Post-Traumatic Stress DisorderHealth ViEWSNCT00958061
Long Term Health Outcomes of Women Veterans' Service During the Vietnam Era
An observational study of Post-Traumatic Stress Disorder and Depression, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Little is known about the long-term health and mental health status of women Vietnam veterans. For many of these women, the effects of this war are still present in their daily lives. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder, Depression, Diabetes
- How many people
- 4,219 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2010to 7 Aug 2012
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: For this study we will use a cohort of women who are on a roster of Vietnam Era women veterans (4,644 Vietnam, 1,213 near Vietnam, 5,465 non-Vietnam) previously identified and characterized by a review of their military personnel records and link it to a list of 8,061 women who presumably served in Southeast Asia. This final cohort could potentially contain approximately 14,000 women. After deceased individuals are removed from the active cohort and contact information is updated, we estimate that there could be approximately 10,000 women to whom the informed consent and mailed survey will be initially mailed.
Who may be able to join
- Women alive as of survey receipt who were active duty military personnel in one of the four Armed Services between July 4, 1965, and March 28, 1973, with a 30 day minimum period of service.
- This will include those who served in Vietnam, near Vietnam (Guam, the Philippines, Japan, Korea, Okinawa, or Thailand), or in the 50 United States.
Who cannot join
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, California, 29401-5799
About this study
Official title: CSP #579 - Long Term Health Outcomes of Women's Service During the Vietnam Era
Little is known about the long-term health and mental health status of women Vietnam veterans. For many of these women, the effects of this war are still present in their daily lives. As these women 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 propose to assess the prevalence of posttraumatic stress disorder (PTSD) and other mental and physical health conditions for women Vietnam veterans, and to explore the relationship between PTSD and other conditions and the Vietnam deployment experience. The investigators are interested in studying women Vietnam veterans who may have had direct exposure to traumatic events. For the first time, the investigators also want to study those who served in facilities near Vietnam. These women may have had similar, but less direct exposures. This cross-sectional study will seek to contact approximately 10,000 women for participation in a mailed survey, telephone interview and a review of their medical records. Women identified as serving in Vietnam, near Vietnam (in Asia during the Vietnam Ware) and in the U.S. during the Vietnam War will be identified from an established cohort and sent a survey on demographics, behaviors, disability, health-related quality of life, and medical conditions. Women agreeing to be contacted will also be interviewed by study investigators using the modified CIDI to ascertain current and lifetime mental health conditions (including PTSD) and exposure to traumatic events. A more extensive chart review will be conducted by a clinician to validate self-report of key medical conditions.
- Keywords
- CVD
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Diabetes Mellitus, Cardiovascular Diseases
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 |
|---|---|---|
| Vietnam-Era Women Veterans | For this study we will use a cohort of women who are on a roster of Vietnam Era women veterans (4,644 Vietnam, 1,213 near Vietnam, 5,465 non-Vietnam) previously identified and characterized by a review of their military personnel records and link it to a list of 8,061 women who presumably served in Southeast Asia. This final cohort could potentially contain approximately 14,000 women. After deceased individuals are removed from the active cohort and contact information is updated, we estimate that there could be approximately 10,000 women to whom the informed consent and mailed survey will be initially mailed. |
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 among women who served during the Vietnam Era.
The prevalence of lifetime and current psychiatric conditions including PTSD among women who served during the Vietnam Era.
Measured: two years
Secondary outcomes (2)
Characterize the physical health of women who served during the Vietnam Era.
Characterize the physical health of women who served during the Vietnam Era.
Measured: two years
Characterize the level of current disability in women who served during the Vietnam Era.
Characterize the level of current disability in women 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 posted13 Aug 2009 (estimated)
- Study start1 Mar 2010
- Primary completion7 Aug 2012
- Study completion7 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- 4,219 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kathryn M. Magruder, PhD MPH BA, Study chair, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958061
- Sponsor's protocol ID
- 579
- Acronym
- Health ViEWS
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2009
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kilbourne AM, Schumacher K, Frayne SM, Cypel Y, Barbaresso MM, Nord KM, Perzhinsky J, Lai Z, Prenovost K, Spiro A, Gleason TC, Kimerling R, Huang GD, Serpi TB, Magruder KM. Physical Health Conditions Among a Population-Based Cohort of Vietnam-Era Women Veterans: Agreement Between Self-Report and Medical Records. J Womens Health (Larchmt). 2017 Nov;26(11):1244-1251. doi: 10.1089/jwh.2016.6069. Epub 2017 Aug 7.
