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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Boston VA Research Institute, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
VA Boston Healthcare System
New England Research Institutes
Boston University
Information provided by (Responsible Party):
Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00657787
First received: April 8, 2008
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

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
Stress Disorders, Post-Traumatic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans

Resource links provided by NLM:


Further study details as provided by Boston VA Research Institute, Inc.:

Primary Outcome Measures:
  • PTSD Diagnosis [ Time Frame: over the course of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Life stresses and trauma [ Time Frame: Past and current ] [ Designated as safety issue: No ]
  • Anxiety and Depression [ Time Frame: Past and Current ] [ Designated as safety issue: No ]
  • Alcohol and Substance Use [ Time Frame: past and current ] [ Designated as safety issue: No ]
  • Traumatic Brain Injury [ Time Frame: Past ] [ Designated as safety issue: No ]
  • Social and Occupational Support [ Time Frame: Current ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Current ] [ Designated as safety issue: No ]
  • Sleep Quality [ Time Frame: Current ] [ Designated as safety issue: No ]
  • Treatment and Service Utilization [ Time Frame: Current ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning [ Time Frame: Current ] [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: September 2008
Estimated Study Completion Date: August 2012
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

US Military Veterans

Criteria

Inclusion Criteria:

  • Veteran
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
New England Research Institutes
Boston University
Investigators
Principal Investigator: Terence M Keane, PhD BUSM; VA Boston Healthcare System
  More Information

No publications provided

Responsible Party: Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00657787     History of Changes
Other Study ID Numbers: PT075235
Study First Received: April 8, 2008
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston VA Research Institute, Inc.:
Posttraumatic Stress Disorder
Veterans
Health Services

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014