Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898049
Status:
UNKNOWN
Last Update Posted:
2022-05-27
First Post:
2021-05-18
Brief Title:
Suicide Risk 30 Days After a Potentially Traumatic Event in Patients Treated by a Medico-psychological Emergency Unit
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCAR
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 302 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 199 95 CI 173-228 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
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
Detailed 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 302 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 199 95 CI 173-228 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 005 an odds ratio equal to 250 This number is calculated under the assumption of a baseline risk for the primary endpoint Y of 015 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 150 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
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 005 an odds ratio equal to 250 This number is calculated under the assumption of a baseline risk for the primary endpoint Y of 015 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 150 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None