PubMed 28783423Schmidt EM, Magruder K, Kilbourne AM, Stock EM, Cypel Y, El Burai Felix S, Serpi T, Kimerling R, Cohen B, Spiro A, Furey J, Huang GD, Frayne SM. Four Decades after War: Incident Diabetes among Women Vietnam-Era Veterans in the HealthViEWS Study. Womens Health Issues. 2019 Nov-Dec;29(6):471-479. doi: 10.1016/j.whi.2019.08.002. Epub 2019 Sep 10.
PubMed 31519465Kimerling R, Serpi T, Weathers F, Kilbourne AM, Kang H, Collins JF, Cypel Y, Frayne SM, Furey J, Huang GD, Reinhard MJ, Spiro A, Magruder K. Diagnostic accuracy of the Composite International Diagnostic Interview (CIDI 3.0) PTSD module among female Vietnam-era veterans. J Trauma Stress. 2014 Apr;27(2):160-7. doi: 10.1002/jts.21905.
PubMed 24740869Kang HK, Cypel Y, Kilbourne AM, Magruder KM, Serpi T, Collins JF, Frayne SM, Furey J, Huang GD, Kimerling R, Reinhard MJ, Schumacher K, Spiro A 3rd. HealthViEWS: mortality study of female US Vietnam era veterans, 1965-2010. Am J Epidemiol. 2014 Mar 15;179(6):721-30. doi: 10.1093/aje/kwt319. Epub 2014 Jan 30.
PubMed 24488510Magruder K, Serpi T, Kimerling R, Kilbourne AM, Collins JF, Cypel Y, Frayne SM, Furey J, Huang GD, Gleason T, Reinhard MJ, Spiro A, Kang H. Prevalence of Posttraumatic Stress Disorder in Vietnam-Era Women Veterans: The Health of Vietnam-Era Women's Study (HealthVIEWS). JAMA Psychiatry. 2015 Nov;72(11):1127-34. doi: 10.1001/jamapsychiatry.2015.1786.
PubMed 26445103Serier KN, Burns HM, Magruder KM, Spiro A, Pless Kaiser A, Kimerling R, Frayne SM, Kilbourne AM, Stock EM, Forsberg CW, Smith NL, Smith BN. Functioning and disability consequences of comorbid posttraumatic stress disorder and diabetes in Vietnam era men and women veterans. Health Psychol. 2025 Dec;44(12):1160-1170. doi: 10.1037/hea0001516. Epub 2025 Jun 12.
PubMed 40504650
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #579 - Long Term Health Outcomes of Women's Service During the Vietnam Era
- ClinicalTrials.gov ID
- NCT00958061
- Acronym / sponsor ID
- Health ViEWS / 579
- Keywords
- CVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,219 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 7 Aug 2012 (actual)
- Study completion
- 7 Aug 2012 (actual)
- First posted
- 13 Aug 2009 (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.
Little is known about the long-term health and mental health status of women Vietnam veterans. For many of these women, the effects of this war are still present in their daily lives. As these women 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 propose to assess the prevalence of posttraumatic stress disorder (PTSD) and other mental and physical health conditions for women Vietnam veterans, and to explore the relationship between PTSD and other conditions and the Vietnam deployment experience. The investigators are interested in studying women Vietnam veterans who may have had direct exposure to traumatic events. For the first time, the investigators also want to study those who served in facilities near Vietnam. These women may have had similar, but less direct exposures. This cross-sectional study will seek to contact approximately 10,000 women for participation in a mailed survey, telephone interview and a review of their medical records. Women identified as serving in Vietnam, near Vietnam (in Asia during the Vietnam Ware) and in the U.S. during the Vietnam War will be identified from an established cohort and sent a survey on demographics, behaviors, disability, health-related quality of life, and medical conditions. Women agreeing to be contacted will also be interviewed by study investigators using the modified CIDI to ascertain current and lifetime mental health conditions (including PTSD) and exposure to traumatic events. A more extensive chart review will be conducted by a clinician to validate self-report of key medical conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vietnam-Era Women Veterans | – | –For this study we will use a cohort of women who are on a roster of Vietnam Era women veterans (4,644 Vietnam, 1,213 near Vietnam, 5,465 non-Vietnam) previously identified and characterized by a review of their military personnel records and link it to a list of 8,061 women who presumably served in Southeast Asia. This final cohort could potentially contain approximately 14,000 women. After deceased individuals are removed from the active cohort and contact information is updated, we estimate that there could be approximately 10,000 women to whom the informed consent and mailed survey will be initially mailed. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For this study we will use a cohort of women who are on a roster of Vietnam Era women veterans (4,644 Vietnam, 1,213 near Vietnam, 5,465 non-Vietnam) previously identified and characterized by a review of their military personnel records and link it to a list of 8,061 women who presumably served in Southeast Asia. This final cohort could potentially contain approximately 14,000 women. After deceased individuals are removed from the active cohort and contact information is updated, we estimate that there could be approximately 10,000 women to whom the informed consent and mailed survey will be initially mailed.
