Psychological Impact of COVID-19 Outbreak on Caregivers (PSY-CO-ICU)

Psychological 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

Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. In public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of Covid-19. In this purpose, the number of available beds in Intensive Care Units (ICU) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. That means:

1. For the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in ICUs.
2. For the less severe patients, personals of non-busy units have been transferred in busier ones.

All these measures lead to major daily-life change sets that could be stressful. In the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of Post-Traumatic Stress Disorder (PTSD) syndrome in about 30% overall population. Importantly, high depressive symptoms have been reported in 9% of hospital staff. Numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms.

In hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. However, two studies reported a high prevalence of burn-out syndrome (BOS) in ICU physician and PTSD syndrome and depression in ICU nurses. As the consequences of all the measures decided and applied during Covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of PTSD syndrome in a large population of caregivers implied or not in Intensive Care Units. The secondary objective were 1) to assess the prevalence of severe depression and anxiety and BOS 2) to isolate potential factors associated with PTSD, severe depression, anxiety or BOS.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Covid19; Stress Disorders, Post-Traumatic
• Intervention / Treatment: Other: questionnaire filling

• Study Type: Observational
• Enrollment (Actual): 701

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Intensive Care Unit, CHU d'Amiens
  • Angers, France, 49933
    • Intensive Care Unit, CHU d'Angers
  • Besançon, France, 25030
    • CHU de Besancon
  • Bordeaux, France, 33076
    • CHU de Bordeaux, Hôpital Pellegrin
  • Brest, France, 29609
    • Intensive care Unit CHU de Brest Hôpital Cavale Blanche
  • Caen, France, 14033
    • CHU de Caen
  • Clermont-Ferrand, France, 63003
    • Chu de Clermont Ferrand
  • Créteil, France, 94010
    • AP-HP, Hôpital Henri Mondor
  • Dijon, France, 21079
    • Chu de Dijon
  • La Tronche, France, 38700
    • CHU de Grenoble, Hôpital Michalon
  • Le Kremlin-Bicêtre, France, 94275
    • AP_HP, Hôpital du Kremlin Bicêtre
  • Lille, France, 59037
    • Intensive Care Unit, CHRU de Lille
  • Limoges, France, 87042
    • Intensive Care Unit, CHU de Limoges
  • Lyon, France, 69317
    • Hôpitaux civils de Lyon, Hôpital de la Croix Rousse
  • Lyon, France, 69394
    • Hôpitaux civils de Lyon, Hôpital Louis Pradel
  • Lyon, France, 69437
    • Hôpitaux civils de Lyon, Hôpital Edouard Herriot
  • Marseille, France, 13005
    • AP-HM, Hôpital Nord
  • Marseille, France, 13005
    • AP-HM, Hôpital Timone adultes, Intensive Care Unit
  • Marseille, France, 13015
    • AP-HM, Hôpital Timone adultes, Neurotraumatology
  • Marseille, France, 13385
    • AP-HM, Hôpital e la Conception
  • Montpellier, France, 34295
    • CHU de Montpellier, Hôpital Guy de chauliac
  • Montpellier, France, 34295
    • CHU de Montpellier, Hôpital Lapeyronie
  • Montpellier, France, 34295
    • CHU de Montpellier, Hôpital St Eloi SAR B
  • Montpellier, France, 34295
    • CHU De Montpellier, Hôpital St Eloi-DAR B
  • Montpellier, France, 34295
    • CHU De Montpellier, Hôpital St Eloi
  • Mulhouse, France, 68051
    • Intensive Care Unit, CHU de Mulhouse
  • Nancy, France, 54000
    • Intensive CAre Unit CHRU de Nancy, Hôpital Central
  • Nantes, France, 44093
    • Intensive Care Unit, CHU de Nantes, Hôtel Dieu
  • Nantes, France, 44093
    • Intensive Care Unit, CHU de Nantes
  • Nice, France, 06000
    • CHU de Nice
  • Nîmes, France, 30029
    • Intensive care Unit CHU Nîmes
  • Paris, France, 75013
    • AP-HP, Hôpital de la Pitié
  • Paris, France, 75018
    • AP-HP, Hôpital Bichât
  • Paris, France, 75475
    • AP-HP, Hôpital Lariboisière
  • Paris, France, 75475
    • AP6HP, Hôpital St Loui
  • Paris, France, 75908
    • AP_HP, Hôpital G Pompidou
  • Paris, France, 75970
    • AP-HP, Hôpital St Antoine
  • Perpignan, France, 66046
    • CH de Perpignan
  • Pessac, France, 33604
    • CHU de Bordeaux, Hôpital Haut Leveque
  • Pierre-Bénite, France, 69310
    • Intensive care Unit, Hôpitaux civils de Lyon, Lyon Sud
  • Poitiers, France, 86021
    • Chu de Poitiers
  • Rennes, France, 35033
    • Intensive care Unit CHU de Rennes
  • Rouen, France, 76031
    • CHU de Rouen
  • Saint-Etienne, France, 42055
    • CHU de St Etienne, Hôpital Nord
  • Saint-Herblain, France, 44800
    • Intensive Care Unit, CHU de Nantes, Hôpital Laennec
  • Strasbourg, France, 67091
    • Intesive Care Unit CHRU de Strasbourg, Hôpital civil
  • Strasbourg, France, 67098
    • Intesive Care Unit CHRU de Strasbourg, Hôpital Hautepierre
  • Toulouse, France, 31059
    • CHU de Toulouse
  • Tours, France, 37044
    • Intensive care unit CHU de Tours
  • Vandœuvre-lès-Nancy, France, 54511
    • Intensive CAre Unit CHRU de Nancy, Hôpital de Brabois
  • Vesoul, France, 70014
    • CH de Vesoul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Caregivers; • 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	Other: questionnaire filling; assessment of post-traumatic stress, anxiety and burn out

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Traumatic Stress Disorder	PCL - 5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5)	3-6 month after the Covid-19 outbreak

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety and depression	HADS scale (Hospital Anxiety and Depression Scale)	3-6 month after the Covid-19 outbreak
Burn out	Score MBI (Burn out syndrome)	3-6 month after the Covid-19 outbreak

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jean Yves LEFRANT, Centre Hospitalier Universitaire de Nimes

Publications and helpful links

General Publications

• Roger C, Ling L, Petrier M, Elotmani L, Atchade E, Allaouchiche B, Aubrun F, Constantin JM, Dahyot-Fizelier C, Delhaye N, Dupont H, Fischer MO, Garnier M, Gayat E, Ichai C, Jaber S, Morel J, Plaud B, Rimmele T, Robin S, Saba R, Joynt GM, Lefrant JY, Fabbro-Peray P, Lipman J, Conejero I, Laupland K. Occurrences of post-traumatic stress disorder, anxiety, depression, and burnout syndrome in ICU staff workers after two-year of the COVID-19 pandemic: the international PSY-CO in ICU study. Ann Gen Psychiatry. 2024 Jan 3;23(1):3. doi: 10.1186/s12991-023-00488-5.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Stress Disorders, Traumatic; Pathological Conditions, Signs and Symptoms; COVID-19; Critical Illness; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Local/2020/JYL-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No