Ecological Momentary Mental Assessment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development of an Algorithm and a Smartphone Application for the Evaluation and Prediction of Suicidal Risk

Conditions
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Person at Risk of Suicide

Intervention / Treatment
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* Other: Application EMMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group using the application EMMA<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | At 6 months | 
| Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 1 month | 
| Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 2 months | 
| Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 3 months | 
| Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 4 months | 
| Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 5 months | 
| Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 6 months | 
| Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS) |  | At 6 months | 
| Acceptability of EMMA assessed by a qualitative interview | The qualitative interview is optional | At 6 months | 
| Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 1 month | 
| Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 2 months | 
| Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 3 months | 
| Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 4 months | 
| Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 5 months | 
| Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 6 months | 
| Satisfaction of EMMA assessed by the satisfaction questionnaire |  | At 6 months | 
| Satisfaction of EMMA assessed by a qualitative interview | The qualitative interview is optional | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatry, Suicide, Prediction, Smartphone application, Ecological Momentary Assessment