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Adaptation and Feasibility Testing of a Fatigue Intervention in Adults With TBI

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Collaborators expanded, about 5 words
  2. Eligibility criteria shortened, about 3 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn whether FACETS-TBI (Fatigue: Applying Cognitive Behavioral and Energy Effectiveness Techniques to Lifestyle), a remote fatigue self-management program, is feasible and acceptable for adults with traumatic brain injury (TBI) who experience persistent fatigue. The study will also explore whether FACETS-TBI may improve fatigue and participation in daily life. The main questions it aims to answer are: Is FACETS-TBI feasible to deliver and acceptable to participants compared with an attention control program? Does FACETS-TBI improve fatigue severity, fatigue impact, fatigue-related self-efficacy, and participation in daily activities compared with an attention control program? How do participants perceive and experience FACETS-TBI? Researchers will compare FACETS-TBI to an attention control program that provides education and discussion about healthy lifestyle topics after TBI but does not include fatigue management strategies. Participants will: Be randomly assigned to receive either FACETS-TBI or the attention control program. Attend six weekly remote group sessions lasting approximately 60 to 90 minutes each. Complete questionnaires before the intervention, immediately after the intervention, and 12 weeks after completing the intervention. Provide information about fatigue, fatigue self-management, and participation in everyday activities. Participate in a one-on-one interview after the intervention (FACETS-TBI group only) to discuss their experiences and provide feedback about the program.
Trial Details
NCT Number NCT07798245
Lead Sponsor Craig Hospital
Collaborators: Congressionally Directed Medical Research Programs
Conditions
(from sponsor)		 Traumatic Brain Injury
Related terms Brain Injuries, Traumatic
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov