Status:
COMPLETED
Combining Attention and Metacognitive Training to Improve Goal Directed Behavior in Veterans With TBI
Lead Sponsor:
VA Office of Research and Development
Conditions:
Mild Traumatic Brain Injury
Eligibility:
All Genders
19-55 years
Phase:
NA
Brief Summary
Veterans with mild traumatic brain injury continue to deal with symptoms that interfere with their ability to engage in productive activities. In combination with other psychosocial difficulties, impa...
Detailed Description
This is a pilot study to test the effect of GMT plus Attention Training for Veterans with chronic mTBI. The research design is a parallel study with randomization to treatment or control with test adm...
Eligibility Criteria
Inclusion
- Veterans with a diagnosis mTBI between the ages of 18 to 55, that demonstrate a deficit in attention, pass effort testing and have not changed psychotropic medication within the past two weeks.
- all Veterans who have served in OIF-OEF-OND with single- (at least brief loss of conscious) or multiple (with at least alteration of consciousness) mild traumatic brain injury (mTBI) during deployment, who seek services at North Florida/South Georgia Veterans Health System (NF-VHS).
- TBI must have suffered their injury at least 6 months prior to study enrollment and currently be in stable neurological condition.
- age range 19-55 years to reduce the impact of aging on treatment improvement.
- Attention deficit of 1.5 SD below the mean of the RBANS attention index. This will ensure that participants have an objective deficit attention.
- Family member or friend that is willing to complete the BRIEF-A (BRIEF-A guidelines of face to face interaction with the participant at least twice a week) at all measurement time points.
- 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 either the Test of Memory Malingering (TOMM),). Score of 45 or less on TOMM Trial 2 or retention trial.
- Reported alcohol or substance abuse within the past year
- Reported involvement in current litigation
- 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.
- Psychotropic drugs that have changed within the past two-weeks that would impact performance during assessment.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04044456
Start Date
January 1 2019
End Date
December 31 2022
Last Update
August 30 2024
Active Locations (1)
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1
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608