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Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Pyne, Biomedical Research Foundation
ClinicalTrials.gov Identifier:
NCT00838006
First received: February 4, 2009
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Post-traumatic Stress Disorder
 Device: heart rate variability biofeedback
Device: Cognitive bias modification training
Device: Sham Comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Identification of and At-Risk Interventions for Pre-deployment Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biomedical Research Foundation:

Primary Outcome Measures:
  • post-traumatic stress symptom severity [ Time Frame: 3- and 12-months post-deployment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression symptom severity [ Time Frame: 3- and 12-month post-deployment ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838006

Locations
United States, Virginia
Virginia Army National Guard
Blackstone, Virginia, United States, 23824
Sponsors and Collaborators
Biomedical Research Foundation
Investigators
Principal Investigator: Jeffrey M Pyne, MD Central Arkansas Veterans Healthcare System
  More Information

No publications provided

Responsible Party: Jeffrey Pyne, Research Scientist, Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT00838006     History of Changes
Other Study ID Numbers: PT074626
Study First Received: February 4, 2009
Last Updated: February 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Biomedical Research Foundation:
post-traumatic stress disorder
post-deployment
prediction
prevention

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013