<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/NCT04491071</url>
  </required_header>
  <id_info>
    <org_study_id>20CH129</org_study_id>
    <secondary_id>IRBN972020/CHUSTE</secondary_id>
    <nct_id>NCT04491071</nct_id>
  </id_info>
  <brief_title>Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.</brief_title>
  <acronym>SCEI</acronym>
  <official_title>Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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 aim of this project is to evaluate the impact of pandemic and nonconfinement related to&#xD;
      anxiety and eventual immune diseases with several standardized questionnaires : Implant&#xD;
      Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health&#xD;
      Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close&#xD;
      Relationship Scale (ECRS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The COVID-19 pandemic and prevention strategise have strongly impacted family lives, social&#xD;
      lives, professional lives, and income; resulting in increased reporting of stress and anxiety&#xD;
      within patients. This risk of infection 'post-confinement' is an additional source of stress&#xD;
      for people returning to their professional and social lives. There are evidence showing a&#xD;
      relationship between stress, immunity and the prognosis of several infections and&#xD;
      inflammatory diseases.&#xD;
&#xD;
      The COVID-19 pandemic and prevention strategise have strongly impacted family lives and&#xD;
      induced a high level of anxiety and other types of stress. This risk of infection&#xD;
      'post-confinement' is an additional source of stress for people returning to their&#xD;
      professional and social life.&#xD;
&#xD;
      There are evidences showing a relationship between stress, immunity and the prognosis of&#xD;
      several infections and inflammatory diseases.&#xD;
&#xD;
      The aim of this project is to launch an online survey that measures population stress felt&#xD;
      during the pandemic and post-confinement time and possible effects on eventual immune&#xD;
      mediated disorders (allergies, auto-immunity..) through the report of new events or flares.&#xD;
      The stress will first be measured on standardized anxiety GAD-7scale but also on more&#xD;
      parameters (ISQ, PHQ-9, PTSD-8, and ECR-S). Socio-economic and environmental parameters will&#xD;
      be recorded.&#xD;
&#xD;
      Level of anxiety and other stress parameters as well as occurrence of inflammatory events&#xD;
      will be measured according to the calendar and confinement /post confinement timing. Risk&#xD;
      factors will be looked for, by multi parametric data analysis.&#xD;
&#xD;
      The survey has been built in a user-friendly, accessible way so the investigators can expect&#xD;
      a high number of participants (at least 400), especially as people are highly concerned by&#xD;
      the situation and will be motivated to take part.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was stopped due to lack of inclusions&#xD;
  </why_stopped>
  <start_date type="Actual">October 22, 2020</start_date>
  <completion_date type="Actual">September 29, 2021</completion_date>
  <primary_completion_date type="Actual">September 29, 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>Results of the Generalized Anxiety Disorder (GAD-7)</measure>
    <time_frame>5 Minutes</time_frame>
    <description>test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry.&#xD;
Scored between 0-21:&#xD;
Cut offs:&#xD;
0-4 = None&#xD;
5-9 = Mild anxiety&#xD;
10-14 = Moderate anxiety&#xD;
15-21 = Severe anxiety</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Results of the Mental Health questionnaire</measure>
    <time_frame>5 minutes</time_frame>
    <description>Welfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Results of the Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>5 minutes</time_frame>
    <description>assess depression during the pandemic&#xD;
Scored between 0-27:&#xD;
Cut offs:&#xD;
0-4 = None&#xD;
5-9 = Mild depression&#xD;
10-14 = Moderate depression&#xD;
15-19 = Moderately severe depression&#xD;
20-27 = Severe depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Results of the Post Traumatic Stress Disorder (PTSD-8)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Assessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Measuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Volunteers</arm_group_label>
    <description>volunteers over 18 years of age</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Generalized Anxiety Disorder-7 (GAD 7)</intervention_name>
    <description>test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry.</description>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Background questionnaire</intervention_name>
    <description>questionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants</description>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Impact of COVID-19 questionnaire</intervention_name>
    <description>status of the patient with regard to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus)</description>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Confinement and Communication During the COVID-19 Pandemic</intervention_name>
    <description>know the experience of containment and isolation during the pandemic</description>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Mental Health questionnaire</intervention_name>
    <description>welfare effect</description>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Patient Health Questionnaire (PHQ-9)</intervention_name>
    <description>assess depression during the pandemic</description>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Post Traumatic Stress Disorder questionnaire (PTSD-8)</intervention_name>
    <description>Assessing the trauma of subjects during the pandemic</description>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Experiences in Close Relationship Scale questionnaire (ECR-S)</intervention_name>
    <description>Measuring social ties and attachment of subjects</description>
    <arm_group_label>Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Health Volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult volunteer who agreed to answer the questionnaires&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Adult affiliated or having a duty to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children under 18 years old&#xD;
&#xD;
          -  Inability to understand information letter, consent, or to use online questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claude LAMBERT, MD PhD HDR</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Saint-Etienne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche et d'Innovation Clinique</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Stress</keyword>
  <keyword>Effects on Immunity</keyword>
  <keyword>Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04491071
org study id: 20CH129
secondary id: IRBN972020/CHUSTE
nct id: NCT04491071
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this project is to evaluate the impact of pandemic and nonconfinement related to
      anxiety and eventual immune diseases with several standardized questionnaires : Implant
      Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health
      Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close
      Relationship Scale (ECRS).
The COVID-19 pandemic and prevention strategise have strongly impacted family lives, social
      lives, professional lives, and income; resulting in increased reporting of stress and anxiety
      within patients. This risk of infection 'post-confinement' is an additional source of stress
      for people returning to their professional and social lives. There are evidence showing a
      relationship between stress, immunity and the prognosis of several infections and
      inflammatory diseases.

