Person at Risk of SuicideEMMANCT03410381
Ecological Momentary Mental Assessment
A study testing Application EMMA in people with Person at Risk of Suicide, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Suicide is a major health problem that causes annually a million death worldwide. Suicide and suicide attempts are preventable. A history of self-injuries or suicidal attempts are known to be the most important risk factor for death by suicide. Suicidal ideation is also strongly correlated with suicide attempts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Person at Risk of Suicide
- What is being tested?
- Application EMMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2018to 26 Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- Recent suicidal attempt (< 8 days) or suicidal ideation score ≥ 2 (IDSC-30 scale)
- More than 18 years old
- Able to understand nature, aims, and methodology oh the study
- To own a smartphone
Who cannot join
- Refusal to participate
- Patient on protective measures (guardianship or trusteeship)
- Deprived of liberty subject (administrative decision)
- Subject in exclusion period for another protocol
- Not affiliated to a social security agency
- Unable to understand and/or answer a questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Algorithm and a Smartphone Application for the Evaluation and Prediction of Suicidal Risk
Suicide is a major health problem that causes annually a million death worldwide. Suicide and suicide attempts are preventable.
A history of self-injuries or suicidal attempts are known to be the most important risk factor for death by suicide. Suicidal ideation is also strongly correlated with suicide attempts.
Read more
The development of Smartphones applications offers new possibilities for data collection and transmission.
Moreover, the online help function, when a suicidal crisis occurs, is the most effective strategy for prevention of suicidal behavior.
Specific technologies have been developed to analyse behaviors and experiences of patients in a natural environment, in real life.
That is the goal of Ecological Momentary Assessment.
The aim of the study is to develop an algorithm to assess and predict the risk of suicidal event occurrence, in order to detect as soon as possible the signs of suicidal crisis.
EMMA will be the first application in French, meeting the recommendations for health applications, developed by experts on suicidal behavior and in collaboration with patients which aims to predict suicidal risk.
A subsequent study, conducted on a larger population, should allow to validate the predictive algorithm of EMMA.
Long-term goal is to improve the care of patients at risk for suicidal behavior.
Read the detailed description
100 patients having recently attempted suicide or having suicidal ideation will be recruited. They will be asked to use the application EMMA during 6 months and will be followed up during this period.
An optional qualitative study conducted on 25 patients will allow to evaluate more finely their subjective experience of the use of the application.
Initial visit (inclusion) : clinical, biological and neuropsychological assessment and installation of the application EMMA.
First visit (1st month) and second visit (3rd month) : clinical assessment
Last visit (6th month) : clinical, biological and neuropsychological assessment and optional qualitative interview.
- Conditions
- Person at Risk of Suicide
- Being tested
- Application EMMA
- Keywords
- Psychiatry, Suicide, Prediction, Smartphone application, Ecological Momentary Assessment
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application EMMAOther
Emma proposes four types of assessments during 6 months:1) 5 times a day during 3 days, every month (5 minutes): patients can assess their emotions, their thoughts, their behavior and their occurrence context. 2) Weekly (7 minutes): consists of a summary of the week, about their emotions, thoughts, behavior, their relationships (family, work, friends, and their quality of life.3) Monthly (5 minutes): assessment of the usefulness and satisfaction about the application.4) Assessment available at any time An action plan is designed to support the participants, to help them facing difficult emotions and feelings, and to encourage them to ask for help. They can contact a relative or call the psychiatric emergency service directly by clicking on a button.
| Study group | Role | What they receive |
|---|---|---|
| Group using the application EMMA | Experimental | Patients with personal history of suicide attempt or with suicidal ideation, will use the application during 6 months. Assessment of the predictive value of the algorithm for suicidal risk, acceptbability and satisfaction Receives: Other: Application EMMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a suicidal event during the follow-up
Occurrence of a suicidal event will be checked by the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire and medical records at the end of study.
