SuicidePreventSNCT07160465
Efficacy of a Smartphone Suicide Prevention App
A study testing emma application in people with Suicide and Suicide Attempt, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Suicide Attempt
- What is being tested?
- emma application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University hospital
Montpellier, 34295
Jessica Dalaudiere, Clinical research coordinator, +33499614569, jessica.dalaudiere@chu-montpellier.fr
About this study
Official title: Efficacy of a Smartphone Suicide Prevention App: A Single-blind, Randomized, Controlled Multicenter Study
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.
Read more
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.
Read the 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.
- Conditions
- Suicide, Suicide Attempt
- Being tested
- emma application
- Keywords
- Suicide, Suicide attempt
- Medical subject headings
- Suicide, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emma applicationOther
- 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).
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 316 suicide attempters will benefit from the VigilanS program alone |
| Interventional group | Experimental | 316 suicide attempters will benefit from the app emma in addition to Vigilans Receives: Other: emma application |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of a suicidal event
The primary endpoint is the occurrence of a suicidal event (suicide, SA, hospitalization, or emergency admission for suicidal ideation) within 6 months of inclusion.
Measured: within 6 months of inclusion.
Secondary outcomes (10)
suicidal ideation
Intensity and severity of suicidal ideation assessed with C-SSRS.
Measured: Up to 6 months after study inclusion
psychological pain
Level of psychological pain assessed by a validated Likert scale.
Measured: Up to 6 months after study inclusion
Level of depression
Level of depression assessed by QIDS
Measured: Up to 6 months after study inclusion
Loneliness
Level of loneliness assessed by ESUL
Measured: Up to 6 months after study inclusion
social isolation
Level of social isolation assessed by ISI
Measured: Up to 6 months after study inclusion
hopelessness
Level of hopelessness assessed by BHS
Measured: Up to 6 months after study inclusion
Objective and subjective connections with the healthcare system
Number of care visits for psychiatric problems and/or suicidal ideation
Measured: number of care visit until the end of the study, an average of 6 months
Objective and subjective connections with the healthcare system
Semi-directive interviews conducted with patients who agree to participate in the qualitative study, to explore experiences related to psychiatric care and suicidal ideation.
Measured: Semi-directive interviews during the visit at 6 months
Objective and subjective experience of the app (interventionnal group only)
Frequency of connection.
Measured: Up to 6 months after study inclusion
Objective and subjective experience of the app (interventionnal group only)
Acceptability and satisfaction of patients assessed by monthly questionnaires in the app (Likert scales), by a self-questionnaire to be completed at the last visit (MARS scale) and, for 30 patients who agree to participate in the qualitative study, during the qualitative evaluation of the experience of emma users.
Measured: within 6 months of inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation FondaMental
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160465
- Sponsor's protocol ID
- RECHMPL20_0072
- Other IDs
- 2024-A02330-47
- Acronym
- PreventS
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Smartphone Suicide Prevention App: A Single-blind, Randomized, Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT07160465
- Acronym / sponsor ID
- PreventS / RECHMPL20_0072
- Conditions
- Suicide, Suicide Attempt
- Keywords
- Suicide, Suicide attempt
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Fondation FondaMental
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Sep 2025 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –316 suicide attempters will benefit from the VigilanS program alone |
| Interventional group | Experimental | Other: emma application316 suicide attempters will benefit from the app emma in addition to Vigilans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emma application1. 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 | Other | Interventional group |
Primary outcome
occurrence of a suicidal event
Time frame: 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.
10 secondary outcomes
suicidal ideation
Time frame: Up to 6 months after study inclusion
psychological pain
Time frame: Up to 6 months after study inclusion
Level of depression
Time frame: Up to 6 months after study inclusion
Loneliness
Time frame: Up to 6 months after study inclusion
social isolation
Time frame: Up to 6 months after study inclusion
hopelessness
Time frame: Up to 6 months after study inclusion
Objective and subjective connections with the healthcare system
Time frame: number of care visit until the end of the study, an average of 6 months
Objective and subjective connections with the healthcare system
Time frame: Semi-directive interviews during the visit at 6 months
Objective and subjective experience of the app (interventionnal group only)
Time frame: Up to 6 months after study inclusion
Objective and subjective experience of the app (interventionnal group only)
Time frame: within 6 months of inclusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emma application in people with Suicide and Suicide Attempt, run by University Hospital, Montpellier 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe COURTET, MD PhD (+33 4 67 33 85 81, p-courtet@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of a suicidal event (time frame: within 6 months of inclusion.). 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 8 Sep 2025.