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Clinical Trials/NCT00838006
NCT00838006
Completed
Not Applicable

Identification of and At-Risk Interventions for Pre-deployment Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

Biomedical Research Foundation1 site in 1 country426 target enrollmentSeptember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-traumatic Stress Disorder
Sponsor
Biomedical Research Foundation
Enrollment
426
Locations
1
Primary Endpoint
The PTSD Checklist - Military Version
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.

Detailed Description

The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions. The objective predictors will be based on: 1) physiologic reactivity (heart rate, heart rate variability, eye blink startle, skin conductance) to virtual reality (VR) environments depicting common Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF) combat scenarios and 2) cognitive bias assessment using a recognition memory paradigm. We hypothesize that a model combining physiologic reactivity and cognitive bias predictors will be superior to either the physiologic reactivity or cognitive bias model alone for predicting post-deployment PTSD. We also will test two pre-deployment resiliency interventions: heart rate variability biofeedback and cognitive bias modification training that we have designed to target physiologic and cognitive responses to stress, respectively. We will compare the prevention interventions to a no intervention control group. We hypothesize that the prevalence of post-deployment PTSD will be lower in the intervention groups compared to the control group.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
September 2013
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeffrey Pyne

Research Scientist

Biomedical Research Foundation

Eligibility Criteria

Inclusion Criteria

  • Army National Guard members who are scheduled to deploy for OIF/OEF operations within the next 12 months, age 18 to 60, and willing to provide the name and phone number of at least one person to help locate the member for the follow-up assessments if necessary.

Exclusion Criteria

  • Implantable pacemaker or cardiac defibrillator
  • Unable to wear a virtual reality headset

Outcomes

Primary Outcomes

The PTSD Checklist - Military Version

Time Frame: pre-deployment, 3-, and 12-months post-deployment

The Post Traumatic Stress Disorder Checklist is based on Diagnostic Statistical Manual (DSM)-IV symptoms of PTSD. The minimum score is 17 and the maximum score is 85. Higher scores are associated with more severe symptoms and worse outcome.

Secondary Outcomes

  • Patient Health Questionnaire (PHQ-9)(pre-deployment, 3-, and 12-month post-deployment)

Study Sites (1)

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