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临床试验/NCT04945837
NCT04945837尚未招募不适用

Psychologic Impact of COVID-19 Pandemic on the Hospital Staff of the Nouvelle Aquitaine Area : a Prospective Longitudinal Study by Self-administered Questionnaires

Centre Hospitalier Charles Perrens, Bordeaux0 个研究点目标入组 8,000 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
8,000
主要终点
Changes in anxiety disorder overcome

研究概览

简要总结

Evaluation of the psychological impact of the COVID-19 pandemic on hospital staff in the French Nouvelle Aquitaine area, through a longitudinal study with repeated self-administered psychologic scales

详细描述

Evaluation of the psychological impact of Coronavirus disease 2019 (COVID-19) on hospital personnel in Nouvelle Aquitaine. IMPSY-COV Upon recent outbreaks of new diseases (SARS, MERS-CoV, Ebola) have led to the emergence of psychiatric disorders in healthcare workers , such as post-traumatic stress , anxiety (e.g., panic attacks) or depressive episodes. Observed similarities in between propagation patterns of SARS-CoV-2 and SARS, alow us to expect the occurence of similar psychiatric disorders in COVID-19 context to those described (Vignaud, Prieto, 2020). The study is set up to assess the psychological state of hospital personnel in the working conditions of treating COVID-19 suffering patients.

87000 hospital staff workers from the Nouvelle Aquitaine region will be invited to take part in the study. This includes medical and non-medical professionals from general and psychiatric hospitals exposed to COVID-19.

Study design. The protocol shows two phases and five measurement timepoints. In the initial phase (T0), eligible persons will be contacted via email. Those wishing to participate will then consent, answer socio-demographic questions and a series of psychology questionnaires. In the longitudinal phase, participants will be again invited to answer the same series of questionnaires four times: one month after the initial phase (T1), 3 months after (T2), 6 months after (T3) and 12 months after (T4).

Statistical analysis. In order to identify the consequences generated by COVID-19 in hospital personnel through a longitudinal protocol, several statistical analyses are considered, including logistic and linear regressions as well as ANOVA and MANOVA.

Expected outcomes. The study will assess the occurrence and the evolution of psychological distress and identify vulnerability factors that may trigger psychiatric disorders in these situations. The study will also provide an opportunity to improve the supporting actions of professionals affected by the crisis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

Data anonymisation:

Participant timepoints data are identified and followed up through a token number

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

  • 18 years or more
  • hospital workers exposed to COVID-19
  • consented to participate to the study
  • master the french langage
  • Understanding of type, objectives and study methology
  • accept an on-line evaluation
  • Benefit from health insurance

排除标准

  • refuse to participate
  • pregnant or breastfeeding woman
  • Be under measure of legal protection: guardianship, curatorship or safeguard of justice.

结局指标

主要结局

Changes in anxiety disorder overcome

时间窗: inclusion, month 1, month 3, month 6, month 12

GAD-7 score: \> 7 , the anxiety disorder status is "supected", \[5; 9\] corresponds to anxiety evaluation: "light" \[10; 14\] corresponds to anxiety evaluation: "moderate" \> 15, corresponds to anxiety evaluation: "severe"

次要结局

  • Determination and collection of lived traumatic events types(inclusion, month 1, month 3, month 6, month 12)
  • Burn out diagnosis(inclusion, month 1, month 3, month 6, month 12)
  • Evaluation of the CUMP support to health professionnals(inclusion, month 1, month 3, month 6, month 12)
  • Posttraumatic stress disorder symptoms presence and measurment(inclusion, month 1, month 3, month 6, month 12)
  • 2-last-week mood assessment(inclusion, month 1, month 3, month 6, month 12)
  • Self evaluation of state of health(inclusion, month 1, month 3, month 6, month 12)
  • Identification of coping pattern to stress(inclusion, month 1, month 3, month 6, month 12)
  • Psycho active drugs intakes and level of intake over the last month(inclusion, month 1, month 3, month 6, month 12)

研究者

发起方
Centre Hospitalier Charles Perrens, Bordeaux
申办方类型
Other Gov
责任方
Sponsor

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