<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/NCT04424771</url>
  </required_header>
  <id_info>
    <org_study_id>PTSD-COVID-19</org_study_id>
    <nct_id>NCT04424771</nct_id>
  </id_info>
  <brief_title>Post-traumatic Stress Disease in Health Workers During COVID-19 Pandemia</brief_title>
  <official_title>PTSD in Health Workers During COVID-19 Pandemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia</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 purpose of the questionnaire is to find risk factors for the development of&#xD;
      post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Number of patients with diagnosis of PTSD.</measure>
    <time_frame>Through study completion, an average of 1 months</time_frame>
    <description>PTSD consists in job burnout, including emotional exhaustion, depersonalization, and personal accomplishment.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">800</enrollment>
  <condition>COVID</condition>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Health workers</arm_group_label>
    <description>They include doctors, nurses, techinicians, biologists and other non technical inhospital workers</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Maslach Burnout Inventory (MBI)</intervention_name>
    <description>The Maslach Burnout Inventory is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout.</description>
    <arm_group_label>Health workers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population consisted of workers in health services.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  workers in health services, including phisicians, nurses, inhospital technicians and&#xD;
             biologists&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ospedale Perrino Asl Brindisi</name>
      <address>
        <city>Brindisi</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piazza della Vittoria 14 Studio medico - Ginecologia e Ostetricia</name>
      <address>
        <city>Genoa</city>
        <zip>16121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia</investigator_affiliation>
    <investigator_full_name>Simone Ferrero</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04424771
org study id: PTSD-COVID-19
nct id: NCT04424771
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the questionnaire is to find risk factors for the development of
      post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with diagnosis of PTSD.
time frame: Through study completion, an average of 1 months
description: PTSD consists in job burnout, including emotional exhaustion, depersonalization, and personal accomplishment.
arm group label: Health workers
description: They include doctors, nurses, techinicians, biologists and other non technical inhospital workers
intervention type: Behavioral
intervention name: Maslach Burnout Inventory (MBI)
description: The Maslach Burnout Inventory is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout.
arm group label: Health workers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
investigator full name: Simone Ferrero
investigator title: Principal investigator
mesh term: COVID-19
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Undecided