Actively Recruiting

Phase Not Applicable
Age: 30Years - 55Years
All Genders
NCT05380050

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

Led by VA Office of Research and Development · Updated on 2025-10-21

63

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Veterans who served in OIF, OEF, or OND and have both mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) by VA & DoD criteria
  • The most recent mTBI happened at least 6 months before joining the study
  • Attention deficit score at least 1.5 standard deviations below the mean on the RBANS attention index
  • Have a family member or friend willing to complete a questionnaire
  • Have access to a home computer or smartphone with internet
Not Eligible

You will not qualify if you...

  • History of learning disability before injury
  • History of severe psychiatric illness requiring hospitalization
  • Neurological diseases unrelated to traumatic brain injury, such as seizure disorder or stroke
  • Score below 90 on the National Adult Reading Test (NART)
  • Failed validity testing on the Test of Memory Malingering (TOMM)
  • Reported alcohol or substance abuse in the past year
  • Currently involved in litigation related to injury
  • Recent medication changes for seizures, depression, or memory problems
  • Enrolled in other cognitive therapy that cannot be stopped
  • Does not speak English fluently
  • Not able to provide informed consent or understand study risks
  • Uncontrolled acute medical or psychiatric conditions making participation unsafe, including active suicidal or homicidal intent, psychosis, or urgent symptoms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States, 32608-1135

Actively Recruiting

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Research Team

M

Margaret H McCallum

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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