NCT06499337

Brief 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 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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1.6 years

First QC Date

July 4, 2024

Last Update Submit

July 11, 2024

Conditions

Keywords

Safety planSuicidal attemptfeasabilityacceptability

Outcome Measures

Primary Outcomes (2)

  • 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.

    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?

    Day of intervention (D0)

Secondary Outcomes (2)

  • Utility

    1 month after discharge

  • Efficacy

    Any suicidal attempt occuring up to 6 months after inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patients over 18 years old
  • Patients hospitalised in a post-emergency unit following a suicidal attempt

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHU Paris Psychiatrie et Neurosciences

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

  • 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.

    PMID: 37121806BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

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

Study Record Dates

First Submitted

July 4, 2024

First Posted

July 12, 2024

Study Start

June 1, 2022

Primary Completion

December 23, 2023

Study Completion

July 31, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations