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

NCT00657787 | Unknown

• 1 other identifier: PT075235
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Posttraumatic Stress Disorder; Veterans; Health Services

Outcome Measures

Primary Outcomes (1)

• PTSD Diagnosis

  PTSD diagnosis based on SCID-5 semi-structured interview

  over the course of the study

Secondary Outcomes (9)

• Life Events Checklist

  Past and current

• Prime-MD Patient Health Questionnaire

  Past and Current

• Alcohol Use Disorder Identification Test (AUDIT)

  past and current

• Defense and Veterans Brain Injury Center TBI questionnaire, modified for brief administration

  Past

• Deployment Risk and Resilience Inventory (DRRI) Section L (Post-deployment support)

  Current

Study Arms (3)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

US Military Veterans

You may qualify if:

• Veteran

Sponsors & Collaborators

• Boston VA Research Institute, Inc.: lead
• VA Boston Healthcare System: collaborator
• United States Department of Defense: collaborator
• Carelon Research: collaborator
• Boston University: collaborator

Study Sites (1)

VA Boston Healthcare System (Jamaica Plain Campus)

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Terence M Keane, PhD

  BUSM; VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2017
• Study Completion: September 1, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

US (1)