RecruitingNot ApplicableNCT05380050

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

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


Sponsor

VA Office of Research and Development

Enrollment

63 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 30 YearsMax Age: 55 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria12

  • 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.

Interventions

BEHAVIORALGoal Management Training plus Attention Training

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.

BEHAVIORALBrain Health Workshop and National Geographic Movies

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.


Locations(1)

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

Gainesville, Florida, United States

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NCT05380050


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