Measured: At 6 months
Secondary outcomes (22)
Evaluation of the frequency of connection of the patient to the EMMA application
The use is automatically measured by the application with the connection frequency
Measured: At 1 month
Evaluation of the frequency of connection of the patient to the EMMA application
The use is automatically measured by the application with the connection frequency
Measured: At 2 months
Evaluation of the frequency of connection of the patient to the EMMA application
The use is automatically measured by the application with the connection frequency
Measured: At 3 months
Evaluation of the frequency of connection of the patient to the EMMA application
The use is automatically measured by the application with the connection frequency
Measured: At 4 months
Evaluation of the frequency of connection of the patient to the EMMA application
The use is automatically measured by the application with the connection frequency
Measured: At 5 months
Evaluation of the frequency of connection of the patient to the EMMA application
The use is automatically measured by the application with the connection frequency
Measured: At 6 months
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 1 month
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 2 months
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 3 months
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 4 months
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 5 months
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 6 months
Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS)
Measured: At 6 months
Acceptability of EMMA assessed by a qualitative interview
The qualitative interview is optional
Measured: At 6 months
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 1 month
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 2 months
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 3 months
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 4 months
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 5 months
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Measured: At 6 months
Satisfaction of EMMA assessed by the satisfaction questionnaire
Measured: At 6 months
Satisfaction of EMMA assessed by a qualitative interview
The qualitative interview is optional
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start31 May 2018
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
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 Person at Risk of SuicideStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Brest, University Hospital Saint jacques, Besançon, University Hospital, Henri Mondor/Albert Chenevier, Créteil
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410381
- Sponsor's protocol ID
- 9867
- Other IDs
- 2017-A22108-45
- Acronym
- EMMA
- Status last verified
- Jan 2021
- First submitted
- 14 Dec 2017
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morgieve M, Genty C, Aze J, Dubois J, Leboyer M, Vaiva G, Berrouiguet S, Courtet P. A Digital Companion, the Emma App, for Ecological Momentary Assessment and Prevention of Suicide: Quantitative Case Series Study. JMIR Mhealth Uhealth. 2020 Oct 9;8(10):e15741. doi: 10.2196/15741.
PubMed 33034567
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Algorithm and a Smartphone Application for the Evaluation and Prediction of Suicidal Risk
- ClinicalTrials.gov ID
- NCT03410381
- Acronym / sponsor ID
- EMMA / 9867
- Conditions
- Person at Risk of Suicide
- Keywords
- Psychiatry, Suicide, Prediction, Smartphone application, Ecological Momentary Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Brest, University Hospital Saint jacques, Besançon, University Hospital, Henri Mondor/Albert Chenevier, Créteil
- Study start
- 31 May 2018 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 25 Jan 2018 (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 a major health problem that causes annually a million death worldwide. Suicide and suicide attempts are preventable.
A history of self-injuries or suicidal attempts are known to be the most important risk factor for death by suicide. Suicidal ideation is also strongly correlated with suicide attempts.
The development of Smartphones applications offers new possibilities for data collection and transmission.
Moreover, the online help function, when a suicidal crisis occurs, is the most effective strategy for prevention of suicidal behavior.
Specific technologies have been developed to analyse behaviors and experiences of patients in a natural environment, in real life.
That is the goal of Ecological Momentary Assessment.
The aim of the study is to develop an algorithm to assess and predict the risk of suicidal event occurrence, in order to detect as soon as possible the signs of suicidal crisis.
EMMA will be the first application in French, meeting the recommendations for health applications, developed by experts on suicidal behavior and in collaboration with patients which aims to predict suicidal risk.
A subsequent study, conducted on a larger population, should allow to validate the predictive algorithm of EMMA.
Long-term goal is to improve the care of patients at risk for suicidal behavior.
Detailed description
100 patients having recently attempted suicide or having suicidal ideation will be recruited. They will be asked to use the application EMMA during 6 months and will be followed up during this period.
An optional qualitative study conducted on 25 patients will allow to evaluate more finely their subjective experience of the use of the application.
Initial visit (inclusion) : clinical, biological and neuropsychological assessment and installation of the application EMMA.
