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Neural Correlates of Cognitive Rehabilitation in Post-Traumatic Stress Disorder (PTSD)

Primary Purpose

Post-Traumatic Stress Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive training
video game
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

A cognitive training program (Posit Science) or an active control (video game) will be implemented for at least 3-4 hours a week for 40 training units.

A computer game control condition will be implemented for 3-4 training exercises a week for 40 hours.

Outcomes

Primary Outcome Measures

neuropsychological test data

Secondary Outcome Measures

MRI data

Full Information

First Posted
June 22, 2009
Last Updated
December 9, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00928941
Brief Title
Neural Correlates of Cognitive Rehabilitation in Post-Traumatic Stress Disorder (PTSD)
Official Title
Neural Correlates of Cognitive Rehabilitation in PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
The PI has left the project and the VA, as of 3/2011
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Post Traumatic Stress Disorder (PTSD) is an emotional disorder that can also lead to problems with attention and memory. Cognitive training has been successfully used to improve attention and processing speed in other patient populations as well as healthy elderly. The purpose of this study is to examine how effective cognitive training will be in Veterans with PTSD.
Detailed Description
Objective(s) Post Traumatic Stress Disorder (PTSD) has been established as relatively common in a significant number of OEF/OIF Veterans (Vasterling & Brailey, 2005; Hoge et al., 2008). Attention deficits, which are prominent in PTSD, may be due to difficulty sustaining attention over time and encoding or getting information into storage which leads to reduced attention and memory scores on neuropsychological measures. Disruptions in attention are common in many types of neurological and psychiatric disorders. Deficient attentional skills may negatively affect cognitive performance in other areas (e.g., memory, planning) and thereby reduce effectiveness navigating daily life tasks as well as decrease the Veteran's life satisfaction after returning home. The origin of the attention impairment may be amenable to sophisticated remediation approaches using a "bottom up, neuroscience based" visual training program (i.e., Posit Science, Inc. cognitive rehabilitation program), which has been successful in improving neurocognitive function in healthy older adults (e.g., Mahncke et al., 2006) and patients with Schizophrenia (e.g., Bell at al., 2008). By engaging Veterans with PTSD in targeted remediation, it is expected that both behavioral (seen in neuropsychological test gains) and neural activity (e.g., BOLD response through fMRI) will reflect the improvement and this may be linked to improved outcomes in daily functioning. Research Design: 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 [cogrem x video game] and within subject variable of time tested (pre-training, post-training, 3 month follow up). There will be 40 participants enrolled in the following groups of 10 each: 1) +PTSD/cogrem, 2) +PTSD/video game, 3) -PTSD/cogrem, and 4) -PTSD/video game. PTSD status is determined by a diagnosis of PTSD identified through a clinical interview for DSM-IV diagnostic criteria for PTSD. The active treatment is cognitive training. Veterans in this group will receive the Posit Science (Mahncke et al., 2006) visual cognitive remediation paradigm of 40 hours of training. The control treatment is a video game designed by Nintendo for the DS handheld system, which intended to improve mental functioning called Brain Age (Nintendo, Inc.) which will be played for 40 hours. Groups will be compared on the difference scores for neuropsychological, neurobehavioral and neuroimaging data to see if there is a benefit in cognitive training and if that benefit is greater in the group with PTSD. Methodology: Forty outpatient Veterans will be enrolled. All individuals will receive a neurobehavioral interview, neuropsychological testing and neuroimaging at the baseline visit, post training and at follow-up visits. After the baseline visit, each volunteer will be randomized to one of two conditions. Findings: This is a new study and there are no findings to date. Clinical Relationships: This study will examine the effects of a standard cognitive rehabilitation program with OEF/OIF veterans who have cognitive deficits due to PTSD. This project will impact veterans' healthcare by identifying cognitive problems in PTSD and will test the ability of a rehabilitation program to remediate those problems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
A cognitive training program (Posit Science) or an active control (video game) will be implemented for at least 3-4 hours a week for 40 training units.
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
A computer game control condition will be implemented for 3-4 training exercises a week for 40 hours.
Intervention Type
Behavioral
Intervention Name(s)
cognitive training
Intervention Description
A cognitive training program (Posit Science) or an active control (video game) will be implemented for at least 3-4 hours a week for 40 training units/hours.
Intervention Type
Behavioral
Intervention Name(s)
video game
Intervention Description
An active control condition (computer game without increasing difficulty) will be implemented for at least 3-4 hours a week for 40 hours.
Primary Outcome Measure Information:
Title
neuropsychological test data
Time Frame
post-training and 3 month follow up
Secondary Outcome Measure Information:
Title
MRI data
Time Frame
post-training and 3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Wrocklage, PhD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

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Neural Correlates of Cognitive Rehabilitation in Post-Traumatic Stress Disorder (PTSD)

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