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CSP 566 - Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study
This study is not yet open for participant recruitment.
Verified by Department of Veterans Affairs, February 2009
First Received: September 5, 2008   Last Updated: February 12, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00748995
  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. Finally, participants will be made aware of the opportunity to be part of a substudy to "bank" genetic material for future scientific analysis directed toward identifying biomarkers associated with adaptive and non-adaptive reactions to war-zone stress


Condition
Stress Disorders, Post-Traumatic

MedlinePlus related topics: Post-Traumatic Stress Disorder Surgery
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort
Official Title: CSP 566 - Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PTSD diagnosis (current CAPS dx) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Saliva


Estimated Enrollment: 817
Study Start Date: April 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Surviving members of the NDHS cohort of 1595 participants

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748995

Contacts
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

Locations
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Investigators
Study Chair: Jennifer J. Vasterling, PhD VA Medical Center, Jamaica Plain Campus
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Vasterling, Jennifer - Study Chair )
Study ID Numbers: 566
Study First Received: September 5, 2008
Last Updated: February 12, 2009
ClinicalTrials.gov Identifier: NCT00748995     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 07, 2009