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Ecological Momentary Mental Assessment (EMMA)

Primary Purpose

Person at Risk of Suicide

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Application EMMA
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Person at Risk of Suicide focused on measuring Psychiatry, Suicide, Prediction, Smartphone application, Ecological Momentary Assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MontpellierUniversity Hopital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group using the application EMMA

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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
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
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
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Acceptability of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS)
Acceptability of EMMA assessed by a qualitative interview
The qualitative interview is optional
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Satisfaction of EMMA assessed by the Smartphone application
Questionnaire passed with the application (Likert scales)
Satisfaction of EMMA assessed by the satisfaction questionnaire
Satisfaction of EMMA assessed by a qualitative interview
The qualitative interview is optional

Full Information

First Posted
December 14, 2017
Last Updated
February 4, 2021
Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Lille, University Hospital, Brest, University Hospital Saint jacques, Besançon, University Hospital, Henri Mondor/Albert Chenevier, Créteil
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1. Study Identification

Unique Protocol Identification Number
NCT03410381
Brief Title
Ecological Momentary Mental Assessment
Acronym
EMMA
Official Title
Development of an Algorithm and a Smartphone Application for the Evaluation and Prediction of Suicidal Risk
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Lille, University Hospital, Brest, University Hospital Saint jacques, Besançon, University Hospital, Henri Mondor/Albert Chenevier, Créteil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Person at Risk of Suicide
Keywords
Psychiatry, Suicide, Prediction, Smartphone application, Ecological Momentary Assessment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group using the application EMMA
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Application EMMA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of a suicidal event during the follow-up
Description
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.
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Evaluation of the frequency of connection of the patient to the EMMA application
Description
The use is automatically measured by the application with the connection frequency
Time Frame
At 1 month
Title
Evaluation of the frequency of connection of the patient to the EMMA application
Description
The use is automatically measured by the application with the connection frequency
Time Frame
At 2 months
Title
Evaluation of the frequency of connection of the patient to the EMMA application
Description
The use is automatically measured by the application with the connection frequency
Time Frame
At 3 months
Title
Evaluation of the frequency of connection of the patient to the EMMA application
Description
The use is automatically measured by the application with the connection frequency
Time Frame
At 4 months
Title
Evaluation of the frequency of connection of the patient to the EMMA application
Description
The use is automatically measured by the application with the connection frequency
Time Frame
At 5 months
Title
Evaluation of the frequency of connection of the patient to the EMMA application
Description
The use is automatically measured by the application with the connection frequency
Time Frame
At 6 months
Title
Acceptability of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 1 month
Title
Acceptability of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 2 months
Title
Acceptability of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 3 months
Title
Acceptability of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 4 months
Title
Acceptability of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 5 months
Title
Acceptability of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 6 months
Title
Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS)
Time Frame
At 6 months
Title
Acceptability of EMMA assessed by a qualitative interview
Description
The qualitative interview is optional
Time Frame
At 6 months
Title
Satisfaction of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 1 month
Title
Satisfaction of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 2 months
Title
Satisfaction of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 3 months
Title
Satisfaction of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 4 months
Title
Satisfaction of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 5 months
Title
Satisfaction of EMMA assessed by the Smartphone application
Description
Questionnaire passed with the application (Likert scales)
Time Frame
At 6 months
Title
Satisfaction of EMMA assessed by the satisfaction questionnaire
Time Frame
At 6 months
Title
Satisfaction of EMMA assessed by a qualitative interview
Description
The qualitative interview is optional
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
MontpellierUniversity Hopital
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33034567
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.
Results Reference
derived

Learn more about this trial

Ecological Momentary Mental Assessment

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