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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04479670
Other study ID # 19_RIPH3-20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 26, 2021
Est. completion date June 7, 2022

Study information

Verified date September 2022
Source University Hospital Center of Martinique
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date June 7, 2022
Est. primary completion date June 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Martinique CHU of Martinique Fort-de-France

Sponsors (4)

Lead Sponsor Collaborator
University Hospital Center of Martinique Centre de recherche en Épidémiologie et Santé des Populations (CESP), Institut National de la Santé Et de la Recherche Médicale, France, SOS KRIZ

Country where clinical trial is conducted

Martinique, 

Outcome

Type Measure Description Time frame Safety issue
Primary Word frequency calculation 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
Primary Repository classification of words 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
Primary Patholinguistic classification of words 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
Primary Visualization of reference universes 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
Primary Application of the patholinguistic scenario 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 Assess the overall mental health status 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
Secondary Evaluate the symptomatology of psychotrauma patients 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
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