West Haven, Connecticut 06516

  • Traumatic Brain Injury

Purpose:

Posttraumatic stress disorder (PTSD) is commonly associated with deficits in attention and memory skills. As such, these deficits may negatively affect performance in other cognitive domains (e.g., memory, executive functions), leading individuals with PTSD to experience difficulties in everyday functioning and reductions in quality of life. Investigators therefore aim to examine whether U.S. Veterans with PTSD will benefit from engagement in targeted cognitive remediation by measuring longitudinal change in neuropsychological performance, neural activity, and clinical outcomes. The longitudinal research design for this project will be a three factor mixed factorial design with between subject factors of PTSD (+PTSD x -PTSD) and cognitive remediation (learning-based cognitive training [LBCT] x non-learning training [NLT]) and the within subject variable of time tested (pre-training, post-training, 3 month follow-up). Forty participants will be enrolled in four groups of 10 each: 1) +PTSD/LBCT, 2) +PTSD/NLT, 3) -PTSD/LBCT, and 4) -PTSD/NLT. All groups will receive 40 hours of computerized training. Outcomes will be measured at baseline (i.e., pre-treatment), after an average of 8 weeks of treatment, and at 6 months post-treatment. The active treatment is the Posit Science visual cognitive remediation paradigm (i.e., InSight), while the control treatment will utilize games face valid for cognitive training. This study will examine the effects of a standardized cognitive rehabilitation program on neurocognitive functioning and brain functional activation in OEF/OIF veterans with PTSD. The proposed study addresses several issues important to advancing the care of Veterans with PTSD. This project will comprehensively assess potential cognitive problems experienced by individuals with PTSD, which may benefit clinicians and researchers focused on the treatment of PTSD. It will also examine whether a sophisticated rehabilitation program that is rooted in clinical neuroscience (but also commercially available) can remediate these problems, and what structural and functional brain changes are associated with this remediation. Finally, it will examine whether changes associated with cognitive training persist over a longer-term follow-up period.


Criteria:

Inclusion Criteria: - OEF/OIF Veteran, - meets DSM-IV criteria for PTSD, - control group does not meet criteria for PTSD Exclusion Criteria: - prior history of significant head injury (LOC > 30 minutes) or other neurological disorder (e.g., stroke, seizure, multiple sclerosis), learning disability or confirmed diagnosis of ADHD, - contraindication to MR imaging, failed malingering tests during testing, or a history of severe mental illness (i.e., Schizophrenia, Bipolar Disorder) individuals will be excluded if in the 30 days prior to the initial interview if they: - do not have stable housing (i.e., staying in same residence), - have medication changes or have had a psychiatric hospitalization, - participants who meet DSM-IV criteria for substance dependence will be excluded from the study, - individuals will also receive urine toxicology and Breathalyzer testing as the first procedure on the evaluation day (pre and post treatment and at 3 month follow up); participants who test positive for alcohol or recent substance use (e.g., methamphetamine) or report significant levels of drug or alcohol use if they are unable to abstain from substance use at three consecutive visits - veterans who are currently engaged in therapy treatment for PTSD


NCT ID:

NCT01584349


Primary Contact:

Principal Investigator
Brian Schweinsburg, Ph.D.
VA Connecticut Healthcare System/ Yale University

Brian C Schweinsburg, Ph.D.
Phone: 203-932-5711 ext. 2525
Email: brian.schweinsburg@yale.edu


Backup Contact:

N/A


Location Contact:

West Haven, Connecticut 06516
United States

Brian C Schweinsburg, Ph.D.
Phone: 203-932-5711
Email: brian.schweinsburg@yale.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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