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Completed

NCT Number: NCT04430049

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

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)

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Key information

Conditions

COVID-19 Anxiety Disorders Behavior Behavioral Symptoms Coronaviridae Infections Coronavirus Infections Critical Illness Depression Disease Attributes Family Members Infections Lung Diseases Mental Disorders Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital, Clermont-Ferrand, Clermont-Ferrand, Auvergne, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Covid ICU containment measures

Procedure

The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU

Primary outcomes

  1. Anxiety

    Time frame: Between 3 and 6 months

    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.

  2. Depression

    Time frame: Between 3 and 6 months

    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.

Secondary outcomes

  1. post-traumatic stress disorder

    Time frame: between 3 and 6 months

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: HAD-Covid

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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