| City: |
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West Haven |
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State:
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CT |
| Zip Code: |
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06516 |
| Conditions: |
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Post-Traumatic Stress Disorder |
| Purpose: |
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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.
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| Study summary: |
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1. 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.
2. 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.
3. 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.
4. Findings: This is a new study and there are no findings to date.
5. 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.
6. 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. |
| Criteria: |
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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 |
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| Study is available at: |
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VA Connecticut Health Care System (West Haven)
West Haven, CT 06516
United States
Primary Contact:
Tammy K Rowe, MS
Email: Tammy.Rowe2@va.gov
Phone: 203-932-5711
Secondary Contact:
Tammy K Rowe, MS
Email: Tammy.Rowe2@va.gov
Phone: (203) 932-5711 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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