Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838006
• Other study ID #: PT074626
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: September 2013

Study information

• Verified date: June 2020
• Source: Biomedical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• heart rate variability biofeedback
Heart rate variability biofeedback, 3 session plus handheld device
• Cognitive bias modification training
Cognitive bias modification training - 3 session plus handheld device
• Sham Comparator
Subjects received iPod without a study app and no additional resilience training

Locations

Country	Name	City	State
United States	Virginia Army National Guard	Blackstone	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Biomedical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	pre-deployment, 3-, and 12-month post-deployment