Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-09-30

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.

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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.

Conditions

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Post-traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Biofeedback training

Heart rate variability biofeedback training and iPod with Breath Pacer app

Group Type EXPERIMENTAL

heart rate variability biofeedback

Intervention Type DEVICE

Heart rate variability biofeedback, 3 session plus handheld device

Cognitive bias modification training

Cognitive bias modification training and iPod with cognitive bias training app

Group Type EXPERIMENTAL

Cognitive bias modification training

Intervention Type DEVICE

Cognitive bias modification training - 3 session plus handheld device

Control Group

No additional resilience training and iPod with no resilience training apps

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type DEVICE

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

Interventions

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heart rate variability biofeedback

Heart rate variability biofeedback, 3 session plus handheld device

Intervention Type DEVICE

Cognitive bias modification training

Cognitive bias modification training - 3 session plus handheld device

Intervention Type DEVICE

Sham Comparator

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

Intervention Type DEVICE

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.