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Suicide Risk 30 Days After a Potentially Traumatic Event in Patients Treated by a Medico-psychological Emergency Unit (SCAR)

2022年5月23日 更新者:University Hospital, Grenoble

Suicide Risk Within 30 Days After a Potentially Traumatic Event (PTE) in Patients Treated by a Medico-psychological Emergency Unit. Prospective Cohort Study

The national french survey "Mental health in general population", showed that the risk of suicide was significantly increased during exposure to a potentially traumatic event (PTE), with an increasing gradient depending on the psychological impact. This included not only people suffering from post-traumatic stress disorder but also those confronted with PTE, presenting or having presented phenomena of reviviscence or at least an element of psychopathological impact. This risk could concern 30.2% of the population over the entire lifetime. Internationally, recent reviews of the literature tend to show that victims of interpersonal violence are more at risk of suicide (OR 1.99 95% CI: 1.73-2.28). Nevertheless, the literature remains heterogeneous, the definitions vague and the temporal proximity of the violence little taken into account. It is therefore a large-scale phenomenon that remains little explored.

To increase our knowledge in this area, the investigators will focus on patients treated by Emergency Medical Psychological Cells (CUMP), that is victims of disasters, accidents involving a large number of victims or events that may have significant psychological repercussions due to the circumstances surrounding them.

研究概览

地位

尚未招聘

条件

详细说明

The national french survey "Mental health in general population", showed that the risk of suicide was significantly increased during exposure to a potentially traumatic event (PTE), with an increasing gradient depending on the psychological impact. This included not only people suffering from post-traumatic stress disorder but also those confronted with PTE, presenting or having presented phenomena of reviviscence or at least an element of psychopathological impact. This risk could concern 30.2% of the population over the entire lifetime. Internationally, recent reviews of the literature tend to show that victims of interpersonal violence are more at risk of suicide (OR 1.99 95% CI: 1.73-2.28). Nevertheless, the literature remains heterogeneous, the definitions vague and the temporal proximity of the violence little taken into account. It is therefore a large-scale phenomenon that remains little explored.

To increase our knowledge in this area, the investigators will focus on patients treated by Emergency Medical Psychological Cells (CUMP), that is victims of disasters, accidents involving a large number of victims or events that may have significant psychological repercussions due to the circumstances surrounding them.

Estimate the prevalence of suicide risk 30 days after exposure to a potentially traumatic event, in people treated by a CUMP

The secondary objective aim to identify:

  1. The main psychiatric disorders at 30 days (depressive disorders, bipolar disorders, panic disorder, agoraphobia, social phobia, generalized anxiety, post-traumatic stress disorder, obsessive-compulsive disorder, disorder linked to the consumption of alcohol or other substances, psychotic disorders, eating disorders)
  2. The number of death by suicide 1 year after the trauma
  3. The incidence of suicide attempts 1 year after the trauma
  4. The incidence of suicidal ideation 1 year of trauma Prognostic factors of mortality by suicide, suicide attempts or suicidal ideation will be sought.

A number of 215 individuals would give a precision of ± 5% to a point estimate equal to 15% of the prevalence of suicide risk at 30 days. Assuming a 10% refusal rate to participate in the follow-up visit, this number should be increased to 240 patients.

This number of 215 patients would give 80% power to a logistic regression model of the binary primary endpoint (Y, risk of suicide at 30 days) on a binary independent variable (X) in the presence of a binary covariate (Z). to detect, with an alpha risk of 0.05, an odds ratio equal to 2.50. This number is calculated under the assumption of a baseline risk for the primary endpoint Y of 0.15, the independence of observations, a prevalence of the independent variable X of 50%, a prevalence the covariate Z of 50% and an odds ratio of the primary endpoint Y associated with the covariate Z of 1.50. This number is calculated for a two-tailed Wald test.

The investigators believe that their study could have a real impact on CUMP practices and suicide risk prevention. In fact, the CUMP represents an original device and the context of the emergency and support groups may overlook the risk of suicide for some patients. In addition, there is currently no systematic monitoring planned within the CUMPs. It is therefore an innovative and particularly topical subject that could change clinical practices but also the organization of the healthcare offer. Indeed, several treatment centers for psychotrauma are currently being deployed at the national level (including a center in Lyon, within the Hospices Civils de Lyon (HCL)) and an important work of coordination of treatment structures is in progress.

