Stress Disorders, Post-TraumaticNCT01175629
Veteran Health Study
An observational study of Stress Disorders, Post-Traumatic and Depression, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depression, Diabetes
- How many people
- 7,568 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All subjects are members of the Vietnam Era Twin Registry, and are males born between 1939-1957.
Who may be able to join
- All twins who are currently active in the VET Registry will be invited to participate in CSP #569.
Who cannot join
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98101
About this study
Official title: CSP #569 - A Twin Study of the Course and Consequences of PTSD in Vietnam Era Veterans
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.
Read more
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.
- Keywords
- Stress Disorders, Post-Traumatic, Depression, Diabetes, Cardiovascular Disease, Depressive Disorder, Behavioral Symptoms, Metabolic Diseases, Mental Disorders, Anxiety Disorders
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Diabetes Mellitus, Cardiovascular Diseases, Depressive Disorder, Behavioral Symptoms, Metabolic Diseases, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The Vietnam Era Twin (VET) Registry is a closed cohort composed of 7,369 middle-aged male-male twin pairs both of whom served in the military during the time of the Vietnam conflict (1965-1975). The Registry is a United States Department of Veterans Affairs resource that was originally constructed from military records; the Registry has been in existence for more than 15 years. It is one of the largest national twin registries in the US and currently has subjects living in all 50 states. Initially formed to address questions about the long-term health effects of service in Vietnam the Registry has evolved into a resource for genetic epidemiological studies of mental and physical health conditions. Several waves of mail and telephone surveys have collected a wealth of health-related information on Registry twins. Other data collection efforts have focused on specific sets of twin pairs and conducted detailed clinical or laboratory testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the prevalence of lifetime and current psychiatric conditions including PTSD in Vietnam Era Twin Registry members who served during the Vietnam Era.
Measured: two years
Secondary outcomes (2)
Characterize the physical health of Vietnam Era Twin Registry members who served during the Vietnam Era.
Measured: two years
Characterize the level of current disability in Vietnam Era Twin Registry members who served during the Vietnam Era.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 7,568 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jack H Goldberg, PhD MA BA, Study chair, VA Puget Sound Health Care System, SeattleKathryn M. Magruder, PhD MPH BA, Study chair, Ralph H Johnson VA Medical Center, Charleston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175629
- Sponsor's protocol ID
- 569
- Status last verified
- Jun 2014
- First submitted
- 3 Aug 2010
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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: 10.1017/S2045796014000365. Epub 2014 Jun 6.
PubMed 24905737Vaccarino 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: 10.1016/j.jpsychires.2014.05.019. Epub 2014 Jun 9.
PubMed 24950602Goldberg J, Magruder KM, Forsberg CW, Kazis LE, Ustun 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 course and consequences of posttraumatic stress disorder in Vietnam-era veteran twins). Qual Life Res. 2014 Jun;23(5):1579-91. doi: 10.1007/s11136-013-0585-4. Epub 2013 Dec 7.
PubMed 24318083
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #569 - A Twin Study of the Course and Consequences of PTSD in Vietnam Era Veterans
- ClinicalTrials.gov ID
- NCT01175629
- Acronym / sponsor ID
- 569
- Keywords
- Stress Disorders, Post-Traumatic, Depression, Diabetes, Cardiovascular Disease, Depressive Disorder, Behavioral Symptoms, Metabolic Diseases, Mental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,568 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –The Vietnam Era Twin (VET) Registry is a closed cohort composed of 7,369 middle-aged male-male twin pairs both of whom served in the military during the time of the Vietnam conflict (1965-1975). The Registry is a United States Department of Veterans Affairs resource that was originally constructed from military records; the Registry has been in existence for more than 15 years. It is one of the largest national twin registries in the US and currently has subjects living in all 50 states. Initially formed to address questions about the long-term health effects of service in Vietnam the Registry has evolved into a resource for genetic epidemiological studies of mental and physical health conditions. Several waves of mail and telephone surveys have collected a wealth of health-related information on Registry twins. Other data collection efforts have focused on specific sets of twin pairs and conducted detailed clinical or laboratory testing. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects are members of the Vietnam Era Twin Registry, and are males born between 1939-1957.
Key inclusion criteria (1 listed)
- All twins who are currently active in the VET Registry will be invited to participate in CSP #569.
Key exclusion criteria (1 listed)
- Unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the prevalence of lifetime and current psychiatric conditions including PTSD in Vietnam Era Twin Registry members who served during the Vietnam Era.
Time frame: two years
2 secondary outcomes
Characterize the physical health of Vietnam Era Twin Registry members who served during the Vietnam Era.
Time frame: two years
Characterize the level of current disability in Vietnam Era Twin Registry members who served during the Vietnam Era.
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
- Results publication: PubMed 24905737Magruder 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: 10.1017/S2045796014000365. Epub 2014 Jun 6.
- Results publication: PubMed 24950602Vaccarino 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: 10.1016/j.jpsychires.2014.05.019. Epub 2014 Jun 9.
- Results publication: PubMed 24318083Goldberg J, Magruder KM, Forsberg CW, Kazis LE, Ustun 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 course and consequences of posttraumatic stress disorder in Vietnam-era veteran twins). Qual Life Res. 2014 Jun;23(5):1579-91. doi: 10.1007/s11136-013-0585-4. Epub 2013 Dec 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack H Goldberg, PhD MA BA study chair
VA Puget Sound Health Care System, Seattle
Kathryn M. Magruder, PhD MPH BA study chair
Ralph H Johnson VA Medical Center, Charleston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic and Depression, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prevalence of lifetime and current psychiatric conditions including PTSD in Vietnam Era Twin Registry members who served during the Vietnam Era. (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01175629, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.