N/A
N=342
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
Post-traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00838006 ↗Enrolled (actual)
342
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: The PTSD Checklist - Military Version — 22.2; 23.7; 23.8; 25.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- heart rate variability biofeedback (Device); Cognitive bias modification training (Device); Sham Comparator (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biomedical Research Foundation
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The PTSD Checklist - Military Version |
22.2; 23.7; 23.8; 25.9; 26.5; 28.5 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
2.83; 3.02; 3.03 | — |
Summary
The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00838006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.