Goal-oriented Telehealth Rehabilitation of Executive Functioning for Veterans With Chronic TBI

Not Applicable

Not yet recruiting

• Conditions: Veteran; Mild to Moderate Traumatic Brain Injury; Cognitive Rehabilitation

• Registration Number: NCT07190365
• Lead Sponsor: VA Office of Research and Development

Brief Summary

Provision of interventions that address cognitive and emotional problems faced by Veterans with history of TBI pursuing community reintegration is an important concern for VA. Using telerehabilitation, the current project will help determine whether goal-directed training of attentional control functions via personally relevant activities will improve community integration for Veterans with history of TBI and cognitive difficulties. Findings may guide rehabilitation training towards providing services to maximize success in attaining complex functional goals in which Veterans can engage in skill strengthening 'where they are' (any location).

Detailed Description

Traumatic brain injury (TBI) and comorbid conditions are prevalent in post-9/11 Veterans Chronic sequela of TBI can be highly debilitating due to deficits in the cognitive control processes, including attention, executive functions, and memory. Deficits in these cognitive control functions have been linked with difficulties in community reintegration, educational and occupational functioning, and are some of leading long-term disability causes among Veterans. As Veterans transition from military to community, many are interested in continuing to serve on the home front, with success in community, school, and work being essential to this goal.

At present, there are no validated evidence-based executive function tele-rehabilitation interventions to support community reintegration for Veterans with chronic TBI/Polytrauma. This study aims to increase access and availability of evidence-based, in-person administered cognitive rehabilitation training for Veterans with chronic TBI interested in improving their community integration. The adaptations include: 1) video telehealth delivery, and 2) focus on Veteran-chosen community integration goals,.

The objectives of this study are to investigate the feasibility and acceptability, as well as short (immediately post training), and longer-term (6 months post training) effectiveness of video telehealth cognitive rehabilitation training in 80 Veterans with history of chronic mild to moderate TBI and cognitive difficulties who are interested in improving their community integration. In a randomized, controlled intervention study, 80 Veterans with a history of mild to moderate TBI and residual cognitive difficulties will participate in telehealth GOALS and/or Brain Health Education - EDU interventions matched for time and intensity. Both groups will participate in pre and post training measurements at baseline and post training. Long-term follow-up will be at 6 months. Pre- and post-intervention and long term measurements will include performance on untrained: neuro-cognitive tests assessing targeted and non-targeted cognitive domains, individually defined goal attainment, and self-report measures of emotional regulation and daily functioning.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-05
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Study Start: 2026-01-05
• Primary Completion: 2030-01-04
• Study Completion: 2030-01-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• History of mild to moderate TBI > 6 months ago
• Cognitive difficulties affecting daily functioning
• Age 18-65
• Veteran
• At least 12th grade education or equivalent * Interested in improving community reintegration

Exclusion Criteria

• Amnesic/Severe memory problems
• Active Substance Abuse/Dependence
• Medical condition that may affect mental status/disrupt study participation
• Active psychotropic medication changes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neurocognitive performance -Overall Attention and Executive Function (AEF) Z score	Baseline, 10 week (post training), 6 month	Performance on neurocognitive composite measure of attention and executive function post intervention vs control training will be assessed with Overall Attention and Executive Function (AEF) domain composite Z Score (calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching). AEF Z score range is -3 to +3; higher score = better outcome.

Secondary Outcome Measures

Name	Time	Method
Functional outcomes - Mayo Portland Adaptability Inventory (MPAI) T score	Baseline, 10 week (post training), 6 month	Performance on self-report measure of functional performance in daily life post intervention vs control training will be assessed with May Portland Adaptability Inventory (MPAI)- Total Score. MPAI Total T Score range is 20-80; higher score =worse outcome
Emotional regulation- Profile of Mood States (POMS) Z score	baseline, 10 week (post training), 6 month follow up	Performance on self report measures of emotional regulation post intervention vs control training Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance (TMD) Z Score. POMS Total Mood disturbance Z score range is -3 to +3; higher score = better outcome.

Trial Locations

Locations (1)

VA Palo Alto Health Care System, Palo Alto, CA; 🇺🇸 Palo Alto, California, United States