Comparing telehealth and in-person training for veterans with brain injuries and PTSD
Comparing the Effectiveness of Telehealth to In-person Delivery of a Combined Metacognitive and Attention Training in Veterans With mTBI/PTSD
This study tests whether veterans with brain injuries and PTSD can benefit just as much from online training as they do from in-person training to improve their attention and problem-solving skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 30 Years to 55 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05380050 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a combined intervention of Goal Management Training and attention training in veterans diagnosed with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD). It aims to determine whether this intervention can be delivered effectively via telehealth compared to traditional in-person methods. The study will assess improvements in cognitive functions such as attention and executive function, which are often impaired in this population. Preliminary results suggest that this combined approach may enhance problem-solving and functional task performance.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans who have served in OIF-OEF-OND and have a diagnosis of both mTBI and PTSD, with specific cognitive impairments.
Not a fit: Patients with pre-existing learning disabilities or severe psychiatric conditions that require hospitalization may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive functioning and daily living skills for veterans suffering from mTBI and PTSD.
How similar studies have performed: Previous studies combining Goal Management Training with attention training have shown promising results, although this specific approach in veterans with mTBI and PTSD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veterans who have served in OIF-OEF-OND and have been diagnosed with both a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on the joint criteria of the Veterans' Affairs and Department of Defense (VA \& DoD). * Latest mTBI occurred at least 6 months prior to study enrollment. * Attention deficit of 1.5 SD below the mean of the RBANS attention index. * Family member or friend that is willing to complete a questionnaire. * Access to a home computer, or smartphone with internet access. Exclusion Criteria: * History of pre-morbid learning disability. * History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization. * Neurological disease unrelated to TBI (seizure disorder, stroke). * Score \< 90 on National Adult Reading Test (NART). * Failure of validity testing on the Test of Memory Malingering (TOMM). * Reported alcohol or substance abuse within the past year. * Reported involvement in current litigation related to injury. * Recent change of medications for seizures, depression, or memory. * Currently enrolled in other cognitive therapy that cannot be discontinued. * Does not speak English fluently. * Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation). * Uncontrolled, acute medical or psychiatric condition as indicated by the participant or observed by the research team member that would make it unsafe to participate in the research activities, i.e. precautions for active homicidal/suicidal intent, active psychosis, or acute symptoms requiring immediate medical attention.
Where this trial is running
Gainesville, Florida
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Julia K. Waid-Ebbs, PhD — North Florida/South Georgia Veterans Health System, Gainesville, FL
- Study coordinator: Margaret H McCallum
- Email: Margaret.McCallum@va.gov
- Phone: (352) 376-1611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.