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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · May 12, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new combined training program can help veterans who have both mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD). Many veterans face challenges with thinking and attention because of these conditions, which can make everyday tasks difficult. The study will compare two ways of delivering this training: in-person visits and online sessions through telehealth. Researchers hope to find out which method is more effective in improving attention, problem-solving skills, and overall daily functioning.

To participate in the trial, veterans need to have served in certain recent military operations and have a diagnosis of both mTBI and PTSD. They should have had their most recent brain injury at least six months ago and struggle with attention. Participants must also have access to a computer or smartphone with internet. However, those with a history of serious learning disabilities, certain neurological issues, or those currently involved in other cognitive therapies will not be eligible. If you or someone you know fits these criteria, this study could offer valuable support and possibly improve their quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Gainesville, Florida, United States

Gainesville, Florida, United States

Patients applied

0 patients applied

Trial Officials

Julia K. Waid-Ebbs, PhD

Principal Investigator

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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