- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479670
Psychometric and Patholinguistic Assessment of Psychotrauma Related to Natural Hazards in the Commune of "Le Prêcheur" (EP3LAN)
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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Fort-de-France, Martinique, 97261
- CHU of Martinique
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individual over 18,
- Residing on the town of Le Prêcheur,
- Having been informed of the study,
- And having made a non-opposition decision to participate in the study.
Exclusion Criteria:
- Individual under the protection of justice or under guardianship,
- Individual with cognitive impairment incompatible with the collection of information,
- Individual who has undergone head trauma for less than one year or with residual clinical symptoms of trauma regardless of seniority,
- Individual with a proven serious suicidal risk.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Word frequency calculation
Time Frame: 12 months
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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. |
12 months
|
|
Repository classification of words
Time Frame: 12 months
|
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. |
12 months
|
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Patholinguistic classification of words
Time Frame: 12 months
|
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. |
12 months
|
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Visualization of reference universes
Time Frame: 12 months
|
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. |
12 months
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Application of the patholinguistic scenario
Time Frame: 12 months
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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 |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assess the overall mental health status
Time Frame: 12 months
|
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. |
12 months
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Evaluate the symptomatology of psychotrauma patients
Time Frame: 12 months
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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. |
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Louis JEHEL, PhD, CHU de Martinique
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19_RIPH3-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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