Virginia Army National Guard
Blackstone, Virginia, 23824, United States
NCT Number: NCT00838006
The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Blackstone, Virginia, 23824, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: pre-deployment, 3-, and 12-months post-deployment
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.
Time frame: pre-deployment, 3-, and 12-month post-deployment
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.
Biomedical Research Foundation
Other
Identification of and At-Risk Interventions for Pre-deployment Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05512143
Cardiovascular Diseases, Hypertension
Providence, Rhode Island, United States
View Trial DetailsNCT03194386
Mental Disorders, Post-traumatic Stress Disorder
Bordeaux, France
View Trial DetailsNCT03519789
Mental Disorders, Post-traumatic Stress Disorder
Lille, France
View Trial DetailsNCT00739765
Anxiety Disorders, Mental Disorders
New York, United States
View Trial Details