Clinical trial NCT05364060: COVID-19 and Mental Health in Eure
Official title: Assessment of Severe Depression Related to Psychotrauma in the COVID-19 Context in Patients Followed in Psychiatry in the Department of Eure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pandemic
Psychiatric Disorder
Keywords: covid-19
psychiatry
Lead sponsor: Centre Hospitalier Eure-Seine
Sponsor class: OTHER
Collaborators: name: New Hospital of Navarre
First posted: 2022-05-06
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients coming for a psychiatric consultation or hospitalization at the New Hospital of Navarre or in the extra-hospital centers of the department of Eure

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.

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)

Primary outcomes:
measure: Evaluation of prevalence of severe depression in patients followed in psychiatry in the department of Eure
timeFrame: Baseline
Secondary outcomes:
measure: Describe population characteristics
timeFrame: Baseline
measure: Evaluation of sleep disorder
timeFrame: Baseline
measure: Evaluation of post-traumatic stress disorder
timeFrame: Baseline
measure: Evaluation of positive and negative thoughts
timeFrame: Baseline
Other outcomes:
Locations:
city: Évreux
country: France
facility: CH Eure-Seine
Study officials:
affiliation: New Hospital of Navarre
name: Tarik Mazouzi, MD
role: PRINCIPAL_INVESTIGATOR
References: