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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04511780
Collaborator
(none)
5,000
51
20
98
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire filling

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Post-Traumatic Stress Disorder [3-6 month after the Covid-19 outbreak]

    PCL - 5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5)

Secondary Outcome Measures

  1. anxiety and depression [3-6 month after the Covid-19 outbreak]

    HADS scale (Hospital Anxiety and Depression Scale)

  2. Burn out [3-6 month after the Covid-19 outbreak]

    Score MBI (Burn out syndrome)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Intensive Care Unit, CHU d'Amiens Amiens France 80054
2 Intensive Care Unit, CHU d'Angers Angers France 49933
3 CHU de Besançon Besançon France 25030
4 CHU de Bordeaux, Hôpital Pellegrin Bordeaux France 33076
5 Intensive care Unit CHU de Brest Hôpital Cavale Blanche Brest France 29609
6 CHU de Caen Caen France 14033
7 CHU de Clermont Ferrand Clermont-Ferrand France 63003
8 AP-HP, Hôpital Henri Mondor Créteil France 94010
9 CHU de dijon Dijon France 21079
10 CHU de Grenoble, Hôpital Michalon La Tronche France 38700
11 AP_HP, Hôpital du Kremlin Bicêtre Le Kremlin-Bicêtre France 94275
12 Intensive Care Unit, CHRU de Lille Lille France 59037
13 Intensive Care Unit, CHU de Limoges Limoges France 87042
14 Hôpitaux civils de Lyon, Hôpital de la Croix Rousse Lyon France 69317
15 Hôpitaux civils de Lyon, Hôpital Louis Pradel Lyon France 69394
16 Hôpitaux civils de Lyon, Hôpital Edouard Herriot Lyon France 69437
17 AP-HM, Hôpital Nord Marseille France 13005
18 AP-HM, Hôpital Timone adultes, Intensive Care Unit Marseille France 13005
19 AP-HM, Hôpital Timone adultes, Neurotraumatology Marseille France 13015
20 AP-HM, Hôpital e la Conception Marseille France 13385
21 CHU de Montpellier, Hôpital Guy de chauliac Montpellier France 34295
22 CHU de Montpellier, Hôpital Lapeyronie Montpellier France 34295
23 CHU de Montpellier, Hôpital St Eloi SAR B Montpellier France 34295
24 CHU De Montpellier, Hôpital St Eloi-DAR B Montpellier France 34295
25 CHU De Montpellier, Hôpital St Eloi Montpellier France 34295
26 Intensive Care Unit, CHU de Mulhouse Mulhouse France 68051
27 Intensive CAre Unit CHRU de Nancy, Hôpital Central Nancy France 54000
28 Intensive Care Unit, CHU de Nantes, Hôtel Dieu Nantes France 44093
29 Intensive Care Unit, CHU de Nantes Nantes France 44093
30 CHU de Nice Nice France 06000
31 Intensive care Unit CHU Nîmes Nîmes France 30029
32 AP-HP, Hôpital de la Pitié Paris France 75013
33 AP-HP, Hôpital Bichât Paris France 75018
34 AP-HP, Hôpital Lariboisière Paris France 75475
35 AP6HP, Hôpital St Loui Paris France 75475
36 AP_HP, Hôpital G Pompidou Paris France 75908
37 AP-HP, Hôpital St Antoine Paris France 75970
38 CH de Perpignan Perpignan France 66046
39 CHU de Bordeaux, Hôpital Haut Leveque Pessac France 33604
40 Intensive care Unit, Hôpitaux civils de Lyon, Lyon Sud Pierre-Bénite France 69310
41 CHU de Poitiers Poitiers France 86021
42 Intensive care Unit CHU de Rennes Rennes France 35033
43 CHU de Rouen Rouen France 76031
44 Intensive Care Unit, CHU de Nantes, Hôpital Laennec Saint-Herblain France 44800
45 CHU de St Etienne, Hôpital Nord Saint-Étienne France 42055
46 Intesive Care Unit CHRU de Strasbourg, Hôpital civil Strasbourg France 67091
47 Intesive Care Unit CHRU de Strasbourg, Hôpital Hautepierre Strasbourg France 67098
48 CHU de Toulouse Toulouse France 31059
49 Intensive care unit CHU de Tours Tours France 37044
50 Intensive CAre Unit CHRU de Nancy, Hôpital de Brabois Vandœuvre-lès-Nancy France 54511
51 CH de Vesoul Vesoul France 70014

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT04511780
Other Study ID Numbers:
  • Local/2020/JYL-03
First Posted:
Aug 13, 2020
Last Update Posted:
Dec 19, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2020