Veteran Health Study

Depression Clinical Trial

Official title:

CSP #569 - A Twin Study of the Course and Consequences of PTSD in Vietnam Era Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175629
• Other study ID #: 569
• Status: Completed
• Phase: N/A
• First received: August 3, 2010
• Last updated: June 30, 2014
• Start date: January 2010
• Est. completion date: March 2013

Study information

• Verified date: June 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The purpose of The Veteran Health Study (CSP #569) is to better understand the mental and physical health of veterans as they get older. We are inviting approximately 10,000 members of the Vietnam Era Twin (VET) Registry to participate. As veterans approach their mid-sixties, it is important to understand the impact of wartime deployment on health and mental health outcomes nearly 40 years later.

The investigators will assess the prevalence of post-traumatic stress disorder (PTSD) and other mental and physical health conditions for Vietnam era veterans, and explore the relationship between PTSD and other conditions.

CSP #569 involves 3 phases of data collection. In Phase I, VET Registry members are invited to complete a paper and pencil questionnaire including items on physical and mental health, disability, health behaviors, demographic information and use of health care services. After completing Phase I, VET Registry members are invited to Phase II which involves a telephone interview about mental health. In Phase III, some of those who participated in Phase I will be invited to a sub-study confirming self-reported heart disease and diabetes using a provider survey.

Data collected for CSP #569 will be combined with existing VET Registry data. This will provide a rich picture of the health of Vietnam era veterans and the influence of PTSD on the lives of veterans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7568
• Est. completion date: March 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All twins who are currently active in the VET Registry will be invited to participate in CSP #569.

Exclusion Criteria:

• Unable or unwilling to provide informed consent

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Depression
• Diabetes
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Goldberg J, Magruder KM, Forsberg CW, Kazis LE, Ustün TB, Friedman MJ, Litz BT, Vaccarino V, Heagerty PJ, Gleason TC, Huang GD, Smith NL. The association of PTSD with physical and mental health functioning and disability (VA Cooperative Study #569: the co — View Citation

Magruder K, Yeager D, Goldberg J, Forsberg C, Litz B, Vaccarino V, Friedman M, Gleason T, Huang G, Smith N. Diagnostic performance of the PTSD checklist and the Vietnam Era Twin Registry PTSD scale. Epidemiol Psychiatr Sci. 2015 Oct;24(5):415-22. doi: 10. — View Citation

Vaccarino V, Goldberg J, Magruder KM, Forsberg CW, Friedman MJ, Litz BT, Heagerty PJ, Huang GD, Gleason TC, Smith NL. Posttraumatic stress disorder and incidence of type-2 diabetes: a prospective twin study. J Psychiatr Res. 2014 Sep;56:158-64. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the prevalence of lifetime and current psychiatric conditions including PTSD in Vietnam Era Twin Registry members who served during the Vietnam Era.		two years	No
Secondary	Characterize the physical health of Vietnam Era Twin Registry members who served during the Vietnam Era.		two years	No
Secondary	Characterize the level of current disability in Vietnam Era Twin Registry members who served during the Vietnam Era.		two years	No