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Completed

NCT Number: NCT03410381

Ecological Momentary Mental Assessment

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.

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Key information

Conditions

Person at Risk of Suicide Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MontpellierUniversity Hopital

Montpellier, 34000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application EMMA

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • University Hospital Saint jacques, Besançon
  • University Hospital, Brest
  • University Hospital, Henri Mondor/Albert Chenevier