Posttraumatic Stress DisorderNCT00451659
Characterization of Recently Deployed Veterans
An observational study of Posttraumatic Stress Disorder, run by Tuscaloosa Research & Education Advancement Corporation at 1 site in United States.
Trial summary
This study is a retrospective chart review of recently deployed veterans who served during the Iraq conflicts and were seen at the TVAMC in the outpatient Primary Care outpatient clinic that was recently set-up for newly returning veterans since its inception through July 1, 2005. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Feb 2007
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, any race or ethic origin, at least 19 years of age
- Patients must have been seen by a provider in the outpatient Primary Care Clinic that has recently been set-up to serve recently deployed veterans who served during the Iraq conflict
Who cannot join
- Patients who did not serve during the Iraq conflict
Trial locations and contacts
1 site in 1 country.
About this study
This study is a retrospective chart review of recently deployed veterans who served during the Iraq conflicts and were seen at the TVAMC in the outpatient Primary Care outpatient clinic that was recently set-up for newly returning veterans since its inception through July 1, 2005. Identical data will be collected on non-combat veterans that were seen in other primary care clinics at the Tuscaloosa VA Medical Center during June 2004 and July 1, 2005. This information will be used for comparison with the Iraqi veterans group. The data will be retrieved from a computerized list of these patients. Charts will then be examined to determine sociodemographic, medical, psychiatric, and health care utilization characteristics.
Read the detailed description
The information will also be used internally at the TVAMC to better define treatment needs and also used in presentations and possible publications at professional meetings and in journals.
While this study is designed to be hypothesis generating for large prospective studies, we hypothesize that a majority of the recently deployed veterans who served in the Iraq conflict are in need of basic primary health care needs for illnesses that are common place among patients within this age group, except for a higher than expected prevalence of mood and anxiety disorders compared to usual primary care treatment-seeking populations.
This study is a retrospective chart review of recently deployed veterans who served during the Iraq conflicts and were seen at the TVAMC in the outpatient Primary Care outpatient clinic that was recently set-up for newly returning veterans since its inception through July 1, 2005. Identical data will be collected on non-combat veterans that were seen in other primary care clinics at the Tuscaloosa VA Medical Center during June 2004 and July 1, 2005. This information will be used for comparison with the Iraqi veterans group. The data will be retrieved from a computerized list of these patients. Charts will then be examined to determine sociodemographic, medical, psychiatric, and health care utilization characteristics.
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Veterans, Deployed
- Medical subject headings
- Stress Disorders, Post-Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startFeb 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Tuscaloosa Research & Education Advancement Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Lori L Davis, MD, Principal investigator, TVAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451659
- Sponsor's protocol ID
- 0053
- Status last verified
- Mar 2007
- First submitted
- 21 Mar 2007
- Last updated
- 23 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolfe J, Proctor SP, Erickson DJ, Heeren T, Friedman MJ, Huang MT, Sutker PB, Vasterling JJ, White RF. Relationship of psychiatric status to Gulf War veterans' health problems. Psychosom Med. 1999 Jul-Aug;61(4):532-40. doi: 10.1097/00006842-199907000-00018.
PubMed 10443762
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Recently Deployed Veterans
- ClinicalTrials.gov ID
- NCT00451659
- Acronym / sponsor ID
- 0053
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Veterans, Deployed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Tuscaloosa Research & Education Advancement CorporationUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 23 Mar 2007 (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.
This study is a retrospective chart review of recently deployed veterans who served during the Iraq conflicts and were seen at the TVAMC in the outpatient Primary Care outpatient clinic that was recently set-up for newly returning veterans since its inception through July 1, 2005. Identical data will be collected on non-combat veterans that were seen in other primary care clinics at the Tuscaloosa VA Medical Center during June 2004 and July 1, 2005. This information will be used for comparison with the Iraqi veterans group. The data will be retrieved from a computerized list of these patients. Charts will then be examined to determine sociodemographic, medical, psychiatric, and health care utilization characteristics.
Detailed description
The information will also be used internally at the TVAMC to better define treatment needs and also used in presentations and possible publications at professional meetings and in journals.
While this study is designed to be hypothesis generating for large prospective studies, we hypothesize that a majority of the recently deployed veterans who served in the Iraq conflict are in need of basic primary health care needs for illnesses that are common place among patients within this age group, except for a higher than expected prevalence of mood and anxiety disorders compared to usual primary care treatment-seeking populations.
This study is a retrospective chart review of recently deployed veterans who served during the Iraq conflicts and were seen at the TVAMC in the outpatient Primary Care outpatient clinic that was recently set-up for newly returning veterans since its inception through July 1, 2005. Identical data will be collected on non-combat veterans that were seen in other primary care clinics at the Tuscaloosa VA Medical Center during June 2004 and July 1, 2005. This information will be used for comparison with the Iraqi veterans group. The data will be retrieved from a computerized list of these patients. Charts will then be examined to determine sociodemographic, medical, psychiatric, and health care utilization characteristics.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients, any race or ethic origin, at least 19 years of age
- Patients must have been seen by a provider in the outpatient Primary Care Clinic that has recently been set-up to serve recently deployed veterans who served during the Iraq conflict
Key exclusion criteria (1 listed)
- Patients who did not serve during the Iraq conflict
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
Not reported in the source record.
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 23 Mar 2007.
- Background: PubMed 10443762Wolfe J, Proctor SP, Erickson DJ, Heeren T, Friedman MJ, Huang MT, Sutker PB, Vasterling JJ, White RF. Relationship of psychiatric status to Gulf War veterans' health problems. Psychosom Med. 1999 Jul-Aug;61(4):532-40. doi: 10.1097/00006842-199907000-00018.
- Department of Veterans Affairs: VA War Related Illness and Injury Study CentersLink provided by the sponsor.
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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.
Lori L Davis, MD principal investigator
TVAMC
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 Posttraumatic Stress Disorder, run by Tuscaloosa Research & Education Advancement Corporation 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 23 Mar 2007. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00451659, which also lists 1 linked publication.
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 23 Mar 2007.