跳至主要内容
临床试验/NCT01723215
NCT01723215已完成不适用

Prevention of Posttraumatic Symptoms in IDF Soldiers Using Attention Bias Modification (ABM): A Randomized Controlled Trial

Tel Aviv University2 个研究点 分布在 1 个国家目标入组 862 人开始时间: 2012年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
862
试验地点
2
主要终点
Probable PTSD diagnosis(CAPS)

研究概览

简要总结

Military deployment to combat zones involves exposure to trauma at a higher than average rate and therefore presents a unique opportunity to study predisposing factors to posttraumatic stress reactions and test strategies designed to prevent and ameliorate posttraumatic symptoms. Decades of scientific research on the origins of resilience and vulnerability to combat-related posttraumatic stress symptoms revealed various predisposing and protective factors. All these factors however, offer limited opportunity for systematic pre-deployment prevention efforts. Considering the magnitude of psychological adjustment difficulties encountered by combat personnel in deployment and the limited access to existing evidence-based therapies for PTSD, the development and testing of a novel evidence-based and theory-driven prevention protocol for these problems is of considerable significance. The current study translates cognitive-neuroscience knowledge and attention bias modification research into a novel computerized training tool that could be easily delivered to soldiers during different stages of the deployment cycle. If proved efficacious in reducing risk for posttraumatic symptoms ABMT could be integrated into the Army's resilience training program. Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers. We will assess attention bias and symptoms before deployment, will randomly assign soldiers to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training. Following 6 months of deployment to combat zone symptoms will be assessed again.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 28 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • combat soldiers

排除标准

  • Fluent Hebrew

研究组 & 干预措施

Active ABMT4

Active Comparator

Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance

干预措施: Active ABMT4 (Behavioral)

Control

No Intervention

Control: will not receive any intervention

Active ABMT8

Active Comparator

Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance

干预措施: Active ABMT8 (Behavioral)

Placebo

Placebo Comparator

Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns

干预措施: Placebo (Behavioral)

结局指标

主要结局

Probable PTSD diagnosis(CAPS)

时间窗: Four months after combat

Four months after combat

Changes in PTSD symptoms(PCL)

时间窗: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat

1\. pre-treatment 2.after first deployment 3.10 days after combat 4. 4 months after combat

次要结局

  • Changes in Depression(PHQ-9)) and Anxiety(STAI)(Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat)

研究者

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

Yair Bar-Haim

Professor

Tel Aviv University

研究点 (2)

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