跳至主要内容
临床试验/NCT06007612
NCT06007612招募中不适用

Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder

Gal Sheppes1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
96
试验地点
1
主要终点
Difference in accurate intensity classification measured during Block A of the experiment

研究概览

简要总结

This study will examine context sensitivity, composed of two sequential elements: (a) accurate classification of changing affective contextual demands, followed by (b) flexible selection of regulatory strategies that matches changing contextual demands, among complex PTSD vs. Healthy controls.

详细描述

The study will recruit adults with posttraumatic stress disorder (PTSD) due to a repetitive inter-personal trauma and healthy adult controls which do not meet DSM-5 criteria for PTSD and do not meet the clinical cutoff of Anxiety and Depression screening questionnaires.

A compatibility check, filtering, verification of exclusion criteria and informed consent will occur via online self-report questionnaires.

Clinical questioners include:

Life event Checklist (LEC) - PTSD criteria A Post-trauma Checklist for DSM-5 (PCL) - PTSD symptoms Patient Health Questionnaire (PHQ-9) - Depression Symptoms General Anxiety Disorder Questioner (GAD-7) - Anxiety Symptoms

Participants who pass the initial filtering, will be called and provided with an explanation about the study following which they received the online experiment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Native Hebrew speakers
  • •age between 18 - 65
  • •normal or corrected to normal vision
  • •computer and internet access
  • •Group 1: Diagnosis of PTSD according to the DSM-5
  • •Group 2: GAD and PHQ scores (score<10), no diagnosis of PTSD according to the DSM-5

排除标准

  • •Psychosis
  • •substance dependence or abuse other than nicotine
  • •Neurological condition

研究组 & 干预措施

Behavioral: Context Sensitivity in Emotion Regulation

Experimental

干预措施: Context Sensitivity in Emotion Regulation (Behavioral)

结局指标

主要结局

Difference in accurate intensity classification measured during Block A of the experiment

时间窗: During the experimental task (1 hour)

comparing the accuracy in intensity classification of 80 words stimuli between the PTSD group and the control group.

regulatory selection flexibility (distraction choice in high intensity minus distraction choice in low intensity) as assessed by regulatory selection paradigm

时间窗: During the experimental task (1 hour)

group comparison of the association between accuracy in intensity classification (as measured in Block A) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block B.

regulatory selection flexibility (measured by distraction choice in high intensity minus distraction choice in low intensity) following provided intensity as assessed by regulatory selection paradigm

时间窗: During the experimental task (1 hour)

group comparison of the association between provided intensity classification (i.e., whether stimuli is of high or low intensity) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block C

次要结局

未报告次要终点

研究者

发起方
Gal Sheppes
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gal Sheppes

Principal Investigator of Emotion Regulation Lab

Tel Aviv University

研究点 (1)

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