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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

Tracking Information
First Submitted Date April 16, 2020
First Posted Date April 22, 2020
Last Update Posted Date August 3, 2020
Actual Study Start Date April 1, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 18, 2020)
  • 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".
  • 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".
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives
Official Title Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population is about hospital staff and close relatives
Condition
  • Anxiety State
  • COVID-19
  • Isolation, Social
  • Health Personnel Attitude
Intervention Other: it is a survey
this interview can be carried out face to face or remotely.
Study Groups/Cohorts
  • hospital staff
    Intervention: Other: it is a survey
  • close relatives.
    Intervention: Other: it is a survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 31, 2020)
187
Original Estimated Enrollment
 (submitted: April 18, 2020)
1320
Actual Study Completion Date June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04357418
Other Study ID Numbers 10477M-ICOS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Clémence ISAAC, Centre hospitalier de Ville-Evrard, France
Study Sponsor Centre hospitalier de Ville-Evrard, France
Collaborators Not Provided
Investigators
Principal Investigator: Clemence ISAAC, PhD CH Ville Evrard
Study Director: Dominique JANUEL, Pr CH Ville Evrard
PRS Account Centre hospitalier de Ville-Evrard, France
Verification Date July 2020