      The COVID-19 pandemic and prevention strategise have strongly impacted family lives and
      induced a high level of anxiety and other types of stress. This risk of infection
      'post-confinement' is an additional source of stress for people returning to their
      professional and social life.

      There are evidences showing a relationship between stress, immunity and the prognosis of
      several infections and inflammatory diseases.

      The aim of this project is to launch an online survey that measures population stress felt
      during the pandemic and post-confinement time and possible effects on eventual immune
      mediated disorders (allergies, auto-immunity..) through the report of new events or flares.
      The stress will first be measured on standardized anxiety GAD-7scale but also on more
      parameters (ISQ, PHQ-9, PTSD-8, and ECR-S). Socio-economic and environmental parameters will
      be recorded.

      Level of anxiety and other stress parameters as well as occurrence of inflammatory events
      will be measured according to the calendar and confinement /post confinement timing. Risk
      factors will be looked for, by multi parametric data analysis.

      The survey has been built in a user-friendly, accessible way so the investigators can expect
      a high number of participants (at least 400), especially as people are highly concerned by
      the situation and will be motivated to take part.
observational model: Cohort
time perspective: Prospective
measure: Results of the Generalized Anxiety Disorder (GAD-7)
time frame: 5 Minutes
description: test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry.
Scored between 0-21:
Cut offs:
0-4 = None
5-9 = Mild anxiety
10-14 = Moderate anxiety
15-21 = Severe anxiety
measure: Results of the Mental Health questionnaire
time frame: 5 minutes
description: Welfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables.
measure: Results of the Patient Health Questionnaire (PHQ-9)
time frame: 5 minutes
description: assess depression during the pandemic
Scored between 0-27:
Cut offs:
0-4 = None
5-9 = Mild depression
10-14 = Moderate depression
15-19 = Moderately severe depression
20-27 = Severe depression
measure: Results of the Post Traumatic Stress Disorder (PTSD-8)
time frame: 5 minutes
description: Assessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables.
measure: Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)
time frame: 5 minutes
description: Measuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables.
arm group label: Volunteers
description: volunteers over 18 years of age
intervention type: Diagnostic Test
intervention name: Generalized Anxiety Disorder-7 (GAD 7)
description: test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry.
arm group label: Volunteers
intervention type: Diagnostic Test
intervention name: Background questionnaire
description: questionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants
arm group label: Volunteers
intervention type: Diagnostic Test
intervention name: Impact of COVID-19 questionnaire
description: status of the patient with regard to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus)
arm group label: Volunteers
intervention type: Diagnostic Test
intervention name: Confinement and Communication During the COVID-19 Pandemic
description: know the experience of containment and isolation during the pandemic
arm group label: Volunteers
intervention type: Diagnostic Test
intervention name: Mental Health questionnaire
description: welfare effect
arm group label: Volunteers
intervention type: Diagnostic Test
intervention name: Patient Health Questionnaire (PHQ-9)
description: assess depression during the pandemic
arm group label: Volunteers
intervention type: Diagnostic Test
intervention name: Post Traumatic Stress Disorder questionnaire (PTSD-8)
description: Assessing the trauma of subjects during the pandemic
arm group label: Volunteers
intervention type: Diagnostic Test
intervention name: Experiences in Close Relationship Scale questionnaire (ECR-S)
description: Measuring social ties and attachment of subjects
arm group label: Volunteers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Claude LAMBERT, MD PhD HDR
role: Principal Investigator
affiliation: CHU Saint-Etienne
facility: 
facility: 
country: France
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No