Suicide, Suicide Attempt
Conditions
Keywords
Suicide, Suicide attempt
Brief summary
It is an interventional research, single-blind, randomized, controlled, multicenter, which involves only minimal risks and constraints. Patients who attend to the emergency department following a SA (Suicidal Attempt) represent a key group of patients with an extremely high risk of suicide in the short term. A main problem in suicide prevention is that the increase of symptoms and suicidal risk occurs most often in the natural environment of patients, away from the system of care. Thus, the main goal in allowing real-time risk detection would facilitate immediate interventions, probably the best way to prevent a suicidal act. Additionally, the evolution of the suicidal crisis is very variable from one subject to another, in duration and symptoms, and often very brief. In contrast, the tools used to assess suicidal thoughts have so far been limited to intermittent assessments separated by weeks, months or years, which does not take into account the fact that suicidal thoughts can be highly variable over a few hours and that suicide attempts can occur in response to a rapid increase in thoughts over periods as short as the day. Mobile health (mHealth) interventions are the only that can respond to these fluctuations over time. We have developed the first French app (emma) for EMA (Ecological Momentary Assessment) , customised EMI (Ecological Momentary Intervention) and prediction of SB (suicidal behaviour). It was designed by integrating evidence-based suicide prevention strategies and recommendations for the development of apps in the field of mental health. Emma helps to strengthen the patient's connection to his healthcare system and social network. This study led to the development and subsequent deployment of VigilanS. VigilanS is a multi-regional innovative care program for the prevention of suicide relapse, which has been implemented in several emergencies departments in France. Our hypothesis is that emma offers an unprecedented opportunity to increase the efficiency of VigilanS, both for patients, by restoring their social connections, and for health professionals, in a simple, fast and efficient way. Thanks to emma, the patient will have daily support adapted to his condition (emotion management modules, safety plan, calls in case of emergency). Emma will fit easily into the daily practice of health professionals (little binding, little time consuming) and will complete the range of care organized by VigilanS. The main objective is to evaluate over a 6-months follow-up the efficacy of a smartphone app (emma) in addition to the VigilanS program on the prevention of a suicidal event (suicide, SA, hospitalization or emergency department for suicidal ideation) compared to the VigilanS program only.
Detailed description
632 participants will be enrolled and randomized into 2 groups: * Control group: 316 suicide attempters will benefit from the VigilanS program alone * Interventional group: 316 suicide attempters will benefit from the emma app in addition to VigilanS The duration of inclusions is 24 months. Each patient's participation period is 6 months and includes three visits (inclusion, at 3 and 6 months). At each visit, a clinical assessment will be performed to characterise psychopathology and suicidal characteristics.
Interventions
OTHERemma application
1. Emma will allow the patient to spontaneously contact the VigilanS tele-clinician team via a simple and quick access (when the patient presses an ergonomic button with the VigilanS logo). He can also contact the National Service for Suicide Prevention (3114) or the French national emergency medical assistance service 24/7 (Samu). 2. Experts of the field have defined response thresholds for targeted questions on suicide risk and emotional tension. If the patient's answers to these questions reach these thresholds, emma will automatically send a message to the nearest VigilanS center. In this case, a message will appear indicating to the patient that the nearest center will contact him as soon as possible, encourage him to review his strategies and resources available on the app's Home and direct him to the breathing space. 3. Emma offers a Safety Plan module that will allow the patient to help him/her to put into practice what he/she will develop with the VigilanS team on a daily bas
Sponsors
Fondation FondaMental
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject aged 18 or over * Subject benefiting from the VigilanS program (after an admission to an emergency ward following a suicide attempt) * Subject with his own smartphone (iOS/Androïd) * Subject able to understand the nature, purpose and methodology of the study * Subject must be covered by public health insurance * Signed informed consent form
Exclusion criteria
* Subject unable to read or/and write French * Planned longer stay outside the region that prevents compliance with the visit plan * Being protected by the law (tutorship or curatorship) * Being deprived of liberty by administrative decision * Being in a period of exclusion compared to another protocol * Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of a suicidal event | within 6 months of inclusion. | The primary endpoint is the occurrence of a suicidal event (suicide, SA, hospitalization, or emergency admission for suicidal ideation) within 6 months of inclusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| psychological pain | Up to 6 months after study inclusion | Level of psychological pain assessed by a validated Likert scale. |
| Level of depression | Up to 6 months after study inclusion | Level of depression assessed by QIDS |
| Loneliness | Up to 6 months after study inclusion | Level of loneliness assessed by ESUL |
| suicidal ideation | Up to 6 months after study inclusion | Intensity and severity of suicidal ideation assessed with C-SSRS. |
| hopelessness | Up to 6 months after study inclusion | Level of hopelessness assessed by BHS |
| Objective and subjective connections with the healthcare system | number of care visit until the end of the study, an average of 6 months | Number of care visits for psychiatric problems and/or suicidal ideation |
| Objective and subjective experience of the app (interventionnal group only) | Up to 6 months after study inclusion | Frequency of connection. |
| social isolation | Up to 6 months after study inclusion | Level of social isolation assessed by ISI |
Countries
France
Contacts
Primary ContactPhilippe COURTET, MD PhD
Backup ContactEmilie OLIE, MD PhD
Outcome results
None listed