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临床试验/NCT04651192
NCT04651192已完成不适用

Neurological and Psychological Effects of Combat-Related Stress

Tel Aviv University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change from baseline - PTSD Checklist for DSM-5 (PCL-5) score

研究概览

简要总结

The purpose of this study is to determine what is the neurological and cognitive impact of combat exposure and prolonged stress, in the form of service in the Israeli Defense Forces.

详细描述

Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. This study aimed to characterize the mental resilience of combat soldiers, and explore the neuro-cognitive impact of prolonged stress, using eye-tracking, MRI and fMRI measurements. Participants will be assessed using questionnaires, cognitive tasks and magnetic imaging at 5 timepoints over the span of 4 years. Outcome measures will be depression, anxiety and post-traumatic scores, as well as dwell time on threat in eye-tracking paradigms tested in previous studies, and blood oxygen level-dependent (BOLD) signals in magnetic resonance imaging (MRI) measurements.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 23 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Soldiers in the paratroopers brigade or students in Tel-Aviv University;
  • A signed consent form;
  • Hebrew native speakers.

排除标准

  • A diagnosis of a neurological disorder (i.e., epilepsy, brain injury);
  • Drug or alcohol abuse;
  • Cannot undergo an MRI scan, due to metal implants or other metallic foreign bodies, claustrophobia, large tattoos or irremovable piercings;
  • Require glasses with a number greater than 7;
  • A diagnosis of psychotic or bipolar disorders.

结局指标

主要结局

Change from baseline - PTSD Checklist for DSM-5 (PCL-5) score

时间窗: 4 years, from time point 1 to time point 5

PCL is questionnaire assessing posttraumatic stress disorder symptoms. It contains 20 items on a severity scale of 0-4, measuring the existence and severity of post-traumatic symptoms. The minimal score, indicating no post-traumatic stress, is 0. The maximal score is 80, indicating extremely severe post-traumatic stress.

Neurological measures - Gray matter volume

时间窗: 4 years, from time point 1 to time point 5

Gray matter volume, i.e. the density of brain cells in a particular region (outcome to be measured in cm3), to be derived from the MRI scans, and compared between the two groups across the various time points.

Neurological measures - Functional connectivity

时间窗: 4 years, from time point 1 to time point 5

Functional connectivity, indicating the level of synchronous activity of certain brain regions during rest (temporal correlation is usually expressed as a Pearson's r); Also to be derived from the MRI scans, and compared between the two groups across the various time points.

Neurological measures - Task activations

时间窗: 4 years, from time point 1 to time point 5

Task activations, and specifically the areas activated during the dot-probe task, and how they change over time (expressed as the level of the BOLD signal strength change during the task). To be derived from the MRI scans, and compared between the two groups across the various time points.

Neurological measures - Structural connectivity

时间窗: 4 years, from time point 1 to time point 5

Structural connectivity between regions of the brain (Diffusivity is measured as 10-3mm2.s-1) and the properties of the white matter (expressed with Diffusion tensor imaging (DTI) measures, mainly Fractional Anisotropy (FA) and Mean Diffusivity (MD)); Also be derived from the MRI scans, and compared between the two groups across the various time points.

次要结局

未报告次要终点

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 (1)

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