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

NCT01153529 | Completed DMC

• 1 other identifier: 575
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

• Response Rate

Study Arms (1)

Group 1

OEF/OIF Veterans

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

OEF/OIF Veterans

You may qualify if:

• 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

You may not qualify if:

• Participants who were unconscious for more than 30 minutes. This may impact event recall
• 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.)
• Refusal to participate.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Murray B Stein, MD MPH

  VA San Diego Healthcare System, San Diego

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 19, 2014

Record last verified: 2014-05

Locations

US (1)