Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

Biomedical Research Foundation

Status: Completed

Conditions: Post-traumatic Stress Disorder

Treatments: Device: Sham Comparator; Device: Cognitive bias modification training; Device: heart rate variability biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT00838006

PT074626

Details and patient eligibility

About

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

Full 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.

Enrollment: 426 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

426 participants in 3 patient groups

Biofeedback training

Experimental group

Description:

Heart rate variability biofeedback training and iPod with Breath Pacer app

Treatment:

Device: heart rate variability biofeedback

Cognitive bias modification training

Experimental group

Description:

Cognitive bias modification training and iPod with cognitive bias training app

Treatment:

Device: Cognitive bias modification training

Control Group

Sham Comparator group

Description:

No additional resilience training and iPod with no resilience training apps

Treatment:

Device: Sham Comparator