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

• ClinicalTrials.gov Identifier: NCT04357418
• Recruitment Status: Completed
• First Posted: April 22, 2020
• Last Update Posted: August 3, 2020
• Sponsor: Centre hospitalier de Ville-Evrard, France
• 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

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

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

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