Clinical trial NCT03410381: Ecological Momentary Mental Assessment
Official title: Development of an Algorithm and a Smartphone Application for the Evaluation and Prediction of Suicidal Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Person at Risk of Suicide
Keywords: Psychiatry
Suicide
Prediction
Smartphone application
Ecological Momentary Assessment
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: University Hospital, Brest
name: University Hospital Saint jacques, Besançon
name: University Hospital, Henri Mondor/Albert Chenevier, Créteil
First posted: 2018-01-25
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of a suicidal event during the follow-up
timeFrame: At 6 months
Secondary outcomes:
measure: Evaluation of the frequency of connection of the patient to the EMMA application
timeFrame: At 1 month
measure: Evaluation of the frequency of connection of the patient to the EMMA application
timeFrame: At 2 months
measure: Evaluation of the frequency of connection of the patient to the EMMA application
timeFrame: At 3 months
measure: Evaluation of the frequency of connection of the patient to the EMMA application
timeFrame: At 4 months
measure: Evaluation of the frequency of connection of the patient to the EMMA application
timeFrame: At 5 months
measure: Evaluation of the frequency of connection of the patient to the EMMA application
timeFrame: At 6 months
measure: Acceptability of EMMA assessed by the Smartphone application
timeFrame: At 1 month
measure: Acceptability of EMMA assessed by the Smartphone application
timeFrame: At 2 months
measure: Acceptability of EMMA assessed by the Smartphone application
timeFrame: At 3 months
measure: Acceptability of EMMA assessed by the Smartphone application
timeFrame: At 4 months
measure: Acceptability of EMMA assessed by the Smartphone application
timeFrame: At 5 months
measure: Acceptability of EMMA assessed by the Smartphone application
timeFrame: At 6 months
measure: Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS)
timeFrame: At 6 months
measure: Acceptability of EMMA assessed by a qualitative interview
timeFrame: At 6 months
measure: Satisfaction of EMMA assessed by the Smartphone application
timeFrame: At 1 month
measure: Satisfaction of EMMA assessed by the Smartphone application
timeFrame: At 2 months
measure: Satisfaction of EMMA assessed by the Smartphone application
timeFrame: At 3 months
measure: Satisfaction of EMMA assessed by the Smartphone application
timeFrame: At 4 months
measure: Satisfaction of EMMA assessed by the Smartphone application
timeFrame: At 5 months
measure: Satisfaction of EMMA assessed by the Smartphone application
timeFrame: At 6 months
measure: Satisfaction of EMMA assessed by the satisfaction questionnaire
timeFrame: At 6 months
measure: Satisfaction of EMMA assessed by a qualitative interview
timeFrame: At 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: MontpellierUniversity Hopital
Study officials:
References:
citation: 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.