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
1 other identifier
interventional
426
1 country
1
Brief Summary
The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
July 2, 2020
CompletedJuly 2, 2020
June 1, 2020
5 years
February 4, 2009
January 30, 2017
June 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
pre-deployment, 3-, and 12-months post-deployment
Secondary Outcomes (1)
Patient Health Questionnaire (PHQ-9)
pre-deployment, 3-, and 12-month post-deployment
Study Arms (3)
Biofeedback training
EXPERIMENTALHeart rate variability biofeedback training and iPod with Breath Pacer app
Cognitive bias modification training
EXPERIMENTALCognitive bias modification training and iPod with cognitive bias training app
Control Group
SHAM COMPARATORNo additional resilience training and iPod with no resilience training apps
Interventions
Heart rate variability biofeedback, 3 session plus handheld device
Cognitive bias modification training - 3 session plus handheld device
Subjects received iPod without a study app and no additional resilience training
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Implantable pacemaker or cardiac defibrillator
- Unable to wear a virtual reality headset
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Army National Guard
Blackstone, Virginia, 23824, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeff Pyne, MD
- Organization
- Central Arkansas Veterans Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey M Pyne, MD
Central Arkansas Veterans Healthcare System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 6, 2009
Study Start
September 1, 2008
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
July 2, 2020
Results First Posted
July 2, 2020
Record last verified: 2020-06