An interventional study of Application EMMA in Person at Risk of Suicide, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
Among 21 studies in Suicide by University Hospital, Montpellier — 7 open to participants now, 8 under way, none of them phase 3. Suicide · University Hospital, Montpellier.
Among the 21 studies in Suicide by University Hospital, Montpellier, this one is the 10th largest by enrollment of the 15 interventional ones, is the only one that started in 2018, is one of 15 with no phase, and was the 7th registered.
607 studies on the registry are indexed under Suicide; 162 are open to participants now.
This study's enrollment of 97 is close to the median of 104 across 490 interventional studies indexed under Suicide.
Browse Suicide studies →7 of the 21 studies in Suicide by University Hospital, Montpellier are open now, in 1 country. Each count lists the studies.
Of the 114 Suicide studies recruiting now, 54 (47%) set no upper age limit and 57 (50%) stop at 75 or younger; 52 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 1 started in 2018.
Median enrollment 120 across the 15 interventional studies, 143 across the 6 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
2 of the studies in Suicide by University Hospital, Montpellier that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07430566University Hospital, MontpellierTrauma Exposure and Suicidal Behaviors in Adolescents Aged 11-17 Hospitalized in Child and Adolescent Psychiatry | 2027-03 |
| NCT05227183University Hospital, MontpellierPrevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis | 2027-03-13 |
Among the 21 studies in Suicide by University Hospital, Montpellier, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Other: Application EMMA
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.
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.
Time frame: At 6 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 6 months
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Time frame: At 1 month
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Time frame: At 2 months
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Time frame: At 3 months
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Time frame: At 4 months
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Time frame: At 5 months
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
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
The qualitative interview is optional
Time frame: At 6 months
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Time frame: At 1 month
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Time frame: At 2 months
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Time frame: At 3 months
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Time frame: At 4 months
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Time frame: At 5 months
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
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
The qualitative interview is optional
Time frame: At 6 months
Plan to share: No
Ran from May 2018 to primary completion in Jun 2020, 24 months.
Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 24 months is below that.
Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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