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临床试验/NCT07798245
NCT07798245尚未招募不适用

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

Craig Hospital0 个研究点目标入组 66 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
主要终点
Feasibility of Participant Retention and Session Completion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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

干预措施: FACETS-TBI (Behavioral)

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.

干预措施: Attention Control (Behavioral)

结局指标

主要结局

Feasibility of Participant Retention and Session Completion

时间窗: 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.

Participant Understanding of Intervention Content

时间窗: 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.

Pittsburgh Rehabilitation Participation Scale (PRPS)

时间窗: 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.

Client Satisfaction Questionnaire (CSQ-8)

时间窗: 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.

Intervention Fidelity

时间窗: 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.

次要结局

  • Participation Assessment with Recombined Tools-Objective (PART-O)(Baseline, post-intervention, and 12-week follow-up.)
  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

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