Completed

PSY-CO-ICUPsychological Impact of COVID-19 on ICU Caregivers

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Study Aim

The study observes the psychological impact, specifically post-traumatic stress disorder, of COVID-19 on caregivers working in intensive care units.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Trauma and Stressor Related Disorders+17

+ COVID-19

+ Mental Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2021
See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire de Nīmes
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 25, 2021

Actual date on which the first participant was enrolled.

This study focuses on understanding the psychological effects of the COVID-19 pandemic on caregivers, especially those working in Intensive Care Units (ICUs). It aims to determine how many caregivers, such as doctors and nurses who were moved to ICUs or other busy hospital areas, experience conditions like Post-Traumatic Stress Disorder (PTSD), severe depression, anxiety, and Burn-Out Syndrome (BOS) due to the stress of the pandemic. This research is important because caregivers faced significant challenges and changes in their work environment during the pandemic, which might lead to mental health issues. Finding out how widespread these issues are can help in creating better support systems for healthcare workers. Participants in this observational study include caregivers from hospitals, both those who worked in ICUs and those who did not. The study gathers information through a questionnaire called the Post-Traumatic Stress Disorder Checklist Scale (PCL-5), which helps evaluate symptoms of PTSD. By analyzing this data, researchers aim to find out how common PTSD and other mental health issues are among caregivers and identify what factors might contribute to these conditions. The findings could lead to improved mental health resources and support for healthcare professionals dealing with pandemic-related stress.

Official TitlePsychological Impact of COVID-19 Outbreak on Caregivers Involved in Intensive Care Unit Patient Management: Impact on the Occurrence of Post-traumatic Stress Disorder, Anxiety, Depression and Burn Out Syndrome
NCT04511780
Principal SponsorCentre Hospitalier Universitaire de Nīmes
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

701 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Trauma and Stressor Related DisordersCOVID-19Mental DisordersCoronaviridae InfectionsInfectionsLung DiseasesPathologic ProcessesPneumoniaPneumonia, ViralRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsStress Disorders, Post-TraumaticPathological Conditions, Signs and SymptomsVirus DiseasesCritical IllnessCoronavirus InfectionsDisease AttributesNidovirales InfectionsStress Disorders, Traumatic

Criteria

Inclusion Criteria: * Caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of ICU patients during Covid-19 outbreak * Approved to participate Exclusion Criteria: * Participation refusal * No internet connection for responding to the questionnaire with REDCAP file

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 51 locations

Suspended

AP-HP, Hôpital Henri Mondor

Créteil, FranceOpen AP-HP, Hôpital Henri Mondor in Google Maps
Suspended

CHU de dijon

Dijon, France
Suspended

CHU de Grenoble, Hôpital Michalon

La Tronche, France
Suspended

AP_HP, Hôpital du Kremlin Bicêtre

Le Kremlin-Bicêtre, France
Completed51 Study Centers