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临床试验/NCT02085512
NCT02085512已完成不适用

Prevention of PTSD by Neurocognitive Training of Emotional Regulation

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年3月17日最近更新:
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
180
试验地点
2
主要终点
Amelioration of neurocognitive impairments that are associated with post-traumatic stress disorder

研究概览

简要总结

The proposed work will evaluate the ability of neurocognitive retraining of executive functions and emotional regulation to reduce neurocognitive dysfunctions that follow trauma exposure and thereby prevent PTSD. The scientific rationale for this work is the hypothesis that impaired emotional regulation interferes with the expected recovery from the early responses to traumatic events, leading into a chronic disorder. In an initial phase the investigators will recruit 20 recently traumatized participants among trauma survivors admitted to a general hospital emergency room and test the planned intervention's acceptance and right 'dosing'. In the second phase the investigators will enroll 80 recent survivors into a randomized controlled study of the new intervention. The intervention will consist of web-based neurobehavioral training interventions that instill an emotional bias toward positive stimuli, improve emotion recognition and labeling, reduce resistance to emotional distraction, and enhance executive functioning. Control participants will complete web-based video games that do not have emotion-regulatory benefits. Outcome measures will include improvement in neurocognitive functioning and in PTSD symptoms.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult survivors of traumatic events consecutively admitted to a general hospital Emergency Department

排除标准

  • Chronic PTSD at the time of the traumatic event. Current and lifetime psychotic or bipolar illness, current substance abuse save alcohol, medical condition precluding participation.

研究组 & 干预措施

Neurocognitive retraining

Experimental

Neurobehavioral training will be delivered through the web, with prompting for training tasks accomplished through daily emails that include a single integrated log-in system using a customized implementation with OneLogin. All training tasks have "game-like" features making them visually engaging, and motivating. The training tasks provide immediate feedback about performance, and are specifically designed to target circuitry critical for executive functioning (EF) and emotional reactivity.

干预措施: Neurocognitive retraining Web Based Intervention (Procedure)

Control, Web Based Tasks

Placebo Comparator

Engaging daily, for 30 days in web-based video games or reading tasks that do not specifically engage or train neurocognitive functions.

干预措施: Control, web-based tasks (Other)

结局指标

主要结局

Amelioration of neurocognitive impairments that are associated with post-traumatic stress disorder

时间窗: Three and nine months after a traumatic event

Impairments in emotional reactivity, emotion regulation, and executive functioning critically contribute to post-trauma psychopathology (including, but not restricted to PTSD). The primary outcome measure of this work are changes (improvements) of these functions at the immediate aftermath of treatment and six months later

次要结局

  • Post-traumatic Stress Disorder (PTSD) symptoms(Three and nine months after a traumatic event)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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