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

ConditionTraumatic Brain Injury

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCraig Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

6 months post-mild to severe TBI based on the Ohio State University TBI Identification Method (OSU TBI-ID)]

Fatigue Severity Scale score ≥4

Community dwelling

Able to operate a computer (independently or assisted)

Disqualifiers

Self-reported history of neurodegenerative condition or schizophrenia

No severe depression; PHQ8 score ≤ 10

Trial design

Design model

Parallel

Treatments tested in this trial

FACETS-TBI
Behavioral
FACETS-TBI (Fatigue: Applying Cognitive Behavioral and Energy Effectiveness Techniques to Lifestyle for Traumatic Brain Injury) is a remotely delivered, group-based fatigue self-management intervention designed for adults with traumatic brain injury (TBI) who experience persistent fatigue. FACETS-TBI was adapted from the evidence-based FACETS program originally developed for individuals with multiple sclerosis using a systematic intervention adaptation process that incorporated input from clinicians, researchers, and individuals with lived experience of TBI. The intervention is delivered in groups of up to eight participants through a secure videoconferencing platform. Participants attend six weekly sessions lasting approximately 60 to 90 minutes each. Sessions are facilitated by trained health professionals and combine education, guided discussion, cognitive behavioral techniques, practical fatigue management strategies, group activities, and between-session homework assignments. Par
Attention Control
Behavioral
The Attention Control intervention is a remotely delivered, group-based educational and support program designed to control for the non-specific effects of participation in a behavioral intervention, including facilitator attention, group interaction, social support, and time spent in sessions. The intervention is adapted from the Brain Health Group (BHG), a previously developed and validated educational support intervention for adults with traumatic brain injury (TBI). Participants attend six weekly group sessions lasting approximately 60 to 90 minutes each and delivered through a secure videoconferencing platform. Groups consist of up to eight participants and are facilitated by trained interventionists using a standardized manual and scripted materials. The intervention is dose-matched to FACETS-TBI, providing an equivalent number of sessions, duration of contact, and opportunities for discussion and peer interaction. Session content focuses on general health, wellness, and brain

Treatment groups

66 Participants

are divided into 2 treatment groups

Group A: FACETS-TBI Intervention ArmExperimental treatment 1 intervention

Group B: Attention Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

Feasibility of Participant Retention and Session Completion

Feasibility will be assessed through participant retention rates, session attendance, session duration, number of sessions completed, and reasons for missed or incomplete sessions. These measures will be used to evaluate the practicality of delivering FACETS-TBI and the Attention Control intervention in a remote group format and to inform the design of a future randomized controlled trial.

Time frame

During each intervention session (Weeks 1-6); post-intervention (approximately Week 6); and 12-week follow-up

Participant Understanding of Intervention Content

Participant understanding of intervention content will be rated by the interventionist following each session using a 3-point ordinal scale (1=minimal understanding, 2=some understanding, 3=good understanding). Independent raters will assess a subset of sessions to establish inter-rater reliability.

Time frame

After each intervention session (Weeks 1-6).

Pittsburgh Rehabilitation Participation Scale (PRPS)

Description: The Pittsburgh Rehabilitation Participation Scale is a clinician-rated measure of participant engagement, effort, and motivation during intervention sessions. Scores range from 1 to 6, with higher scores indicating greater participation and engagement.

Time frame

After each intervention session (Weeks 1-6).

Client Satisfaction Questionnaire (CSQ-8)

Description: The Client Satisfaction Questionnaire is an 8-item measure of satisfaction with services received. Total scores range from 8 to 32, with higher scores indicating greater satisfaction with the intervention.

Time frame

Immediately post-intervention (within 1 week of the final session).

Secondary outcomes

Modified Fatigue Impact Scale (mFIS)

Description: The Modified Fatigue Impact Scale assesses the impact of fatigue on physical, cognitive, and psychosocial functioning. The 21-item scale produces total scores ranging from 0 to 84, with higher scores indicating greater impact of fatigue on daily life.

Time frame

Baseline (within 1 week before Session 1), post-intervention (within 1 week of the final session), and 12-week follow-up.

PROMIS Fatigue Short Form 8a

Description: The PROMIS Fatigue Short Form 8a assesses participants' experience and perceived impact of fatigue during the previous 7 days. Scores are standardized as T-scores with higher scores indicating greater fatigue.

Time frame

Baseline, post-intervention, and 12-week follow-up.

Fatigue Severity Scale (FSS)

Description: The Fatigue Severity Scale is a 9-item self-report measure assessing the severity of fatigue and its effect on functioning. Scores range from 1 to 7, with higher scores indicating greater fatigue severity.

Time frame

Baseline, post-intervention, and 12-week follow-up.

Multiple Sclerosis Fatigue Self-Efficacy Scale (MS-FSE)

Description: The Multiple Sclerosis Fatigue Self-Efficacy Scale measures an individual's confidence in their ability to effectively manage fatigue and its effects on daily life. Higher scores indicate greater fatigue-related self-efficacy.

Time frame

Baseline, post-intervention, and 12-week follow-up.

Other outcomes

Narrative Evaluation of Intervention Interview (NEII)

Description: The Narrative Evaluation of Intervention Interview is a semi-structured qualitative interview consisting of open-ended questions designed to explore how participants perceive, understand, experience, and feel about FACETS-TBI. Interview data will be analyzed to identify themes related to intervention acceptability, perceived benefits, barriers, and recommendations for future refinement.

Time frame

Immediately post-intervention (within 1 week of completion of the final intervention session).

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Craig Hospital

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov

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