Suicide Risk 30 Days After a Potentially Traumatic Event in Patients Treated by a Medico-psychological Emergency Unit

Suicide Risk Clinical Trial

— SCAR  

Official title:

Suicide Risk Within 30 Days After a Potentially Traumatic Event (PTE) in Patients Treated by a Medico-psychological Emergency Unit. Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04898049
• Other study ID #: 38RC20.398
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: Caroline Sanchez, PhD
• Phone: +33476634256
• Email: csanchez5[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Estimate the prevalence of suicide risk 30 days after exposure to a potentially traumatic event, in people treated by a CUMP

The secondary objective aim to identify:

1. The main psychiatric disorders at 30 days (depressive disorders, bipolar disorders, panic disorder, agoraphobia, social phobia, generalized anxiety, post-traumatic stress disorder, obsessive-compulsive disorder, disorder linked to the consumption of alcohol or other substances, psychotic disorders, eating disorders)

2. The number of death by suicide 1 year after the trauma

3. The incidence of suicide attempts 1 year after the trauma

4. The incidence of suicidal ideation 1 year of trauma Prognostic factors of mortality by suicide, suicide attempts or suicidal ideation will be sought.

A number of 215 individuals would give a precision of ± 5% to a point estimate equal to 15% of the prevalence of suicide risk at 30 days. Assuming a 10% refusal rate to participate in the follow-up visit, this number should be increased to 240 patients.

This number of 215 patients would give 80% power to a logistic regression model of the binary primary endpoint (Y, risk of suicide at 30 days) on a binary independent variable (X) in the presence of a binary covariate (Z). to detect, with an alpha risk of 0.05, an odds ratio equal to 2.50. This number is calculated under the assumption of a baseline risk for the primary endpoint Y of 0.15, the independence of observations, a prevalence of the independent variable X of 50%, a prevalence the covariate Z of 50% and an odds ratio of the primary endpoint Y associated with the covariate Z of 1.50. This number is calculated for a two-tailed Wald test.

The investigators believe that their study could have a real impact on CUMP practices and suicide risk prevention. In fact, the CUMP represents an original device and the context of the emergency and support groups may overlook the risk of suicide for some patients. In addition, there is currently no systematic monitoring planned within the CUMPs. It is therefore an innovative and particularly topical subject that could change clinical practices but also the organization of the healthcare offer. Indeed, several treatment centers for psychotrauma are currently being deployed at the national level (including a center in Lyon, within the Hospices Civils de Lyon (HCL)) and an important work of coordination of treatment structures is in progress.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: April 30, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Emergencies
• Suicide
• Suicide Risk

Locations

Country	Name	City	State
France	DELACHENAL Catherine	Chambéry
France	Geneste-Saelens	Clermont-Ferrand
France	VIGNAUD Philippe	Lyon
France	COURVOISIER Pierre	Montéléger

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Depressive disorders	Absence or presence of depressive disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Bipolar disorders	Absence or presence of bipolar disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Panic disorder	Absence or presence of panic disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Agoraphobia	Absence or presence of agoraphobia used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Social phobia	Absence or presence of social phobia used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Generalized anxiety	Absence or presence of generalized anxiety used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Post-traumatic stress disorder	Absence or presence of post-traumatic stress disorder used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Obsessive-compulsive disorder	Absence or presence of obsessive-compulsive disorder used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Disorder linked to the consumption of alcohol or other substances	Absence or presence of disorder linked to the consumption of alcohol or other substances used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Psychotic disorders	Absence or presence of psychotic disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Eating disorders	Absence or presence of eating disorders used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma	30 days
Secondary	Mortality by suicide	Mortality by suicide after the psychological trauma (the cause of death is obtained from a trusted third party or from the attending physician)	365 days
Secondary	Incidence of suicide	Number of patients having presented at least one suicide attempt during the 365 days after the psychological trauma (declaration of the patient or, in his absence, of the declared trusted person or the general practitioner)	365 days
Secondary	Incidence of suicidal ideation	Number of patients declaring that they have presented suicidal ideation at least once during the 365 days after the psychological trauma (question yes / no)	365 days