Psychological TraumaEP3LANNCT04479670
Psychometric and Patholinguistic Assessment of Psychotrauma Related to Natural Hazards in the Commune of "Le Prêcheur"
An observational study of Psychological Trauma and Posttraumatic Stress Disorder PTSD, run by University Hospital Center of Martinique at 1 site in Martinique.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Trauma, Posttraumatic Stress Disorder PTSD, Mass Casualty Incidents
- How many people
- 59 participants
- Where
- 1 siteMartinique
- Study dates
- 26 Mar 2021to 7 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults subjects living in the commune of "Le Prêcheur" in Martinique
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Psychometrics, Patholinguistics, Psychotraumatism, Posttraumatic Stress Disorder PTSD, Natural hazard, Crisis management
- Medical subject headings
- Psychological Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start26 Mar 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche en Épidémiologie et Santé des Populations (CESP), Institut National de la Santé Et de la Recherche Médicale, France, SOS KRIZ
- Responsible party
- Sponsor
- Investigators
- Louis JEHEL, PhD, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479670
- Sponsor's protocol ID
- 19_RIPH3-20
- Acronym
- EP3LAN
- Status last verified
- Sep 2022
- First submitted
- 10 Jul 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric and Patholinguistic Assessment of Psychotrauma Related to Natural Hazards in the Commune of "Le Prêcheur"
- ClinicalTrials.gov ID
- NCT04479670
- Acronym / sponsor ID
- EP3LAN / 19_RIPH3-20
- Keywords
- Psychometrics, Patholinguistics, Psychotraumatism, Posttraumatic Stress Disorder PTSD, Natural hazard, Crisis management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Centre de recherche en Épidémiologie et Santé des Populations (CESP), Institut National de la Santé Et de la Recherche Médicale, France, SOS KRIZ
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults subjects living in the commune of "Le Prêcheur" in Martinique
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Word frequency calculation
Time frame: 12 months
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.
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.
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.
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.
Application of the patholinguistic scenario
Time frame: 12 months
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
2 secondary outcomes
Assess the overall mental health status
Time frame: 12 months
Evaluate the symptomatology of psychotrauma patients
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis JEHEL, PhD principal investigator
CHU de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Trauma and Posttraumatic Stress Disorder PTSD, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word frequency calculation (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.