<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/NCT03770156</url>
  </required_header>
  <id_info>
    <org_study_id>NI18012J</org_study_id>
    <secondary_id>2017-A01382-51</secondary_id>
    <nct_id>NCT03770156</nct_id>
  </id_info>
  <brief_title>Terrorist Attack - Continuity of Care</brief_title>
  <acronym>CUMP75</acronym>
  <official_title>Attentats - Continuité Des Soins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      On November 13th 2015, a terrorist attack killed 129 victims in Paris. An emergency crisis&#xD;
      unit (CUMP) has been activated in Paris in the days following the attack and a subunit was in&#xD;
      charge to answer to the phone calls of victims and their relatives. The same emergency crisis&#xD;
      unit have been activated for the terrorist attack in London, 2017 june 3, terrorist attack in&#xD;
      Barcelone 2017 august 17-18, terrorist attack in Strasbourg 2018 December 11 The purpose of&#xD;
      this observational study is to document the evolution of psychiatric symptoms among subjects&#xD;
      who called the CUMP and to collect information about the type of medical or non-medical care&#xD;
      they were seeking for.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The care of the victims of natural disasters or mass disasters such as terrorist attacks is&#xD;
      now better structured and organized. The efficacy of debriefing or of defusing has been and&#xD;
      is still debated, sometimes bitterly. The aim of the present study is not to demonstrate&#xD;
      utility or futility of such approaches, but to i) evaluate their global improvement over the&#xD;
      past three years. ii) to list the type of support that the victims were seeking in their&#xD;
      attempt to get rid of the symptoms which appeared after the terrorist attack of November 2015&#xD;
      in Paris.&#xD;
&#xD;
      iii) to collect their opinions about the way the CUMP (emergency medico-psychological unit of&#xD;
      Paris, France) managed the support to the victims.&#xD;
&#xD;
      Participating subjects registered on the occasion of their first contact with the CUMP 75 by&#xD;
      phone during the week following the attack&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2020</start_date>
  <completion_date type="Actual">October 22, 2020</completion_date>
  <primary_completion_date type="Actual">October 22, 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>Clinical Global Impression - Improvement scale (CGI-I)</measure>
    <time_frame>One day</time_frame>
    <description>Self-assessment of improvement or aggravation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Severity scale (CGI-S)</measure>
    <time_frame>One day</time_frame>
    <description>Self-assessment of symptom severity</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Post-Traumatic Stress Disorder</condition>
  <condition>Major Depressive Episode</condition>
  <arm_group>
    <arm_group_label>Subjects who contacted CUMP by phone</arm_group_label>
    <description>Subjects who contacted CUMP (Medical Psychological Emergency Cell) by phone from Paris November 13th, 2015, London 11th,2017 ; Barcelone 17-18th, 2017 ; Strasbourg 11th, 2018.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Overall Impression of the current state and evolution since the attacks</description>
    <arm_group_label>Subjects who contacted CUMP by phone</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who called the CUMP of Paris, London, Barcelone and Strasbourg after terrorist&#xD;
        attacks were either direct, undirect victims or their relatives.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All subjects who called the CUMP of Paris between November 13th, 2015 and January 31st,&#xD;
        2016; London 11th,2017 ; Barcelone 17-18th, 2017 ; Strasbourg 11th, 2018 and completed the&#xD;
        questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Subjects who did not consent to their participation to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gaëlle ABGRALL-BARBRY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gaëlle ABGRALL-BARBRY, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CUMP Paris</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Terrorist attack</keyword>
  <keyword>Post-Traumatic Stress Disorder</keyword>
  <keyword>Depression</keyword>
  <keyword>Psychotherapy</keyword>
  <keyword>Mental health</keyword>
  <keyword>Victimology</keyword>
  <keyword>Mourning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <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/NCT03770156
org study id: NI18012J
secondary id: 2017-A01382-51
nct id: NCT03770156
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
On November 13th 2015, a terrorist attack killed 129 victims in Paris. An emergency crisis
      unit (CUMP) has been activated in Paris in the days following the attack and a subunit was in
      charge to answer to the phone calls of victims and their relatives. The same emergency crisis
      unit have been activated for the terrorist attack in London, 2017 june 3, terrorist attack in
      Barcelone 2017 august 17-18, terrorist attack in Strasbourg 2018 December 11 The purpose of
      this observational study is to document the evolution of psychiatric symptoms among subjects
      who called the CUMP and to collect information about the type of medical or non-medical care
      they were seeking for.
The care of the victims of natural disasters or mass disasters such as terrorist attacks is
      now better structured and organized. The efficacy of debriefing or of defusing has been and
      is still debated, sometimes bitterly. The aim of the present study is not to demonstrate
      utility or futility of such approaches, but to i) evaluate their global improvement over the
      past three years. ii) to list the type of support that the victims were seeking in their
      attempt to get rid of the symptoms which appeared after the terrorist attack of November 2015
      in Paris.

      iii) to collect their opinions about the way the CUMP (emergency medico-psychological unit of
      Paris, France) managed the support to the victims.

      Participating subjects registered on the occasion of their first contact with the CUMP 75 by
      phone during the week following the attack
observational model: Cohort
time perspective: Prospective
measure: Clinical Global Impression - Improvement scale (CGI-I)
time frame: One day
description: Self-assessment of improvement or aggravation
measure: Clinical Global Impression - Severity scale (CGI-S)
time frame: One day
description: Self-assessment of symptom severity
arm group label: Subjects who contacted CUMP by phone
description: Subjects who contacted CUMP (Medical Psychological Emergency Cell) by phone from Paris November 13th, 2015, London 11th,2017 ; Barcelone 17-18th, 2017 ; Strasbourg 11th, 2018.
intervention type: Behavioral
intervention name: Questionnaires
description: Overall Impression of the current state and evolution since the attacks
arm group label: Subjects who contacted CUMP by phone
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gaëlle ABGRALL-BARBRY, MD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Gaëlle ABGRALL-BARBRY, MD
role: Study Chair
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No