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

NCT07798245 | Not Yet Recruiting

• 2 other identifiers: HT9425-24-1-1058CDMRP-TP230023
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

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

• Intervention Fidelity

  Description: Intervention fidelity will be assessed using a study-specific Fidelity Checklist evaluating adherence to intervention protocols and facilitator competence. Fidelity assessments will determine whether intervention content was delivered as intended and whether contamination between study groups was prevented.

  During intervention delivery (random sample of approximately 20% of sessions throughout Weeks 1-6).

Secondary Outcomes (5)

• Modified Fatigue Impact Scale (mFIS)

  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

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

• Fatigue Severity Scale (FSS)

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

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

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

• Participation Assessment with Recombined Tools-Objective (PART-O)

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

Other Outcomes (1)

• Narrative Evaluation of Intervention Interview (NEII)

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

Study Arms (2)

FACETS-TBI Intervention Arm

EXPERIMENTAL

Participants assigned to this arm receive the adapted FACETS-TBI program, a remote group-based fatigue management intervention that combines: Cognitive behavioral strategies Energy conservation and fatigue management techniques Stress management Sleep and recovery strategies Goal setting and self-management skill development Participants attend six weekly sessions lasting approximately 60 to 90 minutes each and complete related homework activities

Behavioral: FACETS-TBI

Attention Control Arm

ACTIVE COMPARATOR

Participants assigned to this arm receive a dose-matched remote group program designed to control for: Facilitator attention Group interaction Time spent in sessions General educational exposure The sessions focus on general brain health and healthy lifestyle topics after TBI (e.g., memory, attention, emotional well-being) but do not include fatigue management content or the cognitive behavioral techniques that are considered the active ingredients of FACETS-TBI.

Behavioral: Attention Control

Interventions

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

FACETS-TBI Intervention Arm

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

Attention Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• English fluency
• years old
• Capacity to self-consent
• No severe major depression; PHQ8 score ≤20

You may not qualify if:

• Self-reported history of neurodegenerative condition or schizophrenia
• No severe depression; PHQ8 score ≤ 10

Sponsors & Collaborators

• Craig Hospital: lead
• Congressionally Directed Medical Research Programs: collaborator

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MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Candice Osborne, PhD

CONTACT

2147949773; cosborne@craighospital.org

Mackenzie Peckham, MS

CONTACT

mpeckham@craighospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share