Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04794920
Other study ID # EMOCOV
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 10, 2020
Est. completion date January 9, 2023

Study information

Verified date April 2023
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The ongoing SARS-CoV2 or Covid-19 pandemic is causing a major global health crisis. In France, it prompted an urgent reorganization of the healthcare supply, mobilizing caregivers and hospital staff in a climate of uncertainty. Health services have been put to the test, some staff being on the front line, others having faced the reorganization of the health system necessitated by such a pandemic. Frontline caregivers have been compared to "fighters on the front lines." They encountered many difficulties, such as direct exposure to patients with a high viral load, exposure to the risk of contamination, physical exhaustion, reorganization of workspaces, adaptation to rigid work organizations, the management of the shortage of materials, the unusually high number of deaths among patients, colleagues or relatives, ethical questions relating to decision-making in a strained healthcare system. The psychological impact on these hospital staff is an indirect issue of such a pandemic in terms of mental health. The investigators have little data in the literature on the incidence of psychiatric episodes in the post-epidemic period. Work on the impact of two major pandemics of influenza A H1N1 (2009) and SARS-CoV-1 (2003) on the mental health of caregivers and other staff working in hospitals reports increased rates of mental disorders after discharge from anxiety-type crisis, depression and post-traumatic stress. This over-representation of mental disorders was still found several years after the epidemic. Similar results are emerging in recent studies involving hospital staff who were used in the Covid-19 crisis. These highlight a certain number of risk factors for the occurrence of these disorders (young age, nursing profession, underlying psychiatric pathology, exercise carried out in the first line of Covid).


Description:

At the Paris Saint-Joseph Hospital Group (GHPSJ), a multidisciplinary working group was early involved in psychological support for staff. This group proposed the establishment of on-call duty entrusted to a psychological support unit, made up of a doctor, a nurse and a psychologist who volunteered to carry out patrols in the various departments of the hospital. These visits, sometimes organized at the request of the management of the services and sometimes improvised, aimed to identify the difficulties encountered in the field, and to discuss with the teams. Concomitantly and complementary, the staff bubble opened at the Paris Saint-Joseph Hospital on March 27, to offer a decompression space to all staff (caregivers or not) with proposals for hypnosis, physiotherapy, sophrology sessions. , psychotherapy, but also informal discussions or a break in a relaxing armchair. As a continuation of this approach, the multidisciplinary working group plans to search in July 2020 for symptoms present in certain mental illnesses (anxiety, depression, post-traumatic stress syndrome) in all the staff of the Paris Saint-Joseph Hospital Group. , now that the crisis seems to be receding. This will make it possible to adapt the support offer for staff in the coming months. This inventory will be made on the basis of validated questionnaires: the Posttraumatic stress disorder CheckList-5 (PCL) questionnaire for post-traumatic stress and the Hospital Anxiety and Depression scale (HAD) score for mental disorders (anxiety, depression) . A 3rd questionnaire will collect additional data and provide feedback on the frequentation of the bubble


Recruitment information / eligibility

Status Completed
Enrollment 780
Est. completion date January 9, 2023
Est. primary completion date October 3, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any staff (caregivers and non-carers) who worked during the Covid 19 crisis (from March 15 to May 15) at the GHPSJ, on site or by teleworking, all or part of the period. Exclusion Criteria: - Opposition to participate in research.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Groupe Hospitalier Paris Saint-Joseph Paris Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (1)

d'Ussel M, Fels A, Durand X, Lemogne C, Chatellier G, Castreau N, Adam F. Factors associated with psychological symptoms in hospital workers of a French hospital during the COVID-19 pandemic: Lessons from the first wave. PLoS One. 2022 Apr 28;17(4):e02670 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of symptoms related to post-traumatic stress in all staff who worked at the GHPSJ during the crisis (from March 15 to May 15, 2020). Rate of staff with a score> 44 on the PCL questionnaire Day 1
Primary Frequency of symptoms related to post-traumatic stress in all staff who worked at the GHPSJ during the crisis (from March 15 to May 15, 2020). Rate of staff with a score =11 on items A and D for the HAD score Day 1
Secondary Look for demographic and professional characteristics that may favor the onset of these symptoms Univariate and multivariate analyzes to identify the risk factors for the occurrence of these symptoms (anxiety, depression and post-traumatic stress) Day 1
Secondary Evaluate the impact of frequentation of the staff bubble on the occurrence of anxiety / depressive disorders Difference between the average HAD scores between the group "frequentation of the staff bubble" and the group "non-attendance of the staff bubble". The distinction between the 2 groups is made on the basis of their answer to the dedicated question asked in the questionnaire. Day 1
Secondary Evaluate the impact of frequentation of the staff bubble on the occurrence of post-traumatic stress Difference between the mean PCL scores between the 2 above-mentioned groups Day 1
Secondary Evaluate the impact of the psychological support unit on the occurrence of anxiety / depressive disorders Difference between the average HAD scores between the "contact with the psychological support unit" group and the "no contact with the psychological support unit" group. The distinction between the 2 groups is made on the basis of their response to the question asked in the questionnaire. Day 1
Secondary Evaluate the impact of the psychological support unit on the occurrence of post traumatic stress Difference between the mean PCL scores between the 2 above-mentioned groups Day 1
Secondary Evaluate the benefit felt by staff from frequenting the staff bubble In the group "frequentation of the staff bubble": percentage of response "Very beneficial" or "Quite beneficial" Day 1
Secondary Evaluate the benefit felt by the staff of the meeting with the psychological support unit In the group "meeting with the psychological support unit": percentage of response "Very beneficial" or "Quite beneficial" Day 1
See also
  Status Clinical Trial Phase
Completed NCT05047692 - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 1
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Completed NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Completed NCT04961541 - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine Phase 1/Phase 2
Active, not recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Terminated NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Terminated NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Not yet recruiting NCT04527211 - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Phase 3
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Active, not recruiting NCT06042855 - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) Phase 3