<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/NCT04479670</url>
  </required_header>
  <id_info>
    <org_study_id>19_RIPH3-20</org_study_id>
    <nct_id>NCT04479670</nct_id>
  </id_info>
  <brief_title>Psychometric and Patholinguistic Assessment of Psychotrauma Related to Natural Hazards in the Commune of &quot;Le Prêcheur&quot;</brief_title>
  <acronym>EP3LAN</acronym>
  <official_title>Psychometric and Patholinguistic Assessment of Psychotrauma Related to Natural Hazards in the Commune of &quot;Le Prêcheur&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre de recherche en Épidémiologie et Santé des Populations (CESP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SOS KRIZ</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Center of Martinique</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 project is to study the evolution of mental health in a little town of the French&#xD;
      Martinique (Le Prêcheur) by using an innovative method of analysis that combines&#xD;
      patholinguistic and psychometric indications for patients who risk of developing psychotrauma&#xD;
      due to a natural hazard. Investigators will gather precise and factual data concerning the&#xD;
      psychic and mental state of the population, by collecting patients' feelings and sentiments&#xD;
      through individual interviews and audio recordings that will be then transcribed, and&#xD;
      analyzed, and repeated, according to a quantitative, qualitative, and prospective&#xD;
      methodology.&#xD;
&#xD;
      This research is launched in order to meet the needs expressed both by the French authorities&#xD;
      and the population towards an optimization of crisis management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study focuses on the town of Le Prêcheur (1600 inhabitants) which has a geographical&#xD;
      location of dangerous threat at the foot of the Pelee volcano, generating intense stress and&#xD;
      psychotraumatic disorders. Indeed, faced with the phenomena of mudslides and boulders in&#xD;
      connection with volcanic activity (Lahars) and repeated alerts, several cases of Psychotrauma&#xD;
      have already been reported. Even if the municipal, territorial and state authorities have put&#xD;
      in place a large-scale action to keep the population safe, the process of moving the&#xD;
      neuralgic centers of the town will not be completed until 2021.&#xD;
&#xD;
      In the meantime, investigators propose to provide appropriate support for this situation via&#xD;
      the SOS Kriz platform and the Psychotraumatology center of Martinique University Hospital.&#xD;
&#xD;
      In order to reach this objective, the study team will conduct patholinguistic procedures to&#xD;
      the verbal recordings of persons from the town of Le Prêcheur every six months during one&#xD;
      year. This analysis is carried out semi-automatically using a cognitive-discursive analysis&#xD;
      software (Tropes1).&#xD;
&#xD;
      Two validated psychometric tests (GHQ-12 and PCL-5) to supplement the patholinguistic data&#xD;
      will be used.&#xD;
&#xD;
      This mixed trial aims to evaluate the evolution of the overall state of mental health of the&#xD;
      population via a patholinguistic and psychometric measurement device, to be able to target&#xD;
      the actions of care and support to victims of psychotrauma related to risks of natural&#xD;
      disaster in the commune of Prêcheur in Martinique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2021</start_date>
  <completion_date type="Actual">June 7, 2022</completion_date>
  <primary_completion_date type="Actual">June 7, 2022</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>Word frequency calculation</measure>
    <time_frame>12 months</time_frame>
    <description>The software calculates word frequency used in transcripts, drawing on their number of occurrences and grouping them by linguistic category (modalisation, verb, noun, adjective, pronoun, negation, etc.).&#xD;
Objective: define keywords according to their frequency.&#xD;
Expected Result: List of categories of words present in the speech with indication of a frequency percentage for each category as well as list of the most popular categories frequent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Repository classification of words</measure>
    <time_frame>12 months</time_frame>
    <description>The software groups the most frequent words in &quot;reference universes&quot;, relying on their proximity or distance by relation to a key word which represents a central concept (e.g. feeling, feeling, behavior, time, family, crisis, etc.).&#xD;
Objective: Group the most frequent words by semantic affinities.&#xD;
Expected result: List of keywords in each reference universe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patholinguistic classification of words</measure>
    <time_frame>12 months</time_frame>
    <description>The expert analyst intervenes to relate the key words of the discourse to definitive concepts of the targeted pathologies (ex. reviviscence, avoidance, negativity, reactivity, etc.).&#xD;
