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Clinical Trials/NCT05364060
NCT05364060
Recruiting
Not Applicable

Assessment of Severe Depression Related to Psychotrauma in the COVID-19 Context in Patients Followed in Psychiatry in the Department of Eure

Centre Hospitalier Eure-Seine1 site in 1 country585 target enrollmentJune 13, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 Pandemic
Sponsor
Centre Hospitalier Eure-Seine
Enrollment
585
Locations
1
Primary Endpoint
Evaluation of prevalence of severe depression in patients followed in psychiatry in the department of Eure
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Research Hypothesis: Living conditions during COVID-19, and lockdowns and curfews impact the psychological state of patients (assessed by the degree of depression, positive and negative thoughts, insomnia, state of post-traumatic stress).

Detailed Description

From the early stages of the COVID-19 pandemic, concerns were raised about its effect on mental health and on patients with mental illness. Several surveys and cross-sectional assessments, in Italy, England, Ecuador and China in 2020, have suggested that patients with COVID-19 have symptoms of anxiety (including stress disorder traumatic, depression and insomnia. In France, a survey by "Santé Publique France" on the impact of COVID-19 on mental health carried out in November 2020, revealed a 20% rate of depressive symptoms in the general population. The objective of this study is to assess the level of psychological distress and the prevalence of psychiatric disorders related to COVID-19 as part of the follow-up of psychiatric patients in the department of Eure since March 2020, which has coincided with the onset of the health crisis, including consecutive lockdowns and curfews.

Registry
clinicaltrials.gov
Start Date
June 13, 2022
End Date
June 13, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Eure-Seine
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least 18 years old
  • Coming for a psychiatric consultation or hospitalization at the New Hospital of Navarre or in the extra-hospital centers of the department of Eure
  • Patient who has received the information note and who does not refuse to participate in the study

Exclusion Criteria

  • Patient not understanding French
  • Patient followed in psychiatry for a major cognitive disorder
  • Patient under legal protection measure (guardianship, curatorship, safeguard of justice, future protection mandate or family authorization)

Outcomes

Primary Outcomes

Evaluation of prevalence of severe depression in patients followed in psychiatry in the department of Eure

Time Frame: Baseline

The scale used is BDI-FS-Fr (Beck Depression Inventory-Fast Screen-French) scale, composed of seven self-assessment items taken from the 21 items of the BDI-II. The BDI-FS-Fr has been validated in France.

Secondary Outcomes

  • Describe population characteristics(Baseline)
  • Evaluation of sleep disorder(Baseline)
  • Evaluation of post-traumatic stress disorder(Baseline)
  • Evaluation of positive and negative thoughts(Baseline)

Study Sites (1)

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