跳至主要内容
临床试验/NCT05874362
NCT05874362招募中不适用

People Bereaved by Violent Death : a Negative Event Biases and Temporal Perception Study

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2023年9月19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
61
试验地点
2
主要终点
Amplitude of the Late Positive Potential (LPP) component in unpredictable event condition

研究概览

简要总结

A violent death is defined by its brutality, unexpectedness and is secondary to an external cause (suicide, homicide, accident). Bereavement following a violent death constitutes a particular clinical situation, at risk of complications. Research on bereavement after a violent death shows higher risks of psychiatric and somatic complications than in bereavement by non-violent death. These complications, sometimes comorbid, take the form of depressive episodes, post-traumatic stress disorders, suicidal behavior and prolonged grief disorders after 12 months, precociously mediated by ruminations.

Processes responsible for this increased risk of complications are poorly documented. Current literature relates mainly to socio-demographic and epidemiological factors which, alone, do not explain this difference in risks. Further research is needed exploring other kinds of data and processes. To our knowledge, there is no description of early neurocognitive functioning in people bereaved after violent death. This study aims at exploring early neurocognitive processes which can lead to complications in people bereaved by violent death.

详细描述

This work is based on cognitive models of post-traumatic stress disorder involving cognitive biases as factors of development and maintenance of symptomatology. Indeed, in people exposed to a potentially traumatic event, it has been found that an early deterioration in cognitive functioning is a risk factor for developing post-traumatic stress disorders . Among these cognitive alterations, attentional biases toward threat are the most explored and research shows both facilitated engagement and difficulties in disengagement in front of threatening stimuli. In addition, while expecting for a negative event, there is changes in the perception of time . These processes can be explored on a behavioral level and in electroencephalography , in particular through the evoked related potentials following a stimulus. Among these evoked related potentials , the Late Positive Potential component reflects the attentional process, while the Contingent Negative Variation component and the α and β power reflects temporal perception.

As exposure to violent death can have a traumatic impact, our hypothesis is that people bereaved by violent death could present attentional biases, and that these biases would be prodromal of the onset of a psychiatric disorder (Post-traumatic stress disorders , depression afterwards). The objective of this study is to describe the presence of these biases through electrophysiological and behavioral measures in a sample of subjects bereaved by violent death.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
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

入选标准

  • An age between 18 and 65 years old
  • Recent bereavement by violent death of a relative in first and second degree

排除标准

  • Protected adults
  • Lack of mastering French language
  • History of neurodegenerative disorder
  • History of psychiatric disorder treated pharmacologically with modification of the basic treatment in the month preceding the death
  • The take of an benzodiazepine treatment in the 24th hours before the first visit (T0)

研究组 & 干预措施

Group with complications at 3 month

Other

Group composed with participants who develop a psychiatric complication (depressive episode or post traumatic stress disorder) 3 month after the death of their loved one.

干预措施: Diagnosis of depressive episode or post traumatic stress disorder (Other)

Group without complication at 3 month

Other

Group composed with participants who do not develop a psychiatric complication (depressive episode or post traumatic stress disorder) 3 month after the death of their loved one.

干预措施: No diagnosis of depressive episode or post traumatic stress disorder (Other)

结局指标

主要结局

Amplitude of the Late Positive Potential (LPP) component in unpredictable event condition

时间窗: Between Day15 and Day30 after the death of one's loved one

Measure in Electroencephalography (EEG) of the Late Positive Potential (LPP), an Event Related Potential (ERP) relating to attention biases

次要结局

  • Comparison of Constant Errors (CE) relative to time estimates in the unpredictability condition (D15-J30) in people developing a psychiatric complication at 3 months and in people not developing these complications.(Between Day15 and Day30 after the death of one's loved one)
  • Amplitude of the Contingent Negative Variation (CNV ) component in unpredictable event condition(Between Day15 and Day30 after the death of one's loved one)
  • Amplitude of the alpha and beta power in unpredictable event condition(Between Day15 and Day30 after the death of one's loved one)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (2)

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