Actively Recruiting
Comparing the Effectiveness of Telehealth to In-person Delivery of a Combined Metacognitive and Attention 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
N/A
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) often face challenges with attention, executive function, and cognitive tasks that affect their daily lives. This research aims to evaluate and compare the effects of a combined strategy called Goal Management Training plus computerized attention training (GMT+ATT) delivered either in-person or through telehealth. The study will assess improvements in executive function, attention, and real-world tasks in these Veterans. Participants will be randomly assigned to one of three groups: in-person GMT+ATT, telehealth GMT+ATT, or a control group receiving the Brain Health Workshop (BHW). Both GMT and attention training involve weekly 2-hour sessions over 10 weeks, with homework assignments between sessions. The in-person group attends sessions at the clinic, while the telehealth group participates via video connection. The BHW control includes brain education and National Geographic movie sessions for the same duration. Throughout the study, Veterans will undergo evaluations before treatment, immediately after, and at 6-month and 1-year follow-ups. Assessments include tests of executive function, attention, real-life task performance like grocery shopping, and quality of life measures. Researchers will track cognitive changes, treatment response, and safety, aiming to determine if telehealth delivery is as effective as in-person therapy over the total study period.
CONDITIONS
Brief Title
Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans who served in OIF, OEF, or OND and have diagnosed mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on VA and DoD criteria
- Most recent mTBI occurred at least 6 months before enrollment
- Attention deficit scoring 1.5 standard deviations below average on the RBANS attention index
- Have a family member or friend willing to complete a questionnaire
- Access to a home computer or smartphone with internet
You will not qualify if you...
- History of learning disability before injury
- Severe psychiatric diagnosis requiring inpatient hospitalization
- Neurological diseases unrelated to TBI 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)
- Alcohol or substance abuse reported within the past year
- Involvement in current litigation related to injury
- Recent medication changes for seizures, depression, or memory
- Currently in other cognitive therapy that cannot be stopped
- Does not speak English fluently
- Not able to provide informed consent or understand study risks and expectations
- Uncontrolled acute medical or psychiatric conditions making participation unsafe, including active homicidal/suicidal intent or psychosis requiring immediate care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants receive 10 weeks of combined metacognitive and attention training delivered either in-person or via telehealth, or participate in a brain health educational workshop as a control. Sessions occur weekly and include group and one-on-one training with additional homework.
Weekly visits for 10 weeks (in-person or telehealth)
Duration - Up to 1 year post-treatment
Participants are assessed for treatment effects at post-treatment, 6 months, and 1 year after treatment completion to evaluate cognitive and functional outcomes.
3 visits (in-person or telehealth) at post-treatment, 6 months, and 1 year
Trial Site Locations
Total: 1 location
1
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135
Actively Recruiting
Research Team
M
Margaret H McCallum
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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