Neural Correlates of Cognitive Rehabilitation in Post-Traumatic Stress Disorder (PTSD)
|ClinicalTrials.gov Identifier: NCT00928941|
Recruitment Status : Terminated (The PI has left the project and the VA, as of 3/2011)
First Posted : June 26, 2009
Last Update Posted : December 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder||Behavioral: cognitive training Behavioral: video game||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Neural Correlates of Cognitive Rehabilitation in PTSD|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Experimental: Arm 1
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.
Behavioral: cognitive training
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.
Active Comparator: Arm 2
A computer game control condition will be implemented for 3-4 training exercises a week for 40 hours.
Behavioral: video game
An active control condition (computer game without increasing difficulty) will be implemented for at least 3-4 hours a week for 40 hours.
- neuropsychological test data [ Time Frame: post-training and 3 month follow up ]
- MRI data [ Time Frame: post-training and 3 month follow up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928941
|United States, Connecticut|
|VA Connecticut Healthcare System West Haven Campus, West Haven, CT|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Kristen Wrocklage, PhD||VA Connecticut Healthcare System West Haven Campus, West Haven, CT|