EMOCOV: Post-Covid-19 Emotional Aspects of Hospital Staff

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04794920
Collaborator
(none)
780
1
29.7
26.3

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    780 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post-Covid-19 Emotional Aspects of Hospital Staff
    Actual Study Start Date :
    Jul 10, 2020
    Actual Primary Completion Date :
    Oct 3, 2020
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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). [Day 1]

      Rate of staff with a score> 44 on the PCL questionnaire

    2. 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). [Day 1]

      Rate of staff with a score ≥11 on items A and D for the HAD score

    Secondary Outcome Measures

    1. Look for demographic and professional characteristics that may favor the onset of these symptoms [Day 1]

      Univariate and multivariate analyzes to identify the risk factors for the occurrence of these symptoms (anxiety, depression and post-traumatic stress)

    2. Evaluate the impact of frequentation of the staff bubble on the occurrence of anxiety / depressive disorders [Day 1]

      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.

    3. Evaluate the impact of frequentation of the staff bubble on the occurrence of post-traumatic stress [Day 1]

      Difference between the mean PCL scores between the 2 above-mentioned groups

    4. Evaluate the impact of the psychological support unit on the occurrence of anxiety / depressive disorders [Day 1]

      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.

    5. Evaluate the impact of the psychological support unit on the occurrence of post traumatic stress [Day 1]

      Difference between the mean PCL scores between the 2 above-mentioned groups

    6. Evaluate the benefit felt by staff from frequenting the staff bubble [Day 1]

      In the group "frequentation of the staff bubble": percentage of response "Very beneficial" or "Quite beneficial"

    7. Evaluate the benefit felt by the staff of the meeting with the psychological support unit [Day 1]

      In the group "meeting with the psychological support unit": percentage of response "Very beneficial" or "Quite beneficial"

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris Ile De France France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: Marguerite D'USSEL, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT04794920
    Other Study ID Numbers:
    • EMOCOV
    First Posted:
    Mar 12, 2021
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Groupe Hospitalier Paris Saint Joseph
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022