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

2026年9月3日 更新者: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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

66

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的: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

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

アクティブコンパレータ: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.

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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Feasibility of Participant Retention and Session Completion
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Modified Fatigue Impact Scale (mFIS)
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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.

その他の成果指標

結果測定
メジャーの説明
時間枠
Narrative Evaluation of Intervention Interview (NEII)
時間枠: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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2028年1月1日

試験登録日

最初に提出

2026年8月27日

QC基準を満たした最初の提出物

2026年8月27日

最初の投稿 (実際)

2026年9月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月9日

QC基準を満たした最後の更新が送信されました

2026年9月3日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • HT9425-24-1-1058 (Department of Defense)
  • CDMRP-TP230023 (その他の助成金/資金番号:Congressionally Directed Medical Research Programs (CDMRP))

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

only IPD used in the results publication

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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