Objective: Constitute a predictive scenario concerning the pathology.&#xD;
Expected result: A reference table of patholinguistic concepts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visualization of reference universes</measure>
    <time_frame>12 months</time_frame>
    <description>The software presents the keywords under form of concentric circles representing the semantic fields, indicating both the weight of each word (by varying the size of the circle) and its proximity or distance compared to the other keywords (on the different rings).&#xD;
Objective: Obtain a cognitive and mental representation of the speech.&#xD;
Expected result: Image representing the center and the periphery of a reference universe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Application of the patholinguistic scenario</measure>
    <time_frame>12 months</time_frame>
    <description>The analyst applies to the general reference universe, statically defined by the software, its specific reading grid (the patholinguistic scenario).&#xD;
Objective: Obtain a patholinguistic representation of the speech.&#xD;
Expected result: Image representing the center and the periphery of a patholinguistic concept</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the overall mental health status</measure>
    <time_frame>12 months</time_frame>
    <description>The corresponding score for each subject will be used to answer the General Health Questionnaire in 12 items, for the overall measure of mental health.&#xD;
The minimum value is 0, the maximum value is 12. A score greater than or equal to 2 would correspond to a psychiatric disorder.&#xD;
The difference for each subject between the GHQ-12 score at inclusion and patholinguistic quantitative variables collected at inclusion M0 and repeated at M6 and M12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the symptomatology of psychotrauma patients</measure>
    <time_frame>12 months</time_frame>
    <description>The Posttraumatic Stress Disorder CheckList Scale in 20 items will be used for screening and monitoring PTSD.&#xD;
The minimum value is 0, the maximum value is 80. A threshold value of 38 suggests the presence of PTSD.&#xD;
The difference for each subject between the PCL-5 score at inclusion and patholinguistic quantitative variables collected at inclusion M0 and repeated at M6 and M12.</description>
  </secondary_outcome>
  <enrollment type="Actual">59</enrollment>
  <condition>Psychological Trauma</condition>
  <condition>Posttraumatic Stress Disorder PTSD</condition>
  <condition>Mass Casualty Incidents</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults subjects living in the commune of &quot;Le Prêcheur&quot; in Martinique&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individual over 18,&#xD;
&#xD;
          -  Residing on the town of Le Prêcheur,&#xD;
&#xD;
          -  Having been informed of the study,&#xD;
&#xD;
          -  And having made a non-opposition decision to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individual under the protection of justice or under guardianship,&#xD;
&#xD;
          -  Individual with cognitive impairment incompatible with the collection of information,&#xD;
&#xD;
          -  Individual who has undergone head trauma for less than one year or with residual&#xD;
             clinical symptoms of trauma regardless of seniority,&#xD;
&#xD;
          -  Individual with a proven serious suicidal risk.&#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>Louis JEHEL, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Martinique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU of Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Martinique</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 12, 2022</last_update_submitted>
  <last_update_submitted_qc>September 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psychometrics</keyword>
  <keyword>Patholinguistics</keyword>
  <keyword>Psychotraumatism</keyword>
  <keyword>Posttraumatic Stress Disorder PTSD</keyword>
  <keyword>Natural hazard</keyword>
  <keyword>Crisis management</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>
    <mesh_term>Psychological Trauma</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/NCT04479670
org study id: 19_RIPH3-20
nct id: NCT04479670
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The project is to study the evolution of mental health in a little town of the French
      Martinique (Le Prêcheur) by using an innovative method of analysis that combines
      patholinguistic and psychometric indications for patients who risk of developing psychotrauma
      due to a natural hazard. Investigators will gather precise and factual data concerning the
      psychic and mental state of the population, by collecting patients' feelings and sentiments
      through individual interviews and audio recordings that will be then transcribed, and
      analyzed, and repeated, according to a quantitative, qualitative, and prospective
      methodology.

