<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04441476</url>
  </required_header>
  <id_info>
    <org_study_id>QUENOT SERI 2020</org_study_id>
    <nct_id>NCT04441476</nct_id>
  </id_info>
  <brief_title>Ethical and Psychological Support for Health Care Professions in Intensive Care Units in the COVID19 Pandemic Context: Adequacy With Needs and Psychological Impact Crisis and Post-crisis</brief_title>
  <acronym>PsyCOVID</acronym>
  <official_title>Ethical and Psychological Support for Health Care Professions in Intensive Care Units in the COVID19 Pandemic Context: Adequacy With Needs and Psychological Impact Crisis and Post-crisis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The intensive care unit occupies a particular place in our health care system. The urgency of&#xD;
      the clinical situations, the proportion of deaths encountered, and the daily workload is&#xD;
      likely to generate suffering among staff. The health crisis linked to SARS-COV-2 is&#xD;
      unprecedented and has leads to the unprecedented mobilisation of care providers, particularly&#xD;
      in the ICU. Faced with the massive and growing influx of patients, human, therapeutic and&#xD;
      material resources are overwhelmed and the teams are faced with an unusually heavy workload&#xD;
      in a context of extreme tension. These professionals are thus exposed to a risk of&#xD;
      over-investment, in a context of acute and repetitive stress, over an indeterminate period of&#xD;
      time combining workload, emotional intensity with specific ethical issues, simultaneously&#xD;
      affecting the professional sphere but also the personal and family sphere (confinement, risk&#xD;
      of contamination). Now more than ever, the mental health of caregivers is an important&#xD;
      concern, as highlighted by the CCNE. Mental health is understood in the way in which the&#xD;
      individual responds specifically to work-related suffering by developing individual and&#xD;
      collective defensive strategies. Thus, the issue of mental health in the ICU cannot be&#xD;
      considered without taking into account the strategies that professionals put in place to&#xD;
      combat stress and to contribute or not to the construction and stabilization of the work&#xD;
      collective (collaboration, support). Ethical and/or psychological support systems have been&#xD;
      set up in most of the establishments involved in the care of Covid-19 patients. However, the&#xD;
      adequacy of these systems relative to the needs of professionals during and after the crisis&#xD;
      is not yet known. We hypothesize that the psychological and social repercussions of this&#xD;
      pandemic as well as the individual and collective strategies deployed by ICU care providers&#xD;
      to deal with it will evolve in view of the progression of the crisis but also of the various&#xD;
      types of support, particularly psychological and/or ethical, available to them.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 21, 2020</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 21, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PS-ICU Scale Score</measure>
    <time_frame>Through study completion, an average of 6 months after the epidemic peak</time_frame>
    <description>This scale integrates generic stressors as well as factors specific to intensive care and crises.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3080</enrollment>
  <condition>Psychological Strain</condition>
  <arm_group>
    <arm_group_label>ICU staff</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>An online questionnaire (Limesurvey platform) will be made available at 4 different times (M0, M1, M2 and M6).&#xD;
The first questionnaires (M0 and M1) will include a component for professional characterization. Generic and specific stress factors related to ICU and the current pandemic and collective and individual defensive strategies will also be collected in M0 and M1.&#xD;
At M2 and M6, the traumatic impact of the crisis, burnout, signs of depression and recourse to internal or external support in the department (occupational medicine, support unit) will be collected.</description>
    <arm_group_label>ICU staff</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>psychological and sociological interviews</intervention_name>
    <description>conducting semi-directive psychological interviews (40 interviews in M2, 40 interviews in M6).&#xD;
sociological interviews: 40 (20 in M1-M2 then 20 in M6) in order to understand the consequences of the epidemic on daily life, both intra-family and micro-social.</description>
    <arm_group_label>ICU staff</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        nursing staff in French hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study population is the entire ICU staff of the participating centres, whether&#xD;
             they are permanently or transiently assigned to these units and/or the institution,&#xD;
             whether they are students or not.&#xD;
&#xD;
        Professionals involved in psychological and ethical support structures may also be&#xD;
        interviewed to provide the information necessary to describe and evaluate the organisations&#xD;
        and their evolution.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04441476
org study id: QUENOT SERI 2020
nct id: NCT04441476
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The intensive care unit occupies a particular place in our health care system. The urgency of
      the clinical situations, the proportion of deaths encountered, and the daily workload is
      likely to generate suffering among staff. The health crisis linked to SARS-COV-2 is
      unprecedented and has leads to the unprecedented mobilisation of care providers, particularly
      in the ICU. Faced with the massive and growing influx of patients, human, therapeutic and
      material resources are overwhelmed and the teams are faced with an unusually heavy workload
      in a context of extreme tension. These professionals are thus exposed to a risk of
      over-investment, in a context of acute and repetitive stress, over an indeterminate period of
      time combining workload, emotional intensity with specific ethical issues, simultaneously
      affecting the professional sphere but also the personal and family sphere (confinement, risk
      of contamination). Now more than ever, the mental health of caregivers is an important
      concern, as highlighted by the CCNE. Mental health is understood in the way in which the
      individual responds specifically to work-related suffering by developing individual and
      collective defensive strategies. Thus, the issue of mental health in the ICU cannot be
      considered without taking into account the strategies that professionals put in place to
      combat stress and to contribute or not to the construction and stabilization of the work
      collective (collaboration, support). Ethical and/or psychological support systems have been
      set up in most of the establishments involved in the care of Covid-19 patients. However, the
      adequacy of these systems relative to the needs of professionals during and after the crisis
      is not yet known. We hypothesize that the psychological and social repercussions of this
      pandemic as well as the individual and collective strategies deployed by ICU care providers
      to deal with it will evolve in view of the progression of the crisis but also of the various
      types of support, particularly psychological and/or ethical, available to them.
observational model: Cohort
time perspective: Prospective
measure: PS-ICU Scale Score
time frame: Through study completion, an average of 6 months after the epidemic peak
description: This scale integrates generic stressors as well as factors specific to intensive care and crises.
arm group label: ICU staff
intervention type: Other
intervention name: Questionnaires
description: An online questionnaire (Limesurvey platform) will be made available at 4 different times (M0, M1, M2 and M6).
The first questionnaires (M0 and M1) will include a component for professional characterization. Generic and specific stress factors related to ICU and the current pandemic and collective and individual defensive strategies will also be collected in M0 and M1.
At M2 and M6, the traumatic impact of the crisis, burnout, signs of depression and recourse to internal or external support in the department (occupational medicine, support unit) will be collected.
arm group label: ICU staff
intervention type: Other
intervention name: psychological and sociological interviews
description: conducting semi-directive psychological interviews (40 interviews in M2, 40 interviews in M6).
sociological interviews: 40 (20 in M1-M2 then 20 in M6) in order to understand the consequences of the epidemic on daily life, both intra-family and micro-social.
arm group label: ICU staff
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19