Psychological Impact of COVID-19 Outbreak on Caregivers

NCT ID: NCT04511780

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 701 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-25
• Study Completion Date: 2022-07-20

Brief Summary

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.

Conditions

Critical Illness; Covid19; Stress Disorders, Post-Traumatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

questionnaire filling

Intervention Type: OTHER

assessment of post-traumatic stress, anxiety and burn out

Interventions

questionnaire filling

assessment of post-traumatic stress, anxiety and burn out

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Yves LEFRANT

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nīmes

Locations

Intensive Care Unit, CHU d'Amiens

Amiens, , France

Intensive Care Unit, CHU d'Angers

Angers, , France

CHU de Besançon

Besançon, , France

CHU de Bordeaux, Hôpital Pellegrin

Bordeaux, , France

Intensive care Unit CHU de Brest Hôpital Cavale Blanche

Brest, , France

CHU de Caen

Caen, , France

CHU de Clermont Ferrand

Clermont-Ferrand, , France

AP-HP, Hôpital Henri Mondor

Créteil, , France

CHU de dijon

Dijon, , France

CHU de Grenoble, Hôpital Michalon

La Tronche, , France

AP_HP, Hôpital du Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Intensive Care Unit, CHRU de Lille

Lille, , France

Intensive Care Unit, CHU de Limoges

Limoges, , France

Hôpitaux civils de Lyon, Hôpital de la Croix Rousse

Lyon, , France

Hôpitaux civils de Lyon, Hôpital Louis Pradel

Lyon, , France

Hôpitaux civils de Lyon, Hôpital Edouard Herriot

Lyon, , France

AP-HM, Hôpital Nord

Marseille, , France

AP-HM, Hôpital Timone adultes, Intensive Care Unit

Marseille, , France

AP-HM, Hôpital Timone adultes, Neurotraumatology

Marseille, , France

AP-HM, Hôpital e la Conception

Marseille, , France

CHU de Montpellier, Hôpital Guy de chauliac

Montpellier, , France

CHU de Montpellier, Hôpital Lapeyronie

Montpellier, , France

CHU de Montpellier, Hôpital St Eloi SAR B

Montpellier, , France

CHU De Montpellier, Hôpital St Eloi-DAR B

Montpellier, , France

CHU De Montpellier, Hôpital St Eloi

Montpellier, , France

Intensive Care Unit, CHU de Mulhouse

Mulhouse, , France

Intensive CAre Unit CHRU de Nancy, Hôpital Central

Nancy, , France

Intensive Care Unit, CHU de Nantes, Hôtel Dieu

Nantes, , France

Intensive Care Unit, CHU de Nantes

Nantes, , France

CHU de Nice

Nice, , France

Intensive care Unit CHU Nîmes

Nîmes, , France

AP-HP, Hôpital de la Pitié

Paris, , France

AP-HP, Hôpital Bichât

Paris, , France

AP-HP, Hôpital Lariboisière

Paris, , France

AP6HP, Hôpital St Loui

Paris, , France

AP_HP, Hôpital G Pompidou

Paris, , France

AP-HP, Hôpital St Antoine

Paris, , France

CH de Perpignan

Perpignan, , France

CHU de Bordeaux, Hôpital Haut Leveque

Pessac, , France

Intensive care Unit, Hôpitaux civils de Lyon, Lyon Sud

Pierre-Bénite, , France

CHU de Poitiers

Poitiers, , France

Intensive care Unit CHU de Rennes

Rennes, , France

CHU de Rouen

Rouen, , France

CHU de St Etienne, Hôpital Nord

Saint-Etienne, , France

Intensive Care Unit, CHU de Nantes, Hôpital Laennec

Saint-Herblain, , France

Intesive Care Unit CHRU de Strasbourg, Hôpital civil

Strasbourg, , France

Intesive Care Unit CHRU de Strasbourg, Hôpital Hautepierre

Strasbourg, , France

CHU de Toulouse

Toulouse, , France

Intensive care unit CHU de Tours

Tours, , France

Intensive CAre Unit CHRU de Nancy, Hôpital de Brabois

Vandœuvre-lès-Nancy, , France

CH de Vesoul

Vesoul, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 38172994 (View on PubMed)

Other Identifiers

Local/2020/JYL-03

Identifier Type: -

Identifier Source: org_study_id