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Ecological Momentary Mental Assessment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03410381
Acronym
EMMA
Enrollment
97
Registered
2018-01-25
Start date
2018-05-31
Completion date
2020-06-26
Last updated
2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Person at Risk of Suicide

Keywords

Psychiatry, Suicide, Prediction, Smartphone application, Ecological Momentary Assessment

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.

Interventions

OTHERApplication 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.

Sponsors

University Hospital, Lille
CollaboratorOTHER
University Hospital, Brest
CollaboratorOTHER
University Hospital Saint jacques, Besançon
CollaboratorUNKNOWN
University Hospital, Henri Mondor/Albert Chenevier, Créteil
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of a suicidal event during the follow-upAt 6 monthsOccurrence 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

MeasureTime frameDescription
Acceptability of EMMA assessed by the Smartphone applicationAt 1 monthQuestionnaire passed with the application (Likert scales)
Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS)At 6 months
Acceptability of EMMA assessed by a qualitative interviewAt 6 monthsThe qualitative interview is optional
Evaluation of the frequency of connection of the patient to the EMMA applicationAt 1 monthThe use is automatically measured by the application with the connection frequency
Satisfaction of EMMA assessed by the satisfaction questionnaireAt 6 months
Satisfaction of EMMA assessed by a qualitative interviewAt 6 monthsThe qualitative interview is optional
Satisfaction of EMMA assessed by the Smartphone applicationAt 1 monthQuestionnaire passed with the application (Likert scales)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026