Ecological Momentary Mental Assessment

Not Applicable

Completed

• Conditions: Person at Risk of Suicide
• Interventions: Other: Application EMMA

• Registration Number: NCT03410381
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

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 Timeline

• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-25
• Study Start: 2018-05-31
• Primary Completion: 2020-06-26
• Study Completion: 2020-06-26
• Status Verified: 2021-01
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group using the application EMMA	Application EMMA	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

Primary Outcome Measures

Name	Time	Method
Occurrence of a suicidal event during the follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the frequency of connection of the patient to the EMMA application	At 6 months	The use is automatically measured by the application with the connection frequency
Satisfaction of EMMA assessed by a qualitative interview	At 6 months	The qualitative interview is optional
Acceptability of EMMA assessed by the Smartphone application	At 6 months	Questionnaire passed with the application (Likert scales)
Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS)	At 6 months
Satisfaction of EMMA assessed by the satisfaction questionnaire	At 6 months
Acceptability of EMMA assessed by a qualitative interview	At 6 months	The qualitative interview is optional
Satisfaction of EMMA assessed by the Smartphone application	At 6 months	Questionnaire passed with the application (Likert scales)

Trial Locations

Locations (1)

MontpellierUniversity Hopital; 🇫🇷 Montpellier, France