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临床试验/NCT00838006
NCT00838006已完成不适用

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

Biomedical Research Foundation2 个研究点 分布在 1 个国家目标入组 426 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
426
试验地点
2
主要终点
The PTSD Checklist - Military Version

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Implantable pacemaker or cardiac defibrillator
  • Unable to wear a virtual reality headset

结局指标

主要结局

The PTSD Checklist - Military Version

时间窗: 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.

次要结局

  • Patient Health Questionnaire (PHQ-9)(pre-deployment, 3-, and 12-month post-deployment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey Pyne

Research Scientist

Biomedical Research Foundation

研究点 (2)

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