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临床试验/NCT04405362
NCT04405362撤回不适用

Consequences of the QUARANTINE Relating to the COvid-19 Epidemic on the Mental Health of the Patients Followed in PSYchiatry

University Hospital, Lille0 个研究点目标入组 753 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
753
主要终点
Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine

研究概览

简要总结

Quarantine related to the Covid-19 pandemic has begun on the 03/17/2020 in France. Quarantine has already be linked to pejorative effects on mental health. In this study, we aim to evaluated PTSD symptoms of patients already followed by a psychiatrist during quarantine, one month and 3 months after inclusion. It will be also evaluate various psychiatric symptoms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients already followed in psychiatry before quarantine by one of the psychiatrists subscribed to L'Encéphale online.

排除标准

  • Refusal to complete the questionnaire

结局指标

主要结局

Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine

时间窗: at 3 months after inclusion

PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) (6). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.

次要结局

  • Total score Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)(at inclusion, then at 1 month and 3 months after inclusion)
  • IES-R (Impact of Events Scale Revised)(at inclusion, then at 1 month and 3 months after inclusion)
  • Total score at BDI (Beck Depression Inventory)(at inclusion, then at 1 month and 3 months after inclusion)
  • Total score at ISI (Insomnia Severity Index)(at inclusion, then at 1 month and 3 months after inclusion)
  • Changes in alcohol and/or cannabis consumption during and at the end of the quarantine period(at inclusion, then at 1 month and 3 months after inclusion)
  • Socio-demographic factors significantly associated with all scores(at inclusion, then at 1 month and 3 months after inclusion)
  • Presence of suicidal ideation during the past month at the different times of the study(at inclusion, then at 1 month and 3 months after inclusion)
  • Total score at GHQ-28 (General Health Questionnaire)(at inclusion, then at 1 month and 3 months after inclusion)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

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