<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/NCT04436861</url>
  </required_header>
  <id_info>
    <org_study_id>Decovid</org_study_id>
    <nct_id>NCT04436861</nct_id>
  </id_info>
  <brief_title>the Health Crisis at the Healthcare Professionals, Careers and Non-careers, a Month After the Containment Period</brief_title>
  <official_title>Demonstration of the Level of Anxiety / Depression of Healthcare Professionals and Non-healthcare Professionals One Month After the Confinement Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Medipole Garonne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique Medipole Garonne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator wish to study, at a distance from the lifting of confinement (1 month),&#xD;
      whether the psychological impact on professionals in nursing and non-nursing care&#xD;
      establishments is associated with their living context (professional and personal situation)&#xD;
      during confinement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The context of confinement and of the global pandemic is a major source of stress for the&#xD;
      entire population: separation of loved ones, loss of freedom, uncertainty about the&#xD;
      infectious status, boredom. All of these factors can cause negative mental health&#xD;
      consequences. Having little social contact was one of the factors increasing the negative&#xD;
      psychological impact of confinement.&#xD;
&#xD;
      People suffering from psychological disorders are particularly vulnerable during quarantine&#xD;
      periods. On March 17, 2020, the French government implemented national containment measures&#xD;
      due to the Covid-19 epidemic.&#xD;
&#xD;
      Although the effects of containment have been studied for fragile populations, no study to&#xD;
      date has focused on the specific population of healthcare facility staff. These caregivers&#xD;
      have for the most part continued their professional activity, but they have been confronted&#xD;
      with the fear of contracting or causing patients to contract Covid-19.&#xD;
&#xD;
      At a distance from the lifting of confinement (1 month), the investigator wish to study&#xD;
      whether the highlighting of anxiety or depression in these healthcare professionals is&#xD;
      associated with their context of life (professional and personal situation) during&#xD;
      confinement&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    the sponsor decided to stop the study&#xD;
  </why_stopped>
  <start_date type="Actual">June 28, 2020</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 28, 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Demonstration of the level of anxiety / depression of healthcare professionals and non-healthcare professionals one month after the confinement period</measure>
    <time_frame>1 month</time_frame>
    <description>Anxiety-depression will be assessed by the hospital anxiety and depression scalequestionnaire. The context of life during confinement will be assessed by a self-questionnaire collecting data relating to lifestyle and work.</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Psychology, Social</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We are not basing the study size on statistical arguments for this observational study. The&#xD;
        study will be offered to all healthcare professionals in order to limit bias. However, we&#xD;
        expect a minimum of 200 responses&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nursing and non-nursing care professionals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Subject included in an interventional study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04436861
org study id: Decovid
nct id: NCT04436861
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigator wish to study, at a distance from the lifting of confinement (1 month),
      whether the psychological impact on professionals in nursing and non-nursing care
      establishments is associated with their living context (professional and personal situation)
      during confinement.
The context of confinement and of the global pandemic is a major source of stress for the
      entire population: separation of loved ones, loss of freedom, uncertainty about the
      infectious status, boredom. All of these factors can cause negative mental health
      consequences. Having little social contact was one of the factors increasing the negative
      psychological impact of confinement.

      People suffering from psychological disorders are particularly vulnerable during quarantine
      periods. On March 17, 2020, the French government implemented national containment measures
      due to the Covid-19 epidemic.

      Although the effects of containment have been studied for fragile populations, no study to
      date has focused on the specific population of healthcare facility staff. These caregivers
      have for the most part continued their professional activity, but they have been confronted
      with the fear of contracting or causing patients to contract Covid-19.

      At a distance from the lifting of confinement (1 month), the investigator wish to study
      whether the highlighting of anxiety or depression in these healthcare professionals is
      associated with their context of life (professional and personal situation) during
      confinement
observational model: Cohort
time perspective: Other
measure: Demonstration of the level of anxiety / depression of healthcare professionals and non-healthcare professionals one month after the confinement period
time frame: 1 month
description: Anxiety-depression will be assessed by the hospital anxiety and depression scalequestionnaire. The context of life during confinement will be assessed by a self-questionnaire collecting data relating to lifestyle and work.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No