Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

June 17, 2020 updated by: Jeffrey Pyne, Biomedical Research Foundation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

426

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Blackstone, Virginia, United States, 23824
        • Virginia Army National Guard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-deployment, 3-, and 12-months post-deployment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomedical Research Foundation

Investigators

  • Principal Investigator: Jeffrey M Pyne, MD, Central Arkansas Veterans Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

February 4, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT074626

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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