Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients

Study Overview
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Brief Summary
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To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period (2020 and 2021) with those no Covid period (2022)

Detailed Description
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Observational multicenter study Three groups are compared: no visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2020 restrictive visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2021 open visit group. Enrollment during a no Covid period without restrictive visitation: March to June 2022 The primary objective is to compare the Hospital Anxiety and Depression Scale (HADS) for relative at 3-6 months after the ICU patient discharge between the three groups The secondary objectives are to compare the Post-Traumatic Stress Disorder (PTSD) for relative at 3-6 months after the ICU patient discharge between the three groups to compare the prevalence of significant symptoms of both anxiety and depression for relative at 3-6 months after the ICU patient discharge between the three groups to compare the prevalence of significant PTSD-related symptoms for relative at 3-6 months after the ICU patient discharge between the three groups to identify the factor associated with significant symptoms of both anxiety and depression to identify the factor associated with significant PTSD-related symptoms

Official Title
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Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients

Conditions
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Covid-19, Family Members, Critical Illness

Intervention / Treatment
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* Procedure: Covid ICU containment measures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Relative of patient who was admitted in ICU and treated with invasive mechanical ventilation administration during 24hours at least. Exclusion Criteria: Relative who declines the enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no visitation group<br>relatives cannot visit ICU patient during Covid pandemic period in France | Procedure: Covid ICU containment measures<br>* The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU<br>|
| restrictive visitation group<br>relatives have restriction to visit ICU patient during Covid pandemic period in France | Procedure: Covid ICU containment measures<br>* The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU<br>|
| open visitation group<br>relatives can visit ICU patient during no Covid period in France | Procedure: Covid ICU containment measures<br>* The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient. HADS ranges from 0 to 42; higher scores indicate worse symptoms. | Between 3 and 6 months | 
| Depression | Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient. HADS ranges from 0 to 42; higher scores indicate worse symptoms. | Between 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-traumatic stress disorder | Impact of post traumatic stress disorder for relative of ICU patient will be measured with the Event scale revised (IES-R) assessed between 3 and 6 months after the ICU discharge of patient. IES-R ranges from 0 to 88; higher scores indicate worse symptoms | between 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, Family, Anxiety, Depression, Post-traumatic stress disorder, Intensive Care Unit, Visitation