Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

Biomedical Research Foundation426 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

426

Conditions

Post-traumatic Stress Disorder

Interventions

heart rate variability biofeedbackDEVICE

Heart rate variability biofeedback, 3 session plus handheld device

Cognitive bias modification trainingDEVICE

Cognitive bias modification training - 3 session plus handheld device

Sham ComparatorDEVICE

Subjects received iPod without a study app and no additional resilience training

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Virginia Army National Guard

Blackstone, Virginia, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: pre-deployment, 3-, and 12-month post-deployment

Data from ClinicalTrials.gov

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