Key inclusion criteria (2 listed)
- Women alive as of survey receipt who were active duty military personnel in one of the four Armed Services between July 4, 1965, and March 28, 1973, with a 30 day minimum period of service.
- This will include those who served in Vietnam, near Vietnam (Guam, the Philippines, Japan, Korea, Okinawa, or Thailand), or in the 50 United States.
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 among women who served during the Vietnam Era.
Time frame: two years
The prevalence of lifetime and current psychiatric conditions including PTSD among women who served during the Vietnam Era.
2 secondary outcomes
Characterize the physical health of women who served during the Vietnam Era.
Time frame: two years
Characterize the level of current disability in women 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 25 Aug 2021.
- Results publication: PubMed 28783423Kilbourne AM, Schumacher K, Frayne SM, Cypel Y, Barbaresso MM, Nord KM, Perzhinsky J, Lai Z, Prenovost K, Spiro A, Gleason TC, Kimerling R, Huang GD, Serpi TB, Magruder KM. Physical Health Conditions Among a Population-Based Cohort of Vietnam-Era Women Veterans: Agreement Between Self-Report and Medical Records. J Womens Health (Larchmt). 2017 Nov;26(11):1244-1251. doi: 10.1089/jwh.2016.6069. Epub 2017 Aug 7.
- Results publication: PubMed 31519465Schmidt EM, Magruder K, Kilbourne AM, Stock EM, Cypel Y, El Burai Felix S, Serpi T, Kimerling R, Cohen B, Spiro A, Furey J, Huang GD, Frayne SM. Four Decades after War: Incident Diabetes among Women Vietnam-Era Veterans in the HealthViEWS Study. Womens Health Issues. 2019 Nov-Dec;29(6):471-479. doi: 10.1016/j.whi.2019.08.002. Epub 2019 Sep 10.
- Results publication: PubMed 24740869Kimerling R, Serpi T, Weathers F, Kilbourne AM, Kang H, Collins JF, Cypel Y, Frayne SM, Furey J, Huang GD, Reinhard MJ, Spiro A, Magruder K. Diagnostic accuracy of the Composite International Diagnostic Interview (CIDI 3.0) PTSD module among female Vietnam-era veterans. J Trauma Stress. 2014 Apr;27(2):160-7. doi: 10.1002/jts.21905.
- Results publication: PubMed 24488510Kang HK, Cypel Y, Kilbourne AM, Magruder KM, Serpi T, Collins JF, Frayne SM, Furey J, Huang GD, Kimerling R, Reinhard MJ, Schumacher K, Spiro A 3rd. HealthViEWS: mortality study of female US Vietnam era veterans, 1965-2010. Am J Epidemiol. 2014 Mar 15;179(6):721-30. doi: 10.1093/aje/kwt319. Epub 2014 Jan 30.
- Results publication: PubMed 26445103Magruder K, Serpi T, Kimerling R, Kilbourne AM, Collins JF, Cypel Y, Frayne SM, Furey J, Huang GD, Gleason T, Reinhard MJ, Spiro A, Kang H. Prevalence of Posttraumatic Stress Disorder in Vietnam-Era Women Veterans: The Health of Vietnam-Era Women's Study (HealthVIEWS). JAMA Psychiatry. 2015 Nov;72(11):1127-34. doi: 10.1001/jamapsychiatry.2015.1786.
- Derived from this study: PubMed 40504650Serier KN, Burns HM, Magruder KM, Spiro A, Pless Kaiser A, Kimerling R, Frayne SM, Kilbourne AM, Stock EM, Forsberg CW, Smith NL, Smith BN. Functioning and disability consequences of comorbid posttraumatic stress disorder and diabetes in Vietnam era men and women veterans. Health Psychol. 2025 Dec;44(12):1160-1170. doi: 10.1037/hea0001516. Epub 2025 Jun 12.
- Individual participant dataSharing planned: No
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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.
Kathryn M. Magruder, PhD MPH BA study chair
Ralph H. Johnson VA Medical Center, Charleston, SC
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 Post-Traumatic Stress Disorder and Depression, run by VA Office of Research and Development 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 2 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 25 Aug 2021. 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 among women 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 NCT00958061, which also lists 6 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 25 Aug 2021.