Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)

Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)

The purpose of the investigators is to study the psychological impact of the COVID-19 lockdown on the members of the Ville Evrard Hospital staff and their close relatives, and to identify potential lockdown conditions that could increase anxiety, anger and depressive symptoms in this population.

Study Overview

• Status: Completed
• Conditions: COVID-19; Anxiety State; Isolation, Social; Health Personnel Attitude
• Intervention / Treatment: Other: it is a survey

• Study Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• France
  • Neuilly-sur-Marne, France, 93330
    • URC Ville Evrard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population is about hospital staff and close relatives

Description

Inclusion Criteria:

• For hospital staff: Adult members of the Ville Evrard Hospital staff (trainees or employees) willing to participate to at least one survey during the COVID lockdown.
• For close relatives: Adult relatives of the Ville Evrard Hospital staff members, living or not with them.

Exclusion Criteria:

• NONE

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hospital staff	Other: it is a survey; this interview can be carried out face to face or remotely.
close relatives.	Other: it is a survey; this interview can be carried out face to face or remotely.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)	The "State Trait Inventory Anxiety" is widely used both in practice and in clinical research. It consists of separate scales for assessing state (STAI form Y-A) and trait (STAI form Y-B). Each of the scales includes 20 items, the E scale to assess how subjects feel at the time, the T scale to capture how subjects feel generally.The STAI is intended for self-administration. It can be completed individually or in a group.	Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)	The "State Trait Inventory Anxiety" is widely used both in practice and in clinical research. It consists of separate scales for assessing state (STAI form Y-A) and trait (STAI form Y-B). Each of the scales includes 20 items, the E scale to assess how subjects feel at the time, the T scale to capture how subjects feel generally.The STAI is intended for self-administration. It can be completed individually or in a group.	Up to one month and a half after the end of the lockdown (from May 11th to June 25th)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual numeric scales assessing anger and stress the ongoing week.	1 to 7 Likert scales. Anger scale going from "No anger, at no time" to "strong and sustained anger". Stress scale going from "No stress, at no time" to "strong and sustained stress".	Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
Visual numeric scales assessing anger and stress the ongoing week.	1 to 7 Likert scales. Anger scale going from "No anger, at no time" to "strong and sustained anger". Stress scale going from "No stress, at no time" to "strong and sustained stress".	Up to one month and a half after the end of the lockdown (from May 11th to June 25th)
Beck Depression Inventory	The tool provides a quantitative estimate of the intensity of depressive feelings.	Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)
Beck Depression Inventory	The tool provides a quantitative estimate of the intensity of depressive feelings.	Up to one month and a half after the end of the lockdown (from May 11th to June 25th)

Collaborators and Investigators

• Sponsor: Centre hospitalier de Ville-Evrard, France
• Investigators: Principal Investigator: Clemence ISAAC, PhD, Ch Ville Evrard; Study Director: Dominique JANUEL, Pr, Ch Ville Evrard

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2020
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 18, 2020
• First Posted (ACTUAL): April 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: depression; anxiety; anger; quarantine; health care workers
• Additional Relevant MeSH Terms: 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
• Other Study ID Numbers: 10477M-ICOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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