Suicide RiskSCARNCT04898049
Suicide Risk 30 Days After a Potentially Traumatic Event in Patients Treated by a Medico-psychological Emergency Unit
An observational study of Suicide Risk, run by University Hospital, Grenoble at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Risk
- How many people
- 240 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Sep 2022to 30 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
France4 sites
DELACHENAL Catherine
Chambéry
Catherine DELACHENAL, MD
Geneste-Saelens
Clermont-Ferrand
Julie GENESTE-SAELENS, MD
VIGNAUD Philippe
Lyon
Philippe VIGNAUD, MD
COURVOISIER Pierre
Montéléger
Pierre COURVOISIER, MD
About this study
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
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.
Read the 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 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:
- 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)
- The number of death by suicide 1 year after the trauma
- The incidence of suicide attempts 1 year after the trauma
- 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.
- Conditions
- Suicide Risk
- Keywords
- Suicide risk, potentially traumatic event, medico-psychological emergency unit, 30 days
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (14)
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
Agoraphobia
Absence or presence of agoraphobia used the French transcultural adaptation of the Mini-International Neuropsychiatric Interview (MINI) after the possible psychological trauma
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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
Measured: 30 days
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)
Measured: 365 days
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)
Measured: 365 days
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)
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Sep 2022 (estimated)
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide RiskStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Poncet, MD, Principal investigator, CHU Grenoble Alpes, SAMU38 - CUMP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898049
- Sponsor's protocol ID
- 38RC20.398
- Acronym
- SCAR
- Status last verified
- May 2022
- First submitted
- 18 May 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04898049
- Acronym / sponsor ID
- SCAR / 38RC20.398
- Conditions
- Suicide Risk
- Keywords
- Suicide risk, potentially traumatic event, medico-psychological emergency unit, 30 days
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 24 May 2021 (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 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.
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 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:
- 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)
- The number of death by suicide 1 year after the trauma
- The incidence of suicide attempts 1 year after the trauma
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
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
Suicidal risk
Time frame: 30 days
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
14 secondary outcomes
Depressive disorders
Time frame: 30 days
Bipolar disorders
Time frame: 30 days
Panic disorder
Time frame: 30 days
Agoraphobia
Time frame: 30 days
Social phobia
Time frame: 30 days
Generalized anxiety
Time frame: 30 days
Post-traumatic stress disorder
Time frame: 30 days
Obsessive-compulsive disorder
Time frame: 30 days
Disorder linked to the consumption of alcohol or other substances
Time frame: 30 days
Psychotic disorders
Time frame: 30 days
Eating disorders
Time frame: 30 days
Mortality by suicide
Time frame: 365 days
Incidence of suicide
Time frame: 365 days
Incidence of suicidal ideation
Time frame: 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 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.
Helene Poncet, MD principal investigator
CHU Grenoble Alpes, SAMU38 - CUMP
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide Risk, run by University Hospital, Grenoble at 4 sites in France.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Sanchez, PhD (+33476634256, csanchez5@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal risk (time frame: 30 days). 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 27 May 2022.