NCT Number: NCT07190365
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).
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Palo Alto, California, 94304-1207, United States
Location status: Recruiting
Aman Kumar
CONTACT
650-493-5000 ext. 68200
Geoffrey W Goodale, BS
CONTACT
Tatjana Novakovic-Agopian, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Goal-Oriented Attentional Self-regulation training involves ten 2-hour sessions of group-based telehealth training, three individual 1-hour telehealth training sessions, and approximately 20 hours of home practice. It is conducted in a small group format.
The EDU TH training is an active control training matched with GOALS TH for therapist time, homework load, and participation in a group. It involves ten 2-hour telehealth sessions of group-based training, three individual 1-hour telehealth training sessions, and approximately 20 hours of home practice.
Time frame: 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.
Time frame: 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
Time frame: 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.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
Goal-oriented Rehabilitation of Executive Functioning Using Video-telehealth to Improve Community Reintegration for Veterans With Chronic TBI and Cognitive Difficulties
Acronym: GOALS TH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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