NCT05380050 Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD
| NCT ID | NCT05380050 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 63 participants in total. It began in 2022-11-01 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.
Eligibility 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.
Contact & Investigator
Julia K. Waid-Ebbs, PhD
PRINCIPAL INVESTIGATOR
North Florida/South Georgia Veterans Health System, Gainesville, FL
Frequently Asked Questions
Who can join the NCT05380050 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 55 Years, studying Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05380050 currently recruiting?
Yes, NCT05380050 is actively recruiting participants. Contact the research team at Margaret.McCallum@va.gov for enrollment information.
Where is the NCT05380050 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT05380050 clinical trial?
NCT05380050 is sponsored by VA Office of Research and Development. The principal investigator is Julia K. Waid-Ebbs, PhD at North Florida/South Georgia Veterans Health System, Gainesville, FL. The trial plans to enroll 63 participants.