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Neural Correlates of Cognitive Rehabilitation in PTSD

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by VA Connecticut Healthcare System
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT01584349
First received: April 17, 2012
Last updated: February 12, 2013
Last verified: February 2013
  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.


Condition Intervention
Posttraumatic Stress Disorder
Traumatic Brain Injury
Behavioral: Adaptive Cognitive Training
Behavioral: Games of Cognitive Skill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Neural Correlates of Cognitive Rehabilitation in Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Change in Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [ Time Frame: Pre-treatment, after an average of 8 weeks of treatment, and 6 months post-treatment ] [ Designated as safety issue: No ]
    The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week.


Secondary Outcome Measures:
  • Change in Magnetic Resonance Imaging (MRI) data [ Time Frame: Pre-treatment, after an average of 8 weeks of treatment, and 6 months post-treatment ] [ Designated as safety issue: No ]
    MRI data consist of functional magnetic resonance imaging of parametric spatial working memory and sustained attention (i.e.., continuous performance task).

  • Change in Neuropsychological data [ Time Frame: Pre-treatment, after an average of 8 weeks of treatment, and 6 months post-treatment ] [ Designated as safety issue: No ]
    Neuropsychological evaluation provides primary outcome measurements from domains of attention and memory.


Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adaptive Learning Condition
Cognitive training stimuli (Posit Science, Inc. Insight) provided to participants on laptop computers.
Behavioral: Adaptive Cognitive Training
Duration of training is minimum of three hours per week until forty hours of training has been completed. Completion time is expected to be 4-10 weeks.
Other Name: Cognitive Training
Active Comparator: Face Valid Game Condition
Computer games that are face valid for improving cognitive functioning such as word puzzles, games of reaction time and planning as examples.
Behavioral: Games of Cognitive Skill
Duration of game playing is minimum of three hours per week until forty hours of training has been completed. Completion time is expected to be 4-10 weeks.
Other Name: Game Condition

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584349

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

Locations
United States, Connecticut
VA Connecticut Healthcare System, 151E Recruiting
West Haven, Connecticut, United States, 06516
Contact: Brian C Schweinsburg, Ph.D.    203-932-5711 ext 2525    brian.schweinsburg@yale.edu   
Sponsors and Collaborators
VA Connecticut Healthcare System
Yale University
Investigators
Principal Investigator: Brian Schweinsburg, Ph.D. VA Connecticut Healthcare System/ Yale University
  More Information

No publications provided

Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT01584349     History of Changes
Other Study ID Numbers: BS0002-01492
Study First Received: April 17, 2012
Last Updated: February 12, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Connecticut Healthcare System:
Cognitive Rehabilitation
Neuropsychology
Magnetic Resonance Imaging
PTSD
Mild Traumatic Brain Injury

Additional relevant MeSH terms:
Brain Injuries
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Mental Disorders
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014