COVID-19 and Mental Health in Eure

NCT05364060 | Unknown

• 2 other identifiers: 2021-A01280-41CHES N°21/02
• Study Type: observational
• Target: 585
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19 Pandemic; Psychiatric Disorder

Keywords

covid-19; psychiatry

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline

Secondary Outcomes (4)

• Describe population characteristics

  Baseline

• Evaluation of sleep disorder

  Baseline

• Evaluation of post-traumatic stress disorder

  Baseline

• Evaluation of positive and negative thoughts

  Baseline

Study Arms (1)

patients followed in psychiatry

Quantitative questionnaires

Other: Questionnaires

Interventions

Questionnaires OTHER

Different questionnaires detailed in the objectives part

patients followed in psychiatry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Eure-Seine: lead
• New Hospital of Navarre: collaborator

Study Sites (1)

CH Eure-Seine

Évreux, 27015, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Mental Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tarik Mazouzi, MD

  New Hospital of Navarre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sorina Mihailescu, MD

CONTACT

+33232338833; sorina-dana.mihailescu@ch-eureseine.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 6, 2022
• Study Start: June 13, 2022
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)