Comparing the Effectiveness of Telehealth to In-person Delivery of a Combined Metacognitive and Attention Training in Veterans With mTBI/PTSD

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL
RECRUITING
Gainesville
Contact Information
Primary
Margaret H McCallum
Margaret.McCallum@va.gov
(352) 376-1611
Backup
Yi Zhang, PhD
yizhang@ufl.edu
(352) 548-6000
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 63
Treatments
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.
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov

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