Status:
RECRUITING
Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD
Lead Sponsor:
VA Office of Research and Development
Conditions:
Brain Injury
Cognition
Eligibility:
All Genders
30-55 years
Phase:
NA
Brief 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 ...
Detailed Description
Background. Over 70% of Veterans with mild traumatic brain injury (mTBI), seeking services at the Veterans' Health Administration, suffer from comorbid post-traumatic stress disorder (PTSD). These Vet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05380050
Start Date
November 1 2022
End Date
October 31 2026
Last Update
October 21 2025
Active Locations (1)
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1
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135