Prevention of Posttraumatic Symptoms in IDF Soldiers Using Attention Bias Modification (ABM): A Randomized Controlled Trial
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
- 是
入选标准
- •combat soldiers
排除标准
- •Fluent Hebrew
研究组 & 干预措施
Active ABMT4
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
Control: will not receive any intervention
Active ABMT8
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: 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
Yair Bar-Haim
Professor
Tel Aviv University
