Prospective Case Series to Refine Standalone Cognitive Behavioral Therapy Components for Multiple… (NCT05848323) | Clinical Trial Compass
CompletedNot Applicable
Prospective Case Series to Refine Standalone Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue
United States21 participantsStarted 2023-10-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
Exclusion criteria
✕. 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
✕. 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)
What they're measuring
1
Intervention Acceptability
Timeframe: Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).
2
Intervention Appropriateness
Timeframe: Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).
3
Intervention Feasibility
Timeframe: Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).
✕. 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).