View Clinical Trial (Medical Research Study)
Enhancing Cognitive Function and Reintegration in Iraq and Afghanistan Veterans With PTSD Using Computer-Based Cognitive Training
| City: |
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San Francisco |
| State: |
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California |
| Zip Code: |
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94121 |
| Conditions: |
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Post-traumatic Stress Disorder |
| Purpose: |
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The purpose of this study is to investigate a new method for improving cognitive function in
Iraq and Afghanistan veterans who meet criteria for PTSD. If eligible, subjects will be
invited to participate in a trial to test a new computer-based intervention that may help
veterans improve cognitive function.
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| Study Summary: |
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Studies are showing that veterans who return from deployment in Iraq or Afghanistan with or
without traumatic brain injury (TBI) may have problems with certain cognitive/brain
functions such as memory, concentration, decision-making and regulating their emotions.
Problems with cognitive function have also been associated with PTSD. This intervention will
occur in the privacy of one's home, so this study requires that participants have a laptop
or desktop computer and have access to an internet connection. Participants will be asked to
work on computer-based mental exercises for 1 hour a day, 5 days per week for 8 weeks for a
total of 40 hours. In the main part of the study, there will be four, 2-hour study
assessment visits at the SFVAMC: two visits before starting the computer training sessions
and a third visit following the completion of all 40 computer training sessions (at 3
months). Three months after completing the computer training sessions, participants will
visit the SFVAMC once more for a final assessment. This assessment will last approximately 2
hours. In total, participation will last approximately six months.
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| Criteria: |
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Inclusion Criteria:
- Confirmed OEF and/or OIF/OND military service
- Male and female veterans, ages 18 to 50 years with a minimum of 12 years of education
- History of a prior positive PTSD screen or diagnosis either by SFVAMC study referral
or self-report
- No prior history of moderate to severe traumatic brain injury (TBI); but a history of
mild TBI is not grounds for exclusion
- Able and willing to travel to SFVAMC
- Able and willing to perform daily home-based computer exercises for 8 weeks.
- Meet threshold criteria for current full or sub-syndromal PTSD by DSM-IV criteria.
Veterans meeting criteria for only sub-syndromal PTSD must also have a total CAPS
score >30.
- Report ≥ 1 moderate or severe cognitive symptom(s) on the NSI that interfere(s) with
daily function including moderate to severe poor concentration, forgetfulness,
difficulty making decisions and slowed thinking.
- Because PTSD is a highly comorbid condition, eligible participants may have other
comorbid stable neuropsychiatric disorders, including depression or a history of a
mild traumatic brain injury.
Exclusion Criteria:
- Poor English comprehension and fluency
- Not owning a computer or laptop or having access to an internet connection
- Unstable medical condition, injury or disability, including moderate to severe TBI
(by self-report) and hearing impairment
- Current (or past 60 days) evidence-based PTSD or cognitive remediation therapy; in
contrast, stable supportive therapy for PTSD and/or other mental disorders, such as
group therapy or on stable psychoactive medication (> 30 days) will be acceptable.
- Drug and alcohol dependence and other unstable serious mental illness (psychotic
disorders and bipolar disorder) (assessed using the SCID)
- Regular stable drug users (e.g. occasional marijuana smokers) who do not meet
diagnostic criteria for drug dependence must agree to refrain from using drugs 24
hours prior to their cognitive training sessions.
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| NCT ID: |
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NCT01552278 |
| Primary Contact: |
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Principal Investigator
Karen H Seal, M.D.
University of California, San Francisco
Lindsay K Mayott, B.A.
Phone: (415)221-4810 ext. 3944
Email: lindsay.mayott@va.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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San Francisco, California 94121
United States
Lindsay K Mayott, B.A.
Phone: 415-221-4810
Email: lindsay.mayott@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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