Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04357418
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Clémence ISAAC, Centre hospitalier de Ville-Evrard, France

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.

Condition or disease Intervention/treatment
Anxiety State COVID-19 Isolation, Social Health Personnel Attitude Other: it is a survey

Layout table for study information
Study Type : Observational
Actual Enrollment : 187 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population is about hospital staff and close relatives
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357418


Locations
Layout table for location information
France
URC Ville Evrard
Neuilly-sur-Marne, France, 93330
Sponsors and Collaborators
Centre hospitalier de Ville-Evrard, France
Investigators
Layout table for investigator information
Principal Investigator: Clemence ISAAC, PhD CH Ville Evrard
Study Director: Dominique JANUEL, Pr CH Ville Evrard
Layout table for additonal information
Responsible Party: Clémence ISAAC, Psychologist, Centre hospitalier de Ville-Evrard, France
ClinicalTrials.gov Identifier: NCT04357418    
Other Study ID Numbers: 10477M-ICOS
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clémence ISAAC, Centre hospitalier de Ville-Evrard, France:
anxiety
depression
anger
quarantine
health care workers