COVID-19 and Mental Health in Eure (COVID-SME)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Psychiatric Disorder; COVID-19 Pandemic
• Intervention / Treatment: Other: Questionnaires

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.

• Study Type: Observational
• Enrollment (Anticipated): 585

Contacts and Locations

• Study Contact: Name: Sorina Mihailescu, MD; Phone Number: +33232338833; Email: sorina-dana.mihailescu@ch-eureseine.fr

Study Locations

• France
  • Évreux, France, 27015
    • Recruiting
    • CH Eure-Seine
    • Contact: Sorina Mihailescu, MD; Phone Number: +33232338833; Email: sorina-dana.mihailescu@ch-eureseine.fr
    • Principal Investigator: Tarik Mazouzi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients followed in psychiatry; Quantitative questionnaires	Other: Questionnaires; Different questionnaires detailed in the objectives part

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe population characteristics	Typical demographic information such as age, gender, education level, current living situation, etc, and characteristics related to COVID-19	Baseline
Evaluation of sleep disorder	It will be effectuated via the Insomnia Severity Index (ISI) that is a self-reported measure assessing the subjective symptoms and consequences of insomnia, as well as the degree of worry or distress caused by sleep difficulties. The French version of the ISI has also been validated.	Baseline
Evaluation of post-traumatic stress disorder	The evaluation of post-traumatic stress disorder is performed via the SPAN (Startle, Physiological arousal, Anger, and Numbness) scale. The SPAN is a four-item scale for post-traumatic stress disorder that was empirically derived from the DTS (Davidson Trauma Scale). The minimum value for this scale is 0, the maximum, 16. Higher scores mean a worse outcome.	Baseline
Evaluation of positive and negative thoughts	Both positive and negative thoughts will be assessed using two positive and negative thought screening thermometers. Scoring is calculated from 0 to 10 for each scale.	Baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Eure-Seine
• Collaborators: New Hospital of Navarre
• Investigators: Principal Investigator: Tarik Mazouzi, MD, New Hospital of Navarre

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Anticipated): June 13, 2023
• Study Completion (Anticipated): June 13, 2023

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: covid-19; psychiatry
• Additional Relevant MeSH Terms: Behavioral Symptoms; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Problem Behavior; Mental Disorders
• Other Study ID Numbers: 2021-A01280-41; CHES N°21/02 (Other Identifier: CH Eure-Seine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No