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

September 1, 2026 updated by: Craig Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Post-traumatic brain injury fatigue (PTBIF) is one of the most common and disabling long-term consequences of traumatic brain injury (TBI). Individuals with TBI frequently identify fatigue as their most challenging symptom, reporting that it substantially affects daily functioning, social participation, emotional well-being, and overall quality of life. PTBIF is often persistent, difficult to manage, and can remain problematic for years following injury. Fatigue after TBI is associated with cognitive difficulties such as reduced attention and slower information processing, as well as emotional concerns including depression, anxiety, and pain. Despite its prevalence and impact, effective fatigue management options for people with TBI remain limited.

Research in other chronic health conditions suggests that cognitive behavioral approaches are among the most effective interventions for managing fatigue because they teach practical self-management skills and help individuals identify and modify behaviors, thoughts, and routines that may contribute to fatigue. However, most existing fatigue management programs have been developed and tested in populations such as individuals with multiple sclerosis and cancer, with relatively few interventions specifically designed for people with TBI. In addition, many individuals with TBI face significant barriers to accessing behavioral health services, including transportation challenges, financial limitations, limited availability of specialized providers, and geographic distance from rehabilitation programs.

To address these challenges, this study focuses on FACETS-TBI (Fatigue: Applying Cognitive Behavioral and Energy Effectiveness Techniques to Lifestyle for Traumatic Brain Injury), an adaptation of the original FACETS program developed for individuals with multiple sclerosis. FACETS is an evidence-based fatigue management intervention that combines cognitive behavioral strategies with practical energy conservation and self-management techniques. The program was adapted specifically for adults with TBI through a systematic and stakeholder-informed adaptation process guided by the ADAPT framework. The adaptation incorporated input from researchers, clinicians, individuals living with TBI, and other key stakeholders to ensure that the content is relevant, acceptable, and responsive to the unique experiences of post-traumatic brain injury fatigue.

The purpose of this study is to evaluate the feasibility of delivering FACETS-TBI remotely to adults with TBI who experience significant fatigue and to generate preliminary data that will inform the development of a future large-scale randomized controlled trial. The study will assess participant engagement, retention, session attendance, understanding of intervention content, satisfaction with participation, and overall acceptability of the intervention. The study will also provide preliminary information regarding potential changes in fatigue-related outcomes, fatigue self-management confidence, and participation in everyday activities and community life.

FACETS-TBI is delivered remotely in a group format and is designed to support the development of practical fatigue management skills that participants can apply in their daily lives. The intervention addresses topics such as understanding fatigue, identifying contributing factors, balancing activity and rest, improving sleep and recovery practices, managing stress, recognizing unhelpful thinking patterns, developing effective coping strategies, and creating sustainable plans for long-term fatigue management. The program emphasizes participant involvement through facilitated discussions, structured activities, guided reflection, and between-session practice assignments. Participants are encouraged to apply newly learned strategies in real-world settings and reflect on their experiences throughout the program.

To support interpretation of the feasibility and preliminary outcome findings, the study includes an attention control program designed to account for the non-specific effects of group participation, facilitator attention, intervention dose, and social interaction. The attention control program is adapted from the Brain Health Group, an educational support intervention previously used with adults with TBI. Participants in the attention control program receive the same frequency and duration of group sessions as participants in FACETS-TBI and engage in structured discussions about general health and wellness topics relevant to life after TBI, such as memory, attention, emotional well-being, and healthy lifestyle behaviors. The attention control curriculum intentionally excludes fatigue management content and does not include the key cognitive behavioral and self-management strategies incorporated into FACETS-TBI. By providing a comparable group experience without the intervention's hypothesized active ingredients, the attention control program will help researchers distinguish the specific effects of FACETS-TBI from improvements that may result from receiving attention, support, education, or participation in a group-based program.

The study also seeks to better understand participants' experiences with the intervention. Participants who complete FACETS-TBI will provide feedback regarding the program's content, delivery, usefulness, and perceived impact. These perspectives will be used to identify strengths of the intervention, determine areas for improvement, and guide future refinements to the program before testing in a larger trial.

Data collected during the study will include participant-reported measures related to fatigue, fatigue impact on daily life, fatigue severity, confidence in managing fatigue, and participation in social and community activities. Additional information regarding participant engagement, intervention delivery, treatment fidelity, and satisfaction will be collected to evaluate the practicality of implementing FACETS-TBI in a remote rehabilitation setting. Qualitative interviews will provide further insight into participants' perceptions of the intervention and recommendations for future development.

By evaluating the feasibility, acceptability, and preliminary effects of FACETS-TBI, this study aims to advance the development of accessible, evidence-based interventions for individuals living with post-traumatic brain injury fatigue. Findings from this work will inform the design of a larger clinical trial and may ultimately contribute to expanding rehabilitation options for both civilian and military populations affected by TBI.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
    • English fluency

  • 18 years old

    • Capacity to self-consent
    • No severe major depression; PHQ8 score ≤20

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FACETS-TBI Intervention Arm

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

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
Active Comparator: Attention Control Arm

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Participant Retention and Session Completion
Time Frame: During each intervention session (Weeks 1-6); post-intervention (approximately Week 6); and 12-week follow-up
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
Time Frame: After each intervention session (Weeks 1-6).
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)
Time Frame: After each intervention session (Weeks 1-6).
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)
Time Frame: Immediately post-intervention (within 1 week of the final session).
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
Time Frame: During intervention delivery (random sample of approximately 20% of sessions throughout Weeks 1-6).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Fatigue Impact Scale (mFIS)
Time Frame: Baseline (within 1 week before Session 1), post-intervention (within 1 week of the final session), and 12-week follow-up.
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.
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
Time Frame: Baseline, post-intervention, and 12-week follow-up.
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.
Baseline, post-intervention, and 12-week follow-up.
Fatigue Severity Scale (FSS)
Time Frame: Baseline, post-intervention, and 12-week follow-up.
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.
Baseline, post-intervention, and 12-week follow-up.
Multiple Sclerosis Fatigue Self-Efficacy Scale (MS-FSE)
Time Frame: Baseline, post-intervention, and 12-week follow-up.
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.
Baseline, post-intervention, and 12-week follow-up.
Participation Assessment with Recombined Tools-Objective (PART-O)
Time Frame: Baseline, post-intervention, and 12-week follow-up.
Description: The Participation Assessment with Recombined Tools-Objective measures participation in community, social, and productive activities following traumatic brain injury. Higher scores indicate greater participation in society.
Baseline, post-intervention, and 12-week follow-up.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narrative Evaluation of Intervention Interview (NEII)
Time Frame: Immediately post-intervention (within 1 week of completion of the final intervention session).
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.
Immediately post-intervention (within 1 week of completion of the final intervention session).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Craig Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT9425-24-1-1058 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

only IPD used in the results publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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