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Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population (PsyConfPop)

2020年12月28日 更新者：University Hospital, Montpellier

Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population : PsyConfPop

Quarantine is an unpleasant experience : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. It may lead to negative mental health consequences and thus the emergence of anxiety and depressive symptoms.

From March 17th, 2020 to May 11th 2002, the French government has implemented national containment measures due to the Covid-19 epidemic.

Although there are data on the psychological impact and experience of quarantine measures in people who have been infected or suspected of being carriers of certain pathogens (e.g. Ebola), there are no data on such impact in the French population and quarantines lasting longer than 21 days. Investigators therefore propose to conduct a human and social sciences study in order to better understand the current situation

研究概览

地位

未知

条件

干预/治疗

详细说明

The main objective is to describe the psychological state during confinement (and the impact of the confinement) in a sample of the French general population.

Secondary objectives :

  • to assess the evolution of psychological health between the period of confinement and post-confinement.
  • to identify clinical factors modulating psychological state during confinement

It is expected to highlight :

  • a link between the intensity of anxiety symptoms and the number/quality of social contacts
  • a reduction of anxiety and depression symptoms in the post-confinement period.
  • higher consumption of drugs during the confinement period

Self-questionnaires (Google form format) are sent by mailing lists or social networks to participants in order to complete the assessment of psychological state. A unique identifier is sent in a separate email. These assessments are performed at least once during the confinement period. It is planned to repeat them when the confinement is lifted: 15 days, 3 and 6 months after the lifting of the confinement because of the risk of developing anxiodepressive symptoms, in particular post-traumatic stressors.

研究类型

观察性的

注册 (预期的)

500

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。

学习地点

  • 法国
      • Montpellier、法国、34295
        • 招聘中
        • University Hospital
        • 接触：

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

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adults who agree to participate by answering the questionnaires

描述

Inclusion criteria:

- age> 18

Exclusion criteria:

- protective measure (curatorship, guardianship)

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

队列和干预

团体/队列
干预/治疗
Confined patients
General population
其他：Slef questionnaires fulfilment
Questionnaires to assess the psychological impact of confinement and its evolution over 6 months

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
Depressive Symptomatology
大体时间：during confinement
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
during confinement

次要结果测量

结果测量
措施说明
大体时间
Depressive Symptomatology
大体时间：post-confinement : 15 days, 3 months, 6 months
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
post-confinement : 15 days, 3 months, 6 months

其他结果措施

结果测量
措施说明
大体时间
Psychological pain
大体时间：during confinement
Psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
during confinement
sleep
大体时间：during confinement
quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)
during confinement
sleep
大体时间：post-confinement (15 days, 3 months, 6 months)
quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)
post-confinement (15 days, 3 months, 6 months)
anxiety
大体时间：during confinement
anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -> min : 0 max : 21)
during confinement
anxiety
大体时间：post-confinement (15 days, 3 months, 6 months)
anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -> min : 0 max : 21)
post-confinement (15 days, 3 months, 6 months)
psychological pain
大体时间：post-confinement (15 days, 3 months, 6 months)
psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
post-confinement (15 days, 3 months, 6 months)
physical pain
大体时间：during confinement
psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)
during confinement
physical pain
大体时间：post-confinement (15 days, 3 months, 6 months)
psychological pain : likert scale higher score, more psychological pain-> min : 0 max : 10)
post-confinement (15 days, 3 months, 6 months)
anger
大体时间：during confinement
staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)
during confinement
anger
大体时间：post-confinement (15 days, 3 months, 6 months)
staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)
post-confinement (15 days, 3 months, 6 months)
Stressful Event Impact
大体时间：during confinement

Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -> min : 0 max : 45)

)
during confinement
Stressful Event Impact
大体时间：post-confinement (15 days, 3 months, 6 months)
Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -> min : 0 max : 45)
post-confinement (15 days, 3 months, 6 months)
Use of psychotropic drugs
大体时间：during confinement
Number of patients declaring an increase of psychotropic drug use
during confinement
Use of psychotropic drugs
大体时间：post-confinement (15 days, 3 months, 6 months)
Number of patients declaring an increase of psychotropic drug use
post-confinement (15 days, 3 months, 6 months)
Tobacco consumption
大体时间：during confinement
Number of patients declaring an increase of tobacco consumption
during confinement
Tobacco consumption
大体时间：post-confinement (15 days, 3 months, 6 months)
Number of patients declaring an increase of tobacco consumption
post-confinement (15 days, 3 months, 6 months)
alcohol consumption
大体时间：post-confinement (15 days, 3 months, 6 months)
Number of patients declaring an increase of alcohol consumption
post-confinement (15 days, 3 months, 6 months)
alcohol consumption
大体时间：confinement
Number of patients declaring an increase of alcohol consumption
confinement
Illicit substances consumption
大体时间：confinement
Number of patients declaring an increase of illicit substances consumption
confinement
Illicit substances consumption
大体时间：post-confinement (15 days, 3 months, 6 months)
Number of patients declaring an increase of illicit substances consumption
post-confinement (15 days, 3 months, 6 months)
orientation of life
大体时间：confinement
Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24
confinement
orientation of life
大体时间：post-confinement (15 days, 3 months, 6 months)
Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24
post-confinement (15 days, 3 months, 6 months)

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。

赞助

University Hospital, Montpellier

调查人员

  • 首席研究员：Emilie OLIE, MD PhD、University Hospital, Montpellier

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 (实际的)

2020年4月1日

初级完成 (预期的)

2021年12月1日

研究完成 (预期的)

2021年12月30日

研究注册日期

首次提交

2020年4月30日

首先提交符合 QC 标准的

2020年4月30日

首次发布 (实际的)

2020年5月5日

研究记录更新

最后更新发布 (实际的)

2020年12月29日

上次提交的符合 QC 标准的更新

2020年12月28日

最后验证

2020年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RECHMPL20_0197

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

NC

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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