COVID-19 Clinical Trial
— ICOSOfficial title:
Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)
NCT number | NCT04357418 |
Other study ID # | 10477M-ICOS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2020 |
Est. completion date | June 30, 2020 |
Verified date | July 2020 |
Source | Centre hospitalier de Ville-Evrard, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 187 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | URC Ville Evrard | Neuilly-sur-Marne |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de Ville-Evrard, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | Visual numeric scales assessing anger and stress the ongoing week. | 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". | Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020) | |
Secondary | Visual numeric scales assessing anger and stress the ongoing week. | 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". | Up to one month and a half after the end of the lockdown (from May 11th to June 25th) | |
Secondary | Beck Depression Inventory | The tool provides a quantitative estimate of the intensity of depressive feelings. | Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020) | |
Secondary | Beck Depression Inventory | The tool provides a quantitative estimate of the intensity of depressive feelings. | Up to one month and a half after the end of the lockdown (from May 11th to June 25th) |
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