NCT04357418

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

April 16, 2020

Last Update Submit

July 31, 2020

Conditions

Anxiety StateCOVID-19Isolation, SocialHealth Personnel Attitude

Keywords

anxietydepressionangerquarantinehealth care workers

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Visual numeric scales assessing anger and stress the ongoing week.

    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.

    Up to one month and a half after the end of the lockdown (from May 11th to June 25th)

  • Beck Depression Inventory

    Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)

  • Beck Depression Inventory

    Up to one month and a half after the end of the lockdown (from May 11th to June 25th)

Study Arms (2)

hospital staff

Other: it is a survey

close relatives.

Other: it is a survey

Interventions

it is a surveyOTHER

this interview can be carried out face to face or remotely.

close relatives.hospital staff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population is about hospital staff and close relatives

You may qualify if:

  • 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.

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

URC Ville Evrard

Neuilly-sur-Marne, 93330, France

Location

MeSH Terms

Conditions

Anxiety DisordersCOVID-19Social IsolationDepression

Condition Hierarchy (Ancestors)

Mental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSocial BehaviorBehaviorBehavioral Symptoms

Study Officials

  • Clemence ISAAC, PhD

    CH Ville Evrard

    PRINCIPAL INVESTIGATOR

  • Dominique JANUEL, Pr

    CH Ville Evrard

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 22, 2020

Study Start

April 1, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

August 3, 2020

Record last verified: 2020-07

Locations

FR(1)