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Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00838006
First Posted: February 6, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey Pyne, Biomedical Research Foundation
February 4, 2009
February 6, 2009
October 12, 2017
September 2008
September 2013   (Final data collection date for primary outcome measure)
post-traumatic stress symptom severity [ Time Frame: 3- and 12-months post-deployment ]
Same as current
Complete list of historical versions of study NCT00838006 on ClinicalTrials.gov Archive Site
Depression symptom severity [ Time Frame: 3- and 12-month post-deployment ]
Same as current
Not Provided
Not Provided
 
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Post-traumatic Stress Disorder
  • Device: heart rate variability biofeedback
    Heart rate variability biofeedback, 3 session plus handheld device
  • Device: Cognitive bias modification training
    Cognitive bias modification training - 3 session plus handheld device
  • Device: Sham Comparator
    Subjects received iPod without a study app and no additional resilience training
  • Experimental: Biofeedback training
    Heart rate variability biofeedback training and iPod with Breath Pacer app
    Intervention: Device: heart rate variability biofeedback
  • Experimental: Cognitive bias modification training
    Cognitive bias modification training and iPod with cognitive bias training app
    Intervention: Device: Cognitive bias modification training
  • Sham Comparator: Control Group
    No additional resilience training and iPod with no resilience training apps
    Intervention: Device: Sham Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
426
September 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00838006
PT074626
No
Not Provided
Not Provided
Jeffrey Pyne, Biomedical Research Foundation
Biomedical Research Foundation
Not Provided
Principal Investigator: Jeffrey M Pyne, MD Central Arkansas Veterans Healthcare System
Biomedical Research Foundation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP