COVID-19 and Mental Health in Eure

COVID-19 Pandemic Clinical Trial

— COVID-SME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364060
• Other study ID #: 2021-A01280-41
• Secondary ID: CHES N°21/02
• Status: Recruiting
• Start date: June 13, 2022
• Est. completion date: June 13, 2023

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Eure-Seine
• Contact: Sorina Mihailescu, MD
• Phone: +33232338833
• Email: sorina-dana.mihailescu[@]ch-eureseine.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 585
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Other:
• Questionnaires
Different questionnaires detailed in the objectives part

Locations

Country	Name	City	State
France	CH Eure-Seine	Évreux

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Eure-Seine	New Hospital of Navarre

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Describe population characteristics	Typical demographic information such as age, gender, education level, current living situation, etc, and characteristics related to COVID-19	Baseline
Secondary	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
Secondary	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
Secondary	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