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Not Yet Recruiting NCT07798245

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

Conditions: Traumatic Brain Injury

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 66
Sponsor: Craig Hospital

Summary

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.

Eligibility Criteria

Inclusion Criteria: * (1) ≥ 6 months post-mild to severe TBI based on the Ohio State University TBI Identification Method (OSU TBI-ID)\]; (2) Fatigue Severity Scale score ≥4; (3) community dwelling; (4) able to operate a computer (independently or assisted); (5) English fluency; (6) ≥18 years old; (7) capacity to self-consent; (8) no severe major depression; PHQ8 score ≤20 Exclusion Criteria: * 1\) Self-reported history of neurodegenerative condition or schizophrenia 2) no severe depression; PHQ8 score ≤ 10

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07798245). StuddyBuddy aggregates publicly available trial information.