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Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

Not Applicable
Completed
Conditions
Post-traumatic Stress Disorder
Interventions
Device: Sham Comparator
Device: Cognitive bias modification training
Device: heart rate variability biofeedback
Registration Number
NCT00838006
Lead Sponsor
Biomedical Research Foundation
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
426
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control GroupSham ComparatorNo additional resilience training and iPod with no resilience training apps
Cognitive bias modification trainingCognitive bias modification trainingCognitive bias modification training and iPod with cognitive bias training app
Biofeedback trainingheart rate variability biofeedbackHeart rate variability biofeedback training and iPod with Breath Pacer app
Primary Outcome Measures
NameTimeMethod
The PTSD Checklist - Military Versionpre-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 Outcome Measures
NameTimeMethod
Patient Health Questionnaire (PHQ-9)pre-deployment, 3-, and 12-month post-deployment

The PHQ-9 is a nine-item depression module that is based on DSM-IV criteria for major depression. The minimum score is 0 and the maximum score is 27. Higher scores indicate more severe depression or worse outcome.

Trial Locations

Locations (1)

Virginia Army National Guard

🇺🇸

Blackstone, Virginia, United States

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