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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04511780
Recruitment Status : Not yet recruiting
First Posted : August 13, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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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
Critical Illness Covid19 Stress Disorders, Post-Traumatic Other: questionnaire filling

Study Design
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Study Type : Observational
Estimated 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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Post-Traumatic Stress Disorder [ Time Frame: 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 [ Time Frame: 3-6 month after the Covid-19 outbreak ]
    HADS scale (Hospital Anxiety and Depression Scale)

  2. Burn out [ Time Frame: 3-6 month after the Covid-19 outbreak ]
    Score MBI (Burn out syndrome)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511780


Contacts
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Contact: Jean Yves LEFRANT +33466683331 jean.yves.lefrant@chu-nimes.fr

Locations
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Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Jean Yves LEFRANT Centre Hospitalier Universitaire de Nīmes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04511780    
Other Study ID Numbers: Local/2020/JYL-03
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Critical Illness
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Trauma and Stressor Related Disorders
Mental Disorders
Disease Attributes
Pathologic Processes