NCT04898049

Brief Summary

The national french survey "Mental health in general population", showed that the risk of suicide was significantly increased during exposure to a potentially traumatic event (PTE), with an increasing gradient depending on the psychological impact. This included not only people suffering from post-traumatic stress disorder but also those confronted with PTE, presenting or having presented phenomena of reviviscence or at least an element of psychopathological impact. This risk could concern 30.2% of the population over the entire lifetime. Internationally, recent reviews of the literature tend to show that victims of interpersonal violence are more at risk of suicide (OR 1.99 95% CI: 1.73-2.28). Nevertheless, the literature remains heterogeneous, the definitions vague and the temporal proximity of the violence little taken into account. It is therefore a large-scale phenomenon that remains little explored. To increase our knowledge in this area, the investigators will focus on patients treated by Emergency Medical Psychological Cells (CUMP), that is victims of disasters, accidents involving a large number of victims or events that may have significant psychological repercussions due to the circumstances surrounding them.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

May 18, 2021

Last Update Submit

May 23, 2022

Conditions

Keywords

Suicide riskpotentially traumatic eventmedico-psychological emergency unit30 days

Outcome Measures

Primary Outcomes (1)

  • Suicidal risk

    Absence or presence of the suicidal risk assessed using the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma

    30 days

Secondary Outcomes (14)

  • Depressive disorders

    30 days

  • Bipolar disorders

    30 days

  • Panic disorder

    30 days

  • Agoraphobia

    30 days

  • Social phobia

    30 days

  • +9 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients fulfilling the inclusion and non-inclusion criteria and having signed the consent will be included. Within 30 days (± 5 days), an appointment, by videoconference, will be made by the CUMP of the Grenoble center for the completion of the MINI scale and screening for suicidal behavior. This interview will be carried out either with the psychiatrist or the psychologist or with the psychiatric resident. If the patient does not answer, the trusted third party or the attending physician will be contacted by telephone in order to investigate the causes or to detect a possible death by suicide. The patient will be followed up one year after inclusion by telephone to detect the number of suicide attempts and/or death.

You may qualify if:

  • Patient treated for the first time by a CUMP directly confronted with a potentially traumatic event (PTE) (with ou without a previous psychiatric history)
  • Patient affiliated with social welfare

You may not qualify if:

  • Age under 18
  • Not understanding French language.
  • Not having provided the contact details of a trusted third party and of the attending physician
  • Being homeless
  • Information on the exhibition unavailable (subjects recently arrived in France, foreign language, etc.)
  • A pathology requiring urgent medical treatment
  • Covered by articles L1121-5 to L1121-8 of the CSP (pregnant women, parturients, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care and adults subject to a measure of legal protection or unable to express their consent).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

DELACHENAL Catherine

Chambéry, France

Location

Geneste-Saelens

Clermont-Ferrand, France

Location

VIGNAUD Philippe

Lyon, France

Location

COURVOISIER Pierre

Montéléger, France

Location

Study Officials

  • Helene Poncet, MD

    CHU Grenoble Alpes, SAMU38 - CUMP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Sanchez, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 24, 2021

Study Start

September 1, 2022

Primary Completion

August 30, 2023

Study Completion

April 30, 2024

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations