosis
- NCT number
- NCT05848323
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 30 Oct 2023 to the primary completion date, 25 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in disease modifying medications in the prior three months assessed via self-report (although participants will be considered eligible after the 3-month window)
- History of MS relapse within the last 30 days prior to screening assessed via self-report (although participants will be considered eligible after the 30-day window)
Other illness
- Score greater than 7 on the Patient Determined Disease Steps Scale
- Has significant cognitive impairment as indicated by 1 or more errors on the 6-item Cognitive Screener
Other
- Current suicidal ideation with intent or plan as indicated by a score of 1 or higher on the Patient Health Questionnaire-9 suicide item and further assessment with 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 assessed via self-report
- Current pregnancy (although participants will be considered eligible when they are no longer pregnant)
- 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 once they have completed the other research study).
Who the study is looking for
- MS diagnosis of any subtype per chart review
- Score 4 or higher on the Fatigue Severity Scale
- Presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for 3 or more months
- Are able to comply with study procedures and complete measures independently assessed via self-report
- All genders
- 18 years of age or older
- Able to read and speak English
- Are willing to maintain current fatigue treatment regimen for duration of study (although individuals who want to make a change to their fatigue treatment regimen will be considered eligible 3 months after making that change)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multiple Sclerosis Center at UW Medical Center - Northwest Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.