<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/NCT04405362</url>
  </required_header>
  <id_info>
    <org_study_id>2020_39</org_study_id>
    <secondary_id>2020-A01186-33</secondary_id>
    <nct_id>NCT04405362</nct_id>
  </id_info>
  <brief_title>Consequences of the QUARANTINE Relating to the COvid-19 Epidemic on the Mental Health of the Patients Followed in PSYchiatry</brief_title>
  <acronym>QUARCOPSY</acronym>
  <official_title>Consequences of the QUARANTINE Relating to the COvid-19 Epidemic on the Mental Health of the Patients Followed in PSYchiatry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      Quarantine related to the Covid-19 pandemic has begun on the 03/17/2020 in France. Quarantine&#xD;
      has already be linked to pejorative effects on mental health. In this study, we aim to&#xD;
      evaluated PTSD symptoms of patients already followed by a psychiatrist during quarantine, one&#xD;
      month and 3 months after inclusion. It will be also evaluate various psychiatric symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 2020</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</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 post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine</measure>
    <time_frame>at inclusion</time_frame>
    <description>PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine</measure>
    <time_frame>at 1 month after inclusion</time_frame>
    <description>PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine</measure>
    <time_frame>at 3 months after inclusion</time_frame>
    <description>PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) (6). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IES-R (Impact of Events Scale Revised)</measure>
    <time_frame>at inclusion, then at 1 month and 3 months after inclusion</time_frame>
    <description>This self-questionnaire is intended to measure subjective post-traumatic stress after a traumatic situation (within 7 days) but is not a diagnostic tool. It includes 22 items rated from 0 (not at all) to 4 (extremely). There are 3 sub-scales:&#xD;
an avoidance subscale (items 5, 7, 8, 11, 12, 13, 17, 22): the sum of the scores on each of these items ranges from 0 to 35;&#xD;
Memory intrusion subscale (items 1, 2, 3, 6, 9, 14, 16 and 20): the sum of the scores on each of these items ranges from 0 to 40;&#xD;
a Hyperarousal/High Neurovegetative Activation subscale (items 4, 10, 15, 18, 19 and 21): the sum of the scores on each of these items ranges from 0 to 35.&#xD;
A total score of at least 22 suggests the presence of significant symptoms of acute stress. A score of 36 and above suggests the presence of post-traumatic stress disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of suicidal ideation during the past month at the different times of the study</measure>
    <time_frame>at inclusion, then at 1 month and 3 months after inclusion</time_frame>
    <description>closed-ended question: Yes /No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total score at GHQ-28 (General Health Questionnaire)</measure>
    <time_frame>at inclusion, then at 1 month and 3 months after inclusion</time_frame>
    <description>questionnaire with a 28 item scaled and assesses somatic symptoms, anxiety and insomnia, social dysfunction and severe depression that ranges from a 'better/healthier than normal' option, through a 'same as usual' and a 'worse/more than usual' to a 'much worse/more than usual' option. The exact wording will depend upon the particular nature of the item.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total score at BDI (Beck Depression Inventory)</measure>
    <time_frame>at inclusion, then at 1 month and 3 months after inclusion</time_frame>
    <description>13 questions rated from 0 to 3 to obtain a score from 0 to 39 The higher the score, the greater the symptomatology: 0 to 3 (no depression), 4 to 7 (mild depression), 8 to 15 (depression of moderate to moderate intensity), greater than 16 (severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total score at ISI (Insomnia Severity Index)</measure>
    <time_frame>at inclusion, then at 1 month and 3 months after inclusion</time_frame>
    <description>7 questions rated from 0 to 4 to obtain a score from 0 to 28 The higher the score, the greater the symptomatology: 0 to 7 (no insomnia), 8 to 14 (mild insomnia), 15 to 21 (moderate insomnia), 22 to 28 (severe insomnia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in alcohol and/or cannabis consumption during and at the end of the quarantine period</measure>
    <time_frame>at inclusion, then at 1 month and 3 months after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total score Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)</measure>
    <time_frame>at inclusion, then at 1 month and 3 months after inclusion</time_frame>
    <description>It's a Likert scale from 14 to 70. The higher the score, the higher the level of well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Socio-demographic factors significantly associated with all scores</measure>
    <time_frame>at inclusion, then at 1 month and 3 months after inclusion</time_frame>
    <description>Socio-demographic factors, linked to medical history and the experience of the epidemic.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">753</enrollment>
  <condition>SARS-CoV 2</condition>
  <condition>Traumatic Stress Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patient with psychotic disorder, mood disorders, labile emotional personality disorder,&#xD;
        anxiety disorders and somatoform disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients already followed in psychiatry before quarantine by one of the psychiatrists&#xD;
             subscribed to L'Encéphale online.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to complete the questionnaire&#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>Arnaud Leroy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arnaud Leroy, MD</last_name>
    <phone>03 20 44 44 60</phone>
    <email>arnaud.leroy@chru-lille.fr</email>
  </overall_contact>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>quarantine</keyword>
  <keyword>Psychiatric Traumatic Stress Disorder</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>
  </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/NCT04405362
org study id: 2020_39
secondary id: 2020-A01186-33
nct id: NCT04405362
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Quarantine related to the Covid-19 pandemic has begun on the 03/17/2020 in France. Quarantine
      has already be linked to pejorative effects on mental health. In this study, we aim to
      evaluated PTSD symptoms of patients already followed by a psychiatrist during quarantine, one
      month and 3 months after inclusion. It will be also evaluate various psychiatric symptoms.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine
time frame: at inclusion
description: PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.
measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine
time frame: at 1 month after inclusion
description: PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.
measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine
time frame: at 3 months after inclusion
description: PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) (6). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.
measure: IES-R (Impact of Events Scale Revised)
time frame: at inclusion, then at 1 month and 3 months after inclusion
description: This self-questionnaire is intended to measure subjective post-traumatic stress after a traumatic situation (within 7 days) but is not a diagnostic tool. It includes 22 items rated from 0 (not at all) to 4 (extremely). There are 3 sub-scales:
an avoidance subscale (items 5, 7, 8, 11, 12, 13, 17, 22): the sum of the scores on each of these items ranges from 0 to 35;
Memory intrusion subscale (items 1, 2, 3, 6, 9, 14, 16 and 20): the sum of the scores on each of these items ranges from 0 to 40;
a Hyperarousal/High Neurovegetative Activation subscale (items 4, 10, 15, 18, 19 and 21): the sum of the scores on each of these items ranges from 0 to 35.
A total score of at least 22 suggests the presence of significant symptoms of acute stress. A score of 36 and above suggests the presence of post-traumatic stress disorder.
measure: Presence of suicidal ideation during the past month at the different times of the study
time frame: at inclusion, then at 1 month and 3 months after inclusion
description: closed-ended question: Yes /No
measure: Total score at GHQ-28 (General Health Questionnaire)
time frame: at inclusion, then at 1 month and 3 months after inclusion
description: questionnaire with a 28 item scaled and assesses somatic symptoms, anxiety and insomnia, social dysfunction and severe depression that ranges from a 'better/healthier than normal' option, through a 'same as usual' and a 'worse/more than usual' to a 'much worse/more than usual' option. The exact wording will depend upon the particular nature of the item.
measure: Total score at BDI (Beck Depression Inventory)
time frame: at inclusion, then at 1 month and 3 months after inclusion
description: 13 questions rated from 0 to 3 to obtain a score from 0 to 39 The higher the score, the greater the symptomatology: 0 to 3 (no depression), 4 to 7 (mild depression), 8 to 15 (depression of moderate to moderate intensity), greater than 16 (severe depression).
measure: Total score at ISI (Insomnia Severity Index)
time frame: at inclusion, then at 1 month and 3 months after inclusion
description: 7 questions rated from 0 to 4 to obtain a score from 0 to 28 The higher the score, the greater the symptomatology: 0 to 7 (no insomnia), 8 to 14 (mild insomnia), 15 to 21 (moderate insomnia), 22 to 28 (severe insomnia).
measure: Changes in alcohol and/or cannabis consumption during and at the end of the quarantine period
time frame: at inclusion, then at 1 month and 3 months after inclusion
measure: Total score Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
time frame: at inclusion, then at 1 month and 3 months after inclusion
description: It's a Likert scale from 14 to 70. The higher the score, the higher the level of well-being.
measure: Socio-demographic factors significantly associated with all scores
time frame: at inclusion, then at 1 month and 3 months after inclusion
description: Socio-demographic factors, linked to medical history and the experience of the epidemic.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arnaud Leroy, MD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Arnaud Leroy, MD
phone: 03 20 44 44 60
email: arnaud.leroy@chru-lille.fr
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Stress Disorders, Traumatic