研究类型

观察性的

注册 (预期的)

240

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Chambéry、法国
        • DELACHENAL Catherine
        • 接触:
          • Catherine DELACHENAL, MD
      • Clermont-Ferrand、法国
        • Geneste-Saelens
        • 接触:
          • Julie GENESTE-SAELENS, MD
      • Lyon、法国
        • VIGNAUD Philippe
        • 接触:
          • Philippe VIGNAUD, MD
      • Montéléger、法国
        • COURVOISIER Pierre
        • 接触:
          • Pierre COURVOISIER, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients fulfilling the inclusion and non-inclusion criteria and having signed the consent will be included. Within 30 days (± 5 days), an appointment, by videoconference, will be made by the CUMP of the Grenoble center for the completion of the MINI scale and screening for suicidal behavior. This interview will be carried out either with the psychiatrist or the psychologist or with the psychiatric resident. If the patient does not answer, the trusted third party or the attending physician will be contacted by telephone in order to investigate the causes or to detect a possible death by suicide. The patient will be followed up one year after inclusion by telephone to detect the number of suicide attempts and/or death.

描述

Inclusion Criteria:

  • Patient treated for the first time by a CUMP directly confronted with a potentially traumatic event (PTE) (with ou without a previous psychiatric history)
  • Patient affiliated with social welfare

Exclusion Criteria:

  • Age under 18
  • Not understanding French language.
  • Not having provided the contact details of a trusted third party and of the attending physician
  • Being homeless
  • Information on the exhibition unavailable (subjects recently arrived in France, foreign language, etc.)
  • A pathology requiring urgent medical treatment
  • Covered by articles L1121-5 to L1121-8 of the CSP (pregnant women, parturients, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care and adults subject to a measure of legal protection or unable to express their consent).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Suicidal risk
大体时间:30 days
Absence or presence of the suicidal risk assessed using the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days

次要结果测量

结果测量
措施说明
大体时间
Depressive disorders
大体时间:30 days
Absence or presence of depressive disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Bipolar disorders
大体时间:30 days
Absence or presence of bipolar disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Panic disorder
大体时间:30 days
Absence or presence of panic disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Agoraphobia
大体时间:30 days
Absence or presence of agoraphobia used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Social phobia
大体时间:30 days
Absence or presence of social phobia used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Generalized anxiety
大体时间:30 days
Absence or presence of generalized anxiety used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Post-traumatic stress disorder
大体时间:30 days
Absence or presence of post-traumatic stress disorder used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Obsessive-compulsive disorder
大体时间:30 days
Absence or presence of obsessive-compulsive disorder used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Disorder linked to the consumption of alcohol or other substances
大体时间:30 days
Absence or presence of disorder linked to the consumption of alcohol or other substances used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Psychotic disorders
大体时间:30 days
Absence or presence of psychotic disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Eating disorders
大体时间:30 days
Absence or presence of eating disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
30 days
Mortality by suicide
大体时间:365 days
Mortality by suicide after the psychological trauma (the cause of death is obtained from a trusted third party or from the attending physician)
365 days
Incidence of suicide
大体时间:365 days
Number of patients having presented at least one suicide attempt during the 365 days after the psychological trauma (declaration of the patient or, in his absence, of the declared trusted person or the general practitioner)
365 days
Incidence of suicidal ideation
大体时间:365 days
Number of patients declaring that they have presented suicidal ideation at least once during the 365 days after the psychological trauma (question yes / no)
365 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Helene Poncet, MD、CHU Grenoble Alpes, SAMU38 - CUMP

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年9月1日

初级完成 (预期的)

2023年8月30日

研究完成 (预期的)

2024年4月30日

研究注册日期

首次提交

2021年5月18日

首先提交符合 QC 标准的

2021年5月18日

首次发布 (实际的)

2021年5月24日

研究记录更新

最后更新发布 (实际的)

2022年5月27日

上次提交的符合 QC 标准的更新

2022年5月23日

最后验证

2022年5月1日

更多信息

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