Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

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

Detailed Description
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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.

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

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Device: heart rate variability biofeedback
* Device: Cognitive bias modification training
* Device: Sham Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback training<br>Heart rate variability biofeedback training and iPod with Breath Pacer app | Device: heart rate variability biofeedback<br>* Heart rate variability biofeedback, 3 session plus handheld device<br>|
| Experimental: Cognitive bias modification training<br>Cognitive bias modification training and iPod with cognitive bias training app | Device: Cognitive bias modification training<br>* Cognitive bias modification training - 3 session plus handheld device<br>|
| Sham Comparator: Control Group<br>No additional resilience training and iPod with no resilience training apps | Device: Sham Comparator<br>* Subjects received iPod without a study app and no additional resilience training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The PTSD Checklist - Military Version | 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. | pre-deployment, 3-, and 12-months post-deployment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | 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. | pre-deployment, 3-, and 12-month post-deployment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-traumatic stress disorder, post-deployment, prediction, prevention