Psychological Trauma Clinical Trial
— EP3LANOfficial title:
Psychometric and Patholinguistic Assessment of Psychotrauma Related to Natural Hazards in the Commune of "Le Prêcheur"
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 |
Verified date | September 2022 |
Source | University Hospital Center of Martinique |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Martinique | CHU of Martinique | Fort-de-France |
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 |
Martinique,
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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