Psychological Impact of COVID-19 Outbreak on Caregivers

Covid19 Clinical Trial

— PSY-CO-ICU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04511780
• Other study ID #: Local/2020/JYL-03
• Status: Not yet recruiting
• Start date: January 2021
• Est. completion date: September 2022

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Jean Yves LEFRANT
• Phone: +33466683331
• Email: jean.yves.lefrant[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Critical Illness
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• questionnaire filling
assessment of post-traumatic stress, anxiety and burn out

Locations

Country	Name	City	State
France	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 Edouard Herriot	Lyon
France	Hôpitaux civils de Lyon, Hôpital Louis Pradel	Lyon
France	AP-HM, Hôpital e la Conception	Marseille
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	CHU de Montpellier, Hôpital Guy de chauliac	Montpellier
France	CHU de Montpellier, Hôpital Lapeyronie	Montpellier
France	CHU De Montpellier, Hôpital St Eloi	Montpellier
France	CHU de Montpellier, Hôpital St Eloi SAR B	Montpellier
France	CHU De Montpellier, Hôpital St Eloi-DAR B	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	Nantes
France	Intensive Care Unit, CHU de Nantes, Hôtel Dieu	Nantes
France	CHU de Nice	Nice
France	Intensive care Unit CHU Nîmes	Nîmes
France	AP-HP, Hôpital Bichât	Paris
France	AP-HP, Hôpital de la Pitié	Paris
France	AP-HP, Hôpital Lariboisière	Paris
France	AP-HP, Hôpital St Antoine	Paris
France	AP_HP, Hôpital G Pompidou	Paris
France	AP6HP, Hôpital St Loui	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-Étienne
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Traumatic Stress Disorder	PCL - 5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5)	3-6 month after the Covid-19 outbreak
Secondary	anxiety and depression	HADS scale (Hospital Anxiety and Depression Scale)	3-6 month after the Covid-19 outbreak
Secondary	Burn out	Score MBI (Burn out syndrome)	3-6 month after the Covid-19 outbreak