First visit (1st month) and second visit (3rd month) : clinical assessment
Last visit (6th month) : clinical, biological and neuropsychological assessment and optional qualitative interview.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group using the application EMMA | Experimental | Other: Application EMMAPatients with personal history of suicide attempt or with suicidal ideation, will use the application during 6 months. Assessment of the predictive value of the algorithm for suicidal risk, acceptbability and satisfaction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recent suicidal attempt (< 8 days) or suicidal ideation score ≥ 2 (IDSC-30 scale)
- More than 18 years old
- Able to understand nature, aims, and methodology oh the study
- To own a smartphone
Key exclusion criteria (6 listed)
- Refusal to participate
- Patient on protective measures (guardianship or trusteeship)
- Deprived of liberty subject (administrative decision)
- Subject in exclusion period for another protocol
- Not affiliated to a social security agency
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 |
|---|---|---|
| Application EMMAEmma proposes four types of assessments during 6 months:1) 5 times a day during 3 days, every month (5 minutes): patients can assess their emotions, their thoughts, their behavior and their occurrence context. 2) Weekly (7 minutes): consists of a summary of the week, about their emotions, thoughts, behavior, their relationships (family, work, friends, and their quality of life.3) Monthly (5 minutes): assessment of the usefulness and satisfaction about the application.4) Assessment available at any time An action plan is designed to support the participants, to help them facing difficult emotions and feelings, and to encourage them to ask for help. They can contact a relative or call the psychiatric emergency service directly by clicking on a button. | Other | Group using the application EMMA |
Primary outcome
Occurrence of a suicidal event during the follow-up
Time frame: At 6 months
Occurrence of a suicidal event will be checked by the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire and medical records at the end of study.
22 secondary outcomes
Evaluation of the frequency of connection of the patient to the EMMA application
Time frame: At 1 month
Evaluation of the frequency of connection of the patient to the EMMA application
Time frame: At 2 months
Evaluation of the frequency of connection of the patient to the EMMA application
Time frame: At 3 months
Evaluation of the frequency of connection of the patient to the EMMA application
Time frame: At 4 months
Evaluation of the frequency of connection of the patient to the EMMA application
Time frame: At 5 months
Evaluation of the frequency of connection of the patient to the EMMA application
Time frame: At 6 months
Acceptability of EMMA assessed by the Smartphone application
Time frame: At 1 month
Acceptability of EMMA assessed by the Smartphone application
Time frame: At 2 months
Acceptability of EMMA assessed by the Smartphone application
Time frame: At 3 months
Acceptability of EMMA assessed by the Smartphone application
Time frame: At 4 months
Acceptability of EMMA assessed by the Smartphone application
Time frame: At 5 months
Acceptability of EMMA assessed by the Smartphone application
Time frame: At 6 months
Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS)
Time frame: At 6 months
Acceptability of EMMA assessed by a qualitative interview
Time frame: At 6 months
Satisfaction of EMMA assessed by the Smartphone application
Time frame: At 1 month
Satisfaction of EMMA assessed by the Smartphone application
Time frame: At 2 months
Satisfaction of EMMA assessed by the Smartphone application
Time frame: At 3 months
Satisfaction of EMMA assessed by the Smartphone application
Time frame: At 4 months
Satisfaction of EMMA assessed by the Smartphone application
Time frame: At 5 months
Satisfaction of EMMA assessed by the Smartphone application
Time frame: At 6 months
Satisfaction of EMMA assessed by the satisfaction questionnaire
Time frame: At 6 months
Satisfaction of EMMA assessed by a qualitative interview
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Derived from this study: PubMed 33034567Morgieve M, Genty C, Aze J, Dubois J, Leboyer M, Vaiva G, Berrouiguet S, Courtet P. A Digital Companion, the Emma App, for Ecological Momentary Assessment and Prevention of Suicide: Quantitative Case Series Study. JMIR Mhealth Uhealth. 2020 Oct 9;8(10):e15741. doi: 10.2196/15741.
- Individual participant dataSharing planned: No
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?
A study testing Application EMMA in people with Person at Risk of Suicide, 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 4 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: finished, as of the sponsor's last update on 5 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of a suicidal event during the follow-up (time frame: At 6 months). 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 NCT03410381, 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 5 Feb 2021; AzTrials last refreshed its copy on 29 Oct 2026.