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Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

Primary Purpose

Post-traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
heart rate variability biofeedback
Cognitive bias modification training
Sham Comparator
Sponsored by
Biomedical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-traumatic Stress Disorder focused on measuring post-traumatic stress disorder, post-deployment, prediction, prevention

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Virginia Army National Guard

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Biofeedback training

Cognitive bias modification training

Control Group

Arm Description

Heart rate variability biofeedback training and iPod with Breath Pacer app

Cognitive bias modification training and iPod with cognitive bias training app

No additional resilience training and iPod with no resilience training apps

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 4, 2009
Last Updated
June 17, 2020
Sponsor
Biomedical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00838006
Brief Title
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
Official Title
Identification of and At-Risk Interventions for Pre-deployment Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biomedical Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
post-traumatic stress disorder, post-deployment, prediction, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
426 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback training
Arm Type
Experimental
Arm Description
Heart rate variability biofeedback training and iPod with Breath Pacer app
Arm Title
Cognitive bias modification training
Arm Type
Experimental
Arm Description
Cognitive bias modification training and iPod with cognitive bias training app
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
No additional resilience training and iPod with no resilience training apps
Intervention Type
Device
Intervention Name(s)
heart rate variability biofeedback
Intervention Description
Heart rate variability biofeedback, 3 session plus handheld device
Intervention Type
Device
Intervention Name(s)
Cognitive bias modification training
Intervention Description
Cognitive bias modification training - 3 session plus handheld device
Intervention Type
Device
Intervention Name(s)
Sham Comparator
Intervention Description
Subjects received iPod without a study app and no additional resilience training
Primary Outcome Measure Information:
Title
The PTSD Checklist - Military Version
Description
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 Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Pyne, MD
Organizational Affiliation
Central Arkansas Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Army National Guard
City
Blackstone
State/Province
Virginia
ZIP/Postal Code
23824
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

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