GAME Veterans With PTSD Using Computer-Based Cognitive Training (NCT01087775) | Clinical Trial Compass
CompletedNot Applicable
GAME Veterans With PTSD Using Computer-Based Cognitive Training
United States25 participantsStarted 2010-04
Plain-language summary
The investigators hypothesis are as follows:
H1a: OEF/OIF veterans with PTSD who perform cognitive training (CT) will demonstrate greater objective improvements on standard (untrained) neurocognitive measures, with the largest gains in verbal memory, learning and sustained attention.
H1b: Objective cognitive improvements in CT participants will be sustained at three months post-intervention, suggesting persistence of neuroplasticity-based cognitive training benefits.
H2a: OEF/OIF veterans with PTSD who perform CT will report greater improvements in cognitive function.
H2b: OEF/OIF veterans with PTSD who perform CT will demonstrate improved social and occupational functioning and quality of life.
H2c: OEF/OIF veterans with PTSD who perform CT will demonstrate greater improvements in community reintegration.
Who can participate
Age range
18 Years – 40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Confirmed OEF and/or OIF military service
. Male veterans, ages 18 to 40 years with 12 to 16 years of education
. History of a prior positive PTSD screen or diagnosis either by SFVAMC study referral or self-report'
. Able and willing to travel to SFVAMC
. Able and willing to perform daily home-based computer exercises for three months.
. The Clinician-Administered PTSD screen (CAPS) and the Mini International Neuropsychiatric Interview (MINI) 29 to assess for Diagnostic and Statistical Manual (DSM)-IV Axis I psychiatric disorders
. The VA TBI second-level screen \[TBI event history and Neurobehavioral Symptom Inventory (NSI) for cognitive symptoms\].30
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention)
. Meet threshold criteria for current full or sub-syndromal PTSD by DSM-IV criteria 31
Exclusion criteria
. Poor English comprehension and fluency
. Unstable medical condition, injury or disability, including moderate to severe TBI (by self-report) and hearing impairment
. Current (or past 60 day) evidence-based PTSD or cognitive remediation therapy; in contrast, stable supportive therapy for PTSD and/or other mental disorders, such as group therapy or on stable psychoactive medication (\> 30 days) will be acceptable.
. Drug and alcohol dependence and other unstable serious mental illness (e.g. psychosis) (assessed using the MINI)