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

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

Interventions

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

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

Sponsors & Collaborators

• Craig Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2027-10-01

Completion

2028-01-01