Ecological Momentary Mental Assessment (EMMA)

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.

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.

Study Overview

• Status: Completed
• Conditions: Person at Risk of Suicide
• Intervention / Treatment: Other: Application EMMA

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • MontpellierUniversity Hopital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Group using the 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

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University Hospital, Brest; University Hospital, Lille; University Hospital Saint jacques, Besançon; University Hospital, Henri Mondor/Albert Chenevier, Créteil

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Psychiatry; Suicide; Prediction; Ecological Momentary Assessment; Smartphone application
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: 9867; 2017-A22108-45 (Other Identifier: Agence Nationale de Securité des Médicaments et produist de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No