Suicidal IdeationsPLUSNCT06499337
Safety Plan in Emergency Department to Prevent Suicidal Attempt Recidive
An observational study of Suicidal Ideations and Suicidal Attempt, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
Suicide is one of the leading causes of death worldwide, with more than 700 000 deaths due to suicide every year, according to the World Health Organisation (WHO). In France, mortality rate by suicide is 17% higher than the European average; moreover, around 7% if the population (aged 18-75 years old) attempted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideations, Suicidal Attempt, Prevention
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 31 Jul 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: All individuals included in the study were patients hospitalized at the post-emergency short-term psychiatric unit following a visit to the emergency room for a suicide attempt. The recruitment took place between June 2022 and December 2023. Patients eligible for inclusion had to be adults, admitted to the hospital following a suicide attempt, and willing to participate in the study. The criteria for non-inclusion were: a) patients who were minors, b) patients who were unable to be informed or to understand the course of the study (if they did not understand French or if their condition did not allow it), c) patients who were opposed to the collection of data for research purposes, d) patients whose psychiatric and/or somatic condition was incompatible with the brief intervention and/or the study questionnaire
Who may be able to join
- Patients over 18 years old
- Patients hospitalised in a post-emergency unit following a suicidal attempt
Who cannot join
- Patients whose clinical state or French level prevent to understand the information regarding the study and to consent to the study
- Pattients whose clinical state or French level prevent to participate to the Safety plan intervention
- patients who do not agree to participate
Trial locations and contacts
1 site in 1 country.
France1 site
GHU Paris Psychiatrie et Neurosciences
Paris, Île-de-France Region, 75014
About this study
Official title: Evaluation of the Feasabilty and Acceptability of a Safety Plan After Suicidal Attempt to Prevent Recurrence After an Emergency Department Admission.
Suicide is one of the leading causes of death worldwide, with more than 700 000 deaths due to suicide every year, according to the World Health Organisation (WHO). In France, mortality rate by suicide is 17% higher than the European average; moreover, around 7% if the population (aged 18-75 years old) attempted suicide in their life.
Since years 2000, a series of preventative interventions have been developed to reduce suicide risk, with perhaps the most widely used is suicide safety planning. Several studies showed positive results after evaluating the efficacy of suicide safety planning for reducing patient risk. However, this intervention hasn't been yet evaluated in French emergency department settings.
Read more
Safety planning is a collaborative intervention between a therapist and the patient, by which a series of preventive actions are planned in the event patient experiences suicide ideation. Patients are provided with a paper form of the completed safety plan, including the following: personal warning signs, self-management strategies, reasons for living, social supports, and crisis supports.
In this study, we aim to assess the feasability and the acceptabilty of using the safety plan among patients hospitalised in a short-term unit, after an emergency department admission for suicidal attempt.
Read the detailed description
Suicide is one of the leading causes of death worldwide, with more than 700 000 deaths due to suicide every year, according to the World Health Organisation (WHO). In France, mortality rate by suicide is 17% higher than the European average; moreover, around 7% if the population (aged 18-75 years old) attempted suicide in their life.
Since years 2000, a series of preventative interventions have been developed to reduce suicide risk, with perhaps the most widely used is suicide safety planning, which is a brief intervention to help individuals who survived a suicide attempt to develop a set of tools and steps, to reduce the likelihood of engaging in suicidal behaviour. Several studies showed positive results after evaluating the efficacy of suicide safety planning for reducing patient risk. Recently, a systematic review concluded that Safety Planning is a valuable intervention for patients experiencing suicide-related distress, and was associated with improvements in suicidal ideation and behaviour and reductions in hospitalizations. Qualitative studies suggest a Safety Planning intervention is acceptable and feasible, as well as adaptable to the clinical area in its modality and delivery. Despite positive outcomes, this intervention has not been fully evaluated in French settings. A previous study concluded it was not adapted to emergency department due to a lack of time or available exam rooms for professionals to conduct the intervention. Therefore, in our study, participants will be recruited in a post-ED unit, where patients are monitored for maximum 72 hours, before being discharged home or transferred to hospital facilities.
Safety planning is a collaborative intervention between a healthcare worker and the patient, by which a series of preventive actions are planned in the event patient experiences suicide ideation. Safety planning included identifying: 1) warning signs or triggers that indicate suicide ideation is likely to occur, 2) internal coping strategies (e.g., distracting activities) for use when those triggers occur or when experiencing suicide ideation, 3) social contacts for further distraction or social locations that may provide distraction, 4) supportive contacts (who can provide assistance), 5) emergency resources (e.g., therapist phone numbers, hotlines, local hospital emergency room locations), and also included steps to ensure the safety of the home environment that minimize the patient's ability to act on suicidal thoughts or urges (i.e., reducing access to lethal means).
In this study, Safety plan was delivered face-to-face, during the post-ED stay; upon discharge, participants were provided with the paper-based plan they completed with their physician.
