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Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans

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ClinicalTrials.gov Identifier: NCT00657787
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
Sponsor:
Collaborators:
VA Boston Healthcare System
United States Department of Defense
New England Research Institutes
Boston University
Information provided by (Responsible Party):
Boston VA Research Institute, Inc.

Brief Summary:

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
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

Resource links provided by the National Library of Medicine


Group/Cohort
PTSD
Combat-exposed men and women with PTSD deployed to OIF/OEF.
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
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



Primary Outcome Measures :
  1. PTSD Diagnosis [ Time Frame: over the course of the study ]

Secondary Outcome Measures :
  1. Life stresses and trauma [ Time Frame: Past and current ]
  2. Anxiety and Depression [ Time Frame: Past and Current ]
  3. Alcohol and Substance Use [ Time Frame: past and current ]
  4. Traumatic Brain Injury [ Time Frame: Past ]
  5. Social and Occupational Support [ Time Frame: Current ]
  6. Quality of Life [ Time Frame: Current ]
  7. Sleep Quality [ Time Frame: Current ]
  8. Treatment and Service Utilization [ Time Frame: Current ]
  9. Global Assessment of Functioning [ Time Frame: Current ]


Information from the National Library of Medicine

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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
Study Population
US Military Veterans
Criteria

Inclusion Criteria:

  • Veteran

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
VA Boston Healthcare System (Jamaica Plain Campus)
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Boston VA Research Institute, Inc.
VA Boston Healthcare System
United States Department of Defense
New England Research Institutes
Boston University
Investigators
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.:
Posttraumatic Stress Disorder
Veterans
Health Services

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders