Skip to main content
OpenTrials
Completed

NCT Number: NCT00838006

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Army National Guard

Blackstone, Virginia, 23824, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

heart rate variability biofeedback

Device

Heart rate variability biofeedback, 3 session plus handheld device

Cognitive bias modification training

Device

Cognitive bias modification training - 3 session plus handheld device

Sham Comparator

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Biomedical Research Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 6, 2009
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.