Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans
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| ClinicalTrials.gov Identifier: NCT00657787 |
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Recruitment Status : Unknown
Verified January 2016 by Boston VA Research Institute, Inc..
Recruitment status was: Active, not recruiting
First Posted : April 14, 2008
Last Update Posted : January 21, 2016
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The overall objective of this project is to develop the first longitudinal registry of combat-exposed men and women with PTSD. This registry will provide essential data on the natural history, including progression and remission, and outcomes associated with PTSD in military service men and women who have utilized the Department of Veterans Affairs (VA) health care system. Additional goals of this project are to determine risk factors for PTSD among combat-exposed service men and women (by incorporating a combat-exposed non-PTSD group of veterans into analyses), and to assess the joint effects of combat exposure and PTSD on a broad range of outcome measures (by incorporating a non-combat-exposed group of veterans into analyses). Thus, the registry will allow an evaluation of current theoretical models of symptom development and progression in a large sample of service men and women who utilize the VA medical system.
In addition to the PTSD registry, we will collect information on two comparison groups of OIF/OEF-era veterans to conduct nested case control studies within the general VA health care utilization database. First, a comparison group of combat veterans who are high utilizers of VA medical care, but who have not received a diagnosis of PTSD will be identified. This group will be used in analyses to identify risk factors for PTSD. Additionally, the rate of PTSD symptoms will be evaluated in this comparison group to estimate the prevalence of missed PTSD diagnoses among combat veterans with high rates of service utilization, and the resulting impact on utilization and outcomes. A second comparison group will consist of veterans with similar service record and demographic backgrounds, who were not deployed to the OIF/OEF war zones. Thus, the proposed project will create a PTSD registry from the VA database to assess the natural history and progression of PTSD in combat veterans from OIF/OEF and also to conduct case-control studies nested within the VA database. The case-control comparisons will be used to evaluate key hypotheses related to the specific aims of the overall project.
| Condition or disease |
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| Stress Disorders, Post-Traumatic |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 1600 participants |
| Observational Model: | Case Control |
| Time Perspective: | Prospective |
| Official Title: | Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans |
| Study Start Date : | September 2008 |
| Estimated Study Completion Date : | September 2017 |
| Group/Cohort |
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PTSD
Combat-exposed men and women with PTSD deployed to OIF/OEF.
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High Utilizers
A comparison group of combat veterans who are high utilizers of VA medical care, but who have not received a diagnosis of PTSD
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Not OIF/OEF
A second comparison group will consist of veterans with similar service record and demographic backgrounds, who were not deployed to the OIF/OEF war zones
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- PTSD Diagnosis [ Time Frame: over the course of the study ]
- Life stresses and trauma [ Time Frame: Past and current ]
- Anxiety and Depression [ Time Frame: Past and Current ]
- Alcohol and Substance Use [ Time Frame: past and current ]
- Traumatic Brain Injury [ Time Frame: Past ]
- Social and Occupational Support [ Time Frame: Current ]
- Quality of Life [ Time Frame: Current ]
- Sleep Quality [ Time Frame: Current ]
- Treatment and Service Utilization [ Time Frame: Current ]
- Global Assessment of Functioning [ Time Frame: Current ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Veteran
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657787
| United States, Massachusetts | |
| VA Boston Healthcare System (Jamaica Plain Campus) | |
| Boston, Massachusetts, United States, 02130 | |
| Principal Investigator: | Terence M Keane, PhD | BUSM; VA Boston Healthcare System |
| Responsible Party: | Boston VA Research Institute, Inc. |
| ClinicalTrials.gov Identifier: | NCT00657787 History of Changes |
| Other Study ID Numbers: |
PT075235 |
| First Posted: | April 14, 2008 Key Record Dates |
| Last Update Posted: | January 21, 2016 |
| Last Verified: | January 2016 |
Keywords provided by Boston VA Research Institute, Inc.:
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Posttraumatic Stress Disorder Veterans Health Services |
Additional relevant MeSH terms:
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Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic |
Pathologic Processes Trauma and Stressor Related Disorders Mental Disorders |