      This research is launched in order to meet the needs expressed both by the French authorities
      and the population towards an optimization of crisis management.
The study focuses on the town of Le Prêcheur (1600 inhabitants) which has a geographical
      location of dangerous threat at the foot of the Pelee volcano, generating intense stress and
      psychotraumatic disorders. Indeed, faced with the phenomena of mudslides and boulders in
      connection with volcanic activity (Lahars) and repeated alerts, several cases of Psychotrauma
      have already been reported. Even if the municipal, territorial and state authorities have put
      in place a large-scale action to keep the population safe, the process of moving the
      neuralgic centers of the town will not be completed until 2021.

      In the meantime, investigators propose to provide appropriate support for this situation via
      the SOS Kriz platform and the Psychotraumatology center of Martinique University Hospital.

      In order to reach this objective, the study team will conduct patholinguistic procedures to
      the verbal recordings of persons from the town of Le Prêcheur every six months during one
      year. This analysis is carried out semi-automatically using a cognitive-discursive analysis
      software (Tropes1).

      Two validated psychometric tests (GHQ-12 and PCL-5) to supplement the patholinguistic data
      will be used.

      This mixed trial aims to evaluate the evolution of the overall state of mental health of the
      population via a patholinguistic and psychometric measurement device, to be able to target
      the actions of care and support to victims of psychotrauma related to risks of natural
      disaster in the commune of Prêcheur in Martinique.
observational model: Cohort
time perspective: Prospective
measure: Word frequency calculation
time frame: 12 months
description: The software calculates word frequency used in transcripts, drawing on their number of occurrences and grouping them by linguistic category (modalisation, verb, noun, adjective, pronoun, negation, etc.).
Objective: define keywords according to their frequency.
Expected Result: List of categories of words present in the speech with indication of a frequency percentage for each category as well as list of the most popular categories frequent.
measure: Repository classification of words
time frame: 12 months
description: The software groups the most frequent words in "reference universes", relying on their proximity or distance by relation to a key word which represents a central concept (e.g. feeling, feeling, behavior, time, family, crisis, etc.).
Objective: Group the most frequent words by semantic affinities.
Expected result: List of keywords in each reference universe.
measure: Patholinguistic classification of words
time frame: 12 months
description: The expert analyst intervenes to relate the key words of the discourse to definitive concepts of the targeted pathologies (ex. reviviscence, avoidance, negativity, reactivity, etc.).
Objective: Constitute a predictive scenario concerning the pathology.
Expected result: A reference table of patholinguistic concepts.
measure: Visualization of reference universes
time frame: 12 months
description: The software presents the keywords under form of concentric circles representing the semantic fields, indicating both the weight of each word (by varying the size of the circle) and its proximity or distance compared to the other keywords (on the different rings).
Objective: Obtain a cognitive and mental representation of the speech.
Expected result: Image representing the center and the periphery of a reference universe.
measure: Application of the patholinguistic scenario
time frame: 12 months
description: The analyst applies to the general reference universe, statically defined by the software, its specific reading grid (the patholinguistic scenario).
Objective: Obtain a patholinguistic representation of the speech.
Expected result: Image representing the center and the periphery of a patholinguistic concept
measure: Assess the overall mental health status
time frame: 12 months
description: The corresponding score for each subject will be used to answer the General Health Questionnaire in 12 items, for the overall measure of mental health.
The minimum value is 0, the maximum value is 12. A score greater than or equal to 2 would correspond to a psychiatric disorder.
The difference for each subject between the GHQ-12 score at inclusion and patholinguistic quantitative variables collected at inclusion M0 and repeated at M6 and M12.
measure: Evaluate the symptomatology of psychotrauma patients
time frame: 12 months
description: The Posttraumatic Stress Disorder CheckList Scale in 20 items will be used for screening and monitoring PTSD.
The minimum value is 0, the maximum value is 80. A threshold value of 38 suggests the presence of PTSD.
The difference for each subject between the PCL-5 score at inclusion and patholinguistic quantitative variables collected at inclusion M0 and repeated at M6 and M12.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Louis JEHEL, PhD
role: Principal Investigator
affiliation: CHU de Martinique
facility: 
country: Martinique
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Psychological Trauma