The main outcome of our study was to evaluate the feasibility - assessed by healthcare workers- and the acceptability - from patients' point of view- of conducting a Safety plan in a post-ED setting, after suicidal attempt. Secondary outcomes included to evaluate Safety plan utility, assessed by patients based on their use or not of the Safety plan at 1 and 6 months after inclusion, and its efficacy, on the recurrence of suicidal attempt over the 6 months after inclusion.
To evaluate the outcomes at 1 and 6 months, patients were recontacted by a psychologist to complete a brief questionnaire over the phone.
At baseline, we also collected sociodemographics information, including marital status and living situation; patients completed the Hospital anxiety and depression scale, and suicidal ideations evaluated with the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Conditions
- Suicidal Ideations, Suicidal Attempt, Prevention, Safety Plan
- Keywords
- Safety plan, Suicidal attempt, feasability, acceptability
- Medical subject headings
- Suicidal Ideation
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
The feasibility of implementing the safety plan was assessed with a questionnaire submitted to the caregivers who delivered the intervention. This self-administered questionnaire assessed: the time required to complete the safety plan, the availability of a suitable location for conducting the interview, the clinical and mood status of the individuals, and the difficulties encountered during the intervention. This questionnaire determined the feasibility score ranging from -4 to 6.
Measured: Day of intervention (D0)
Acceptability
A questionnaire for patients who had benefited from the safety plan was used to establish an overall acceptability score intervention. This questionnaire, partly based on Stanley's evaluation, allowed to determine an acceptability score, ranging from -8 to 8, a high positive value indicating a higher acceptance of the intervention by the patient. The acceptability score was calculated by summing the responses to the following questions: a) Have you ever had the opportunity to participate in an interview of this type (security plan)? b) Were the questions clear? c) Were there any questions that made you uncomfortable? d) Did you find this interview lengthy? e) Did you find the questions repetitive? f) Do you think you learned anything about yourself from this interview? g) Do you think the security plan can help you in your situation? h) Do you think this document could be useful to you in the future?
Measured: Day of intervention (D0)
Secondary outcomes (2)
Utility
Utility of the Saftey plan was assessed at 1 month, by asking participants if they retain their physical safety plan, they had use it since being discharged, and whether they find it useful.
Measured: 1 month after discharge
Efficacy
Efficacy was evaluated based on suicidal attempt recurrence over the 6 months following the intervention. Patients (or their emergency contact) were contacted by a mental healthcare worker to assess any new attempt.
Measured: Any suicidal attempt occuring up to 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jun 2022
- Primary completion23 Dec 2023
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499337
- Sponsor's protocol ID
- D21_PEPI-0011
- Acronym
- PLUS
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Ganay M, Duroy D, Perozziello A, Lejoyeux M, Geoffroy PA. Study assessing the feasibility and acceptability of implementing the Safety Plan for suicide prevention in a French emergency department. Encephale. 2023 Dec;49(6):656-657. doi: 10.1016/j.encep.2023.03.002. Epub 2023 Apr 28. No abstract available.
PubMed 37121806
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasabilty and Acceptability of a Safety Plan After Suicidal Attempt to Prevent Recurrence After an Emergency Department Admission.
- ClinicalTrials.gov ID
- NCT06499337
- Acronym / sponsor ID
- PLUS / D21_PEPI-0011
- Conditions
- Suicidal Ideations, Suicidal Attempt, Prevention, Safety Plan
- Keywords
- Safety plan, Suicidal attempt, feasability, acceptability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 12 Jul 2024 (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.
Suicide is one of the leading causes of death worldwide, with more than 700 000 deaths due to suicide every year, according to the World Health Organisation (WHO). In France, mortality rate by suicide is 17% higher than the European average; moreover, around 7% if the population (aged 18-75 years old) attempted suicide in their life.
Since years 2000, a series of preventative interventions have been developed to reduce suicide risk, with perhaps the most widely used is suicide safety planning. Several studies showed positive results after evaluating the efficacy of suicide safety planning for reducing patient risk. However, this intervention hasn't been yet evaluated in French emergency department settings.
Safety planning is a collaborative intervention between a therapist and the patient, by which a series of preventive actions are planned in the event patient experiences suicide ideation. Patients are provided with a paper form of the completed safety plan, including the following: personal warning signs, self-management strategies, reasons for living, social supports, and crisis supports.
In this study, we aim to assess the feasability and the acceptabilty of using the safety plan among patients hospitalised in a short-term unit, after an emergency department admission for suicidal attempt.
Detailed description
Suicide is one of the leading causes of death worldwide, with more than 700 000 deaths due to suicide every year, according to the World Health Organisation (WHO). In France, mortality rate by suicide is 17% higher than the European average; moreover, around 7% if the population (aged 18-75 years old) attempted suicide in their life.
Since years 2000, a series of preventative interventions have been developed to reduce suicide risk, with perhaps the most widely used is suicide safety planning, which is a brief intervention to help individuals who survived a suicide attempt to develop a set of tools and steps, to reduce the likelihood of engaging in suicidal behaviour. Several studies showed positive results after evaluating the efficacy of suicide safety planning for reducing patient risk. Recently, a systematic review concluded that Safety Planning is a valuable intervention for patients experiencing suicide-related distress, and was associated with improvements in suicidal ideation and behaviour and reductions in hospitalizations. Qualitative studies suggest a Safety Planning intervention is acceptable and feasible, as well as adaptable to the clinical area in its modality and delivery. Despite positive outcomes, this intervention has not been fully evaluated in French settings. A previous study concluded it was not adapted to emergency department due to a lack of time or available exam rooms for professionals to conduct the intervention. Therefore, in our study, participants will be recruited in a post-ED unit, where patients are monitored for maximum 72 hours, before being discharged home or transferred to hospital facilities.
Safety planning is a collaborative intervention between a healthcare worker and the patient, by which a series of preventive actions are planned in the event patient experiences suicide ideation. Safety planning included identifying: 1) warning signs or triggers that indicate suicide ideation is likely to occur, 2) internal coping strategies (e.g., distracting activities) for use when those triggers occur or when experiencing suicide ideation, 3) social contacts for further distraction or social locations that may provide distraction, 4) supportive contacts (who can provide assistance), 5) emergency resources (e.g., therapist phone numbers, hotlines, local hospital emergency room locations), and also included steps to ensure the safety of the home environment that minimize the patient's ability to act on suicidal thoughts or urges (i.e., reducing access to lethal means).
In this study, Safety plan was delivered face-to-face, during the post-ED stay; upon discharge, participants were provided with the paper-based plan they completed with their physician.
The main outcome of our study was to evaluate the feasibility - assessed by healthcare workers- and the acceptability - from patients' point of view- of conducting a Safety plan in a post-ED setting, after suicidal attempt. Secondary outcomes included to evaluate Safety plan utility, assessed by patients based on their use or not of the Safety plan at 1 and 6 months after inclusion, and its efficacy, on the recurrence of suicidal attempt over the 6 months after inclusion.
To evaluate the outcomes at 1 and 6 months, patients were recontacted by a psychologist to complete a brief questionnaire over the phone.
At baseline, we also collected sociodemographics information, including marital status and living situation; patients completed the Hospital anxiety and depression scale, and suicidal ideations evaluated with the Columbia-Suicide Severity Rating Scale (C-SSRS).
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
- All individuals included in the study were patients hospitalized at the post-emergency short-term psychiatric unit following a visit to the emergency room for a suicide attempt. The recruitment took place between June 2022 and December 2023. Patients eligible for inclusion had to be adults, admitted to the hospital following a suicide attempt, and willing to participate in the study. The criteria for non-inclusion were: a) patients who were minors, b) patients who were unable to be informed or to understand the course of the study (if they did not understand French or if their condition did not allow it), c) patients who were opposed to the collection of data for research purposes, d) patients whose psychiatric and/or somatic condition was incompatible with the brief intervention and/or the study questionnaire
Key inclusion criteria (2 listed)
- Patients over 18 years old
- Patients hospitalised in a post-emergency unit following a suicidal attempt
Key exclusion criteria (3 listed)
- Patients whose clinical state or French level prevent to understand the information regarding the study and to consent to the study
- Pattients whose clinical state or French level prevent to participate to the Safety plan intervention
- patients who do not agree to participate
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
Feasibility
Time frame: Day of intervention (D0)
The feasibility of implementing the safety plan was assessed with a questionnaire submitted to the caregivers who delivered the intervention. This self-administered questionnaire assessed: the time required to complete the safety plan, the availability of a suitable location for conducting the interview, the clinical and mood status of the individuals, and the difficulties encountered during the intervention. This questionnaire determined the feasibility score ranging from -4 to 6.
Acceptability
Time frame: Day of intervention (D0)
A questionnaire for patients who had benefited from the safety plan was used to establish an overall acceptability score intervention. This questionnaire, partly based on Stanley's evaluation, allowed to determine an acceptability score, ranging from -8 to 8, a high positive value indicating a higher acceptance of the intervention by the patient. The acceptability score was calculated by summing the responses to the following questions: a) Have you ever had the opportunity to participate in an interview of this type (security plan)? b) Were the questions clear? c) Were there any questions that made you uncomfortable? d) Did you find this interview lengthy? e) Did you find the questions repetitive? f) Do you think you learned anything about yourself from this interview? g) Do you think the security plan can help you in your situation? h) Do you think this document could be useful to you in the future?
2 secondary outcomes
Utility
Time frame: 1 month after discharge
Efficacy
Time frame: Any suicidal attempt occuring up to 6 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 37121806de Ganay M, Duroy D, Perozziello A, Lejoyeux M, Geoffroy PA. Study assessing the feasibility and acceptability of implementing the Safety Plan for suicide prevention in a French emergency department. Encephale. 2023 Dec;49(6):656-657. doi: 10.1016/j.encep.2023.03.002. Epub 2023 Apr 28. No abstract available.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Suicidal Ideations and Suicidal Attempt, run by Centre Hospitalier St Anne at 1 site 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 3 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 12 Jul 2024. 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 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?
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?
Feasibility (time frame: Day of intervention (D0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06499337, which also lists 1 linked publication.
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 12 Jul 2024.