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Post-Deployment Afghanistan/Iraq Trauma Related Inventory of Traits (PATRIOT): Phase 1 (Feasibility Study) (PATRIOT)

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ClinicalTrials.gov Identifier: NCT01153529
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

The long-term goal of this research project is to identify genes that contribute to or guard against developing posttraumatic stress disorder (PTSD) and to better understand how genes and life experiences work together to impact PTSD. Inherited traits are passed down from one generation to the next in genes. Genes contain molecules called DNA, which contain the information that determines our characteristics and carries instructions for constructing and operating our body. Most human diseases have an inherited element. In addition, we, the investigators, hope to learn about how genes and the other materials we find in participants' blood relate to other illnesses and behaviors.

The goal of the feasibility project covered by this application is to test the possibility of conducting research on a large number of veterans in order to look at the association between genes and PTSD. We are inviting 1,000 OEF/OIF veterans to participate, of these, we are anticipating approximately 250 veterans who have served in Afghanistan and/or Iraq to participate in this study. Although 250 participants is our target enrollment, we plan to enroll all veterans included in our initial mailings who desire to participate. We do not anticipate this to exceed 500 individuals. This phase of the study is expected to last about one year. Specific aims are: 1. evaluation of sampling methods and participation rates; 2. field testing of assessment batteries including reliability and validity; and 3. evaluation of the proposed DNA collection and storage procedures.

Condition or disease

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 250 participants
Time Perspective: Retrospective
Official Title: CSP #575 - Post-Deployment Afghanistan/Iraq Trauma Related Inventory of Traits (PATRIOT): Phase 1 (Feasibility Study)
Study Start Date : September 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012

Group 1
OEF/OIF Veterans

Primary Outcome Measures :
  1. Response Rate

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
OEF/OIF Veterans

Inclusion Criteria:

1.Participant must have served in support of Operation Enduring Freedom or Operation Iraqi Freedom (OEF/OIF) as this is a study relevant to these veterans

Exclusion Criteria:

  1. Participants who were unconscious for more than 30 minutes. This may impact event recall
  2. Lifetime diagnosis and/or treatment of bipolar disorder or schizophrenia. (NOTE: PTSD in the context of these severe psychiatric disorders is likely to be different from PTSD outside of that context. Excluding subjects with severe psychiatric disorders will increase the homogeneity of the sample and our power to detect genetic effects.)
  3. Refusal to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153529

United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
Study Chair: Murray B Stein, MD MPH VA San Diego Healthcare System, San Diego

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01153529     History of Changes
Other Study ID Numbers: 575
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014

Keywords provided by VA Office of Research and Development: