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Completed

NCT Number: NCT04357418

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

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.

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Key information

Conditions

Anxiety State Anxiety Disorders Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Depression Health Personnel Attitude Infections Isolation, Social Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Social Behavior Social Isolation Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

URC Ville Evrard

Neuilly-sur-Marne, 93330, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

it is a survey

Other

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

Primary outcomes

  1. State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)

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

    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.

  2. State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)

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

    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.

Secondary outcomes

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

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

    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".

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

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

    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".

  3. Beck Depression Inventory

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

    The tool provides a quantitative estimate of the intensity of depressive feelings.

  4. Beck Depression Inventory

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

    The tool provides a quantitative estimate of the intensity of depressive feelings.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de Ville-Evrard, France

Other

Registry information

Official study title

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

Acronym: ICOS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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