Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD

Recruiting now · Not applicable

Conditions studied: Brain Injury, Cognition, PTSD, Intervention

In brief

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 facts

Study ID

NCT05380050

Run by

VA Office of Research and Development

People needed

63

Starts

2022-11-01

Expected to finish

2026-10-31

Last updated by the study team

2025-10-21

Who can join

Age: 30 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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