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Ecological Momentary Mental Assessment (EMMA)

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ClinicalTrials.gov Identifier: NCT03410381
Recruitment Status : Not yet recruiting
First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
University Hospital, Lille
University Hospital, Brest
University Hospital Saint jacques, Besançon
University Hospital, Henri Mondor/Albert Chenevier, Créteil
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Person at Risk of Suicide Other: Application EMMA Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of an Algorithm and a Smartphone Application for the Evaluation and Prediction of Suicidal Risk
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.




Primary Outcome Measures :
  1. Occurrence of a suicidal event during the follow-up [ Time Frame: 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 :
  1. Evaluation of the frequency of connection of the patient to the EMMA application [ Time Frame: At 1 month ]
    The use is automatically measured by the application with the connection frequency

  2. Evaluation of the frequency of connection of the patient to the EMMA application [ Time Frame: At 2 months ]
    The use is automatically measured by the application with the connection frequency

  3. Evaluation of the frequency of connection of the patient to the EMMA application [ Time Frame: At 3 months ]
    The use is automatically measured by the application with the connection frequency

  4. Evaluation of the frequency of connection of the patient to the EMMA application [ Time Frame: At 4 months ]
    The use is automatically measured by the application with the connection frequency

  5. Evaluation of the frequency of connection of the patient to the EMMA application [ Time Frame: At 5 months ]
    The use is automatically measured by the application with the connection frequency

  6. Evaluation of the frequency of connection of the patient to the EMMA application [ Time Frame: At 6 months ]
    The use is automatically measured by the application with the connection frequency

  7. Acceptability of EMMA assessed by the Smartphone application [ Time Frame: At 1 month ]
    Questionnaire passed with the application (Likert scales)

  8. Acceptability of EMMA assessed by the Smartphone application [ Time Frame: At 2 months ]
    Questionnaire passed with the application (Likert scales)

  9. Acceptability of EMMA assessed by the Smartphone application [ Time Frame: At 3 months ]
    Questionnaire passed with the application (Likert scales)

  10. Acceptability of EMMA assessed by the Smartphone application [ Time Frame: At 4 months ]
    Questionnaire passed with the application (Likert scales)

  11. Acceptability of EMMA assessed by the Smartphone application [ Time Frame: At 5 months ]
    Questionnaire passed with the application (Likert scales)

  12. Acceptability of EMMA assessed by the Smartphone application [ Time Frame: At 6 months ]
    Questionnaire passed with the application (Likert scales)

  13. Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS) [ Time Frame: At 6 months ]
  14. Acceptability of EMMA assessed by a qualitative interview [ Time Frame: At 6 months ]
    The qualitative interview is optional

  15. Satisfaction of EMMA assessed by the Smartphone application [ Time Frame: At 1 month ]
    Questionnaire passed with the application (Likert scales)

  16. Satisfaction of EMMA assessed by the Smartphone application [ Time Frame: At 2 months ]
    Questionnaire passed with the application (Likert scales)

  17. Satisfaction of EMMA assessed by the Smartphone application [ Time Frame: At 3 months ]
    Questionnaire passed with the application (Likert scales)

  18. Satisfaction of EMMA assessed by the Smartphone application [ Time Frame: At 4 months ]
    Questionnaire passed with the application (Likert scales)

  19. Satisfaction of EMMA assessed by the Smartphone application [ Time Frame: At 5 months ]
    Questionnaire passed with the application (Likert scales)

  20. Satisfaction of EMMA assessed by the Smartphone application [ Time Frame: At 6 months ]
    Questionnaire passed with the application (Likert scales)

  21. Satisfaction of EMMA assessed by the satisfaction questionnaire [ Time Frame: At 6 months ]
  22. Satisfaction of EMMA assessed by a qualitative interview [ Time Frame: At 6 months ]
    The qualitative interview is optional



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410381


Contacts
Contact: Philippe COURTET, MDPhD +33 4 67 33 85 81 p-courtet@chu-montpellier.fr

Sponsors and Collaborators
University Hospital, Montpellier
University Hospital, Lille
University Hospital, Brest
University Hospital Saint jacques, Besançon
University Hospital, Henri Mondor/Albert Chenevier, Créteil

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03410381     History of Changes
Other Study ID Numbers: 9867
2017-A22108-45 ( Other Identifier: Agence Nationale de Securité des Médicaments et produist de santé )
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Psychiatry
Suicide
Prediction
Smartphone application
Ecological Momentary Assessment

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms