Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT05380050
- Status
- Recruiting
Conditions
- Brain Injury
- Cognition
- Intervention
- PTSD
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- Goal Management Training plus Attention Training — BEHAVIORALGMT is a Power Point directed interactive group training to use a five point strategy to plan and execute complex tasks. Attention Training utilizes Brain HQ attention modules and individualized attention goals.
- Brain Health Workshop and National Geographic Movies — BEHAVIORALBHW is a Power Point directed interactive training to learn about the brain and cognitive components. National Geographic Movies, participants select movies to watch with the therapists and answers questions regarding the content.
Study Details
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.
Key Dates
- Start date
- Nov 1, 2022
- Status verified
- Oct 2025
- Primary completion
- Oct 30, 2026
- Completion
- Oct 31, 2026
Study Design
- Enrollment
- 63 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Inpatient GMT plus Attention TrainingGoal Management Training is a group metacognitive intervention to improve ability to complete complex task more effectively. 2-hour session are conducted in-person weekly over 10-weeks. A second weekly session includes Attention training which is conducted one-on-one with the therapist in the clinic. Participant completed 5-6 hours of homework between sessions.
- Experimental: Telehealth GMT plus Attention TrainingGoal Management Training is a group metacognitive intervention to improve ability to complete complex task more effectively. 2-hour session are conducted over the VA VideoConnect weekly over 10-weeks. A second weekly session includes Attention training which is conducted one-on-one with the therapist via VA VideoConnect. Participant completed 5-6 hours of homework between sessions
- Placebo Comparator: Brain Health WorkshopBrain Health Workshop includes educational information about the brain to control for GMT and National Geographic Movies is used as a control to equate time with therapist in Attention Training. Each session occurs weekly for 2-hours over 10-weeks.
Primary Outcome Measure
Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research [ Time Frame: pre-intervention, post, 6-month and 1-year follow-up ]
Central Contacts
- Margaret H McCallum(352) 376-1611
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida | 32608-1135 | Julia K. Waid-Ebbs, PhD (PRINCIPAL_INVESTIGATOR) |
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