CSP #566 - Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study
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Purpose
This is a research study examining health effects of the Iraq War, especially those effects involving mental health. This study is a follow-up to the Neurocognition Deployment Health Study (NDHS), also called "Prospective Assessment of Neurocognition in Future Gulf-deployed and Gulf-nondeployed Military Personnel: A Pilot Study." The specific purpose of this research study is to find out more about the longer lasting effects of war on mood and stress symptoms, thinking and reaction skills, and different aspects of day to day life, such as work and daily activities. Survey and test results from previous participation in the NDHS will be compared to the new information that will be obtained from participants as part of this study. We expect that a total of about 817 military personnel and military veterans will participate in the study. There are two parts to this study: (1) mail/internet/phone survey and (2) in-person assessment. We will invite all NDHS participants who deployed to Iraq to participate in the survey component. The survey component of the study involves being interviewed by phone about mood and stress symptoms and head injuries and completing written survey questions by either mail or on the internet that address basic personal history (such as age, military status, gender, combat injury history), mood, stress symptoms, and stressful experiences. The phone interview will take about 2 to 2.5 hours to complete. The questionnaire part will take about 20 to 30 minutes to complete, and can be completed either by mailing back completed questionnaires or by internet using a private, individual log-in/password combination. We will invite approximately 200 selected at random from the larger group of survey responders to take part in the in-person assessment. The in-person assessment involves taking a small subset of neuropsychological tasks. The tasks will be given on a computer or using paper and pencil. Participants will also be asked to complete questionnaires about work, daily activities, and health history, as well as basic health measures such as height, weight, blood pressure, heart rate, and waist size. Potential participants will be given the option of completing the in-person assessment at one of the two study sites (Seattle or Boston), or in a private setting in their community (e.g., a hotel small conference room). Altogether, this part of the study will take about 120 minutes to 140 minutes to complete.
| Condition |
|---|
|
Stress Disorders, Post-Traumatic |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | CSP #566 - Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study |
- PTSD diagnosis (current CAPS dx) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- PTSD threshold (PCL derived screening estimate) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Neuropsych performance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 817 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Group 1 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Surviving members of the NDHS cohort of 1595 participants
Inclusion Criteria:
- Deployment to Iraq with completed NDHS baseline assessments
Exclusion Criteria:
- non-deployed,
- sensory-motor or cognitive loss sufficiently profound to permit meaningful participation in the study
Contacts and Locations| Contact: Mihaela Aslan, PhD | (203) 932-5711 ext 5679 | mihaela.aslan@va.gov |
| Contact: Patricia Crutchfield | (203) 932-5711 ext 5854 | patricia.crutchfield@va.gov |
| United States, Connecticut | |
| CERC (VISN1, West Haven, CT) | Active, not recruiting |
| West Haven, Connecticut, United States, 06516 | |
| United States, Massachusetts | |
| VA Medical Center, Jamaica Plain Campus | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: Jennifer J Vasterling, PhD 857-364-6522 Jennifer.Vasterling@va.gov | |
| Contact: Christopher B Harte (857) 364-4022 Christopher.Harte@va.gov | |
| Study Chair: Jennifer J. Vasterling, PhD | |
| VA Medical Center, Jamaica Plain Campus | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: Heather Kapson, PhD 857-364-6322 heather.kapson@va.gov | |
| United States, Washington | |
| VA Puget Sound Health Care System, Seattle | Recruiting |
| Seattle, Washington, United States, 98108 | |
| Contact: Heidi Montoya-Perez, PhD 206-277-3563 heidi.montoya-perez@va.gov | |
| Study Chair: | Jennifer J. Vasterling, PhD | VA Medical Center, Jamaica Plain Campus |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00748995 History of Changes |
| Other Study ID Numbers: | 566 |
| Study First Received: | September 5, 2008 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013