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 — BEHAVIORAL
    GMT 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 — BEHAVIORAL
    BHW 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 Training
    Goal 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 Training
    Goal 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 Workshop
    Brain 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

Locations (1)

FacilityCityStateZIPSite coordinators
North Florida/South Georgia Veterans Health System, Gainesville, FLGainesvilleFlorida32608-1135
Julia K Waid-Ebbs, PhD
(352) 376-1611
Julia K. Waid-Ebbs, PhD (PRINCIPAL_INVESTIGATOR)

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