Neural Correlates of Cognitive Rehabilitation in PTSD

Conditions

Posttraumatic Stress Disorder | Traumatic Brain Injury

Trial Phase

N/A

Trial Purpose and Description

Trial 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.



Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility 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
Sponsor:
VA Connecticut Healthcare System
Yale University
Dates:
May 2011
Last Updated:
February 12, 2013
Study HIC#:
1104008372

Clinicaltrials.gov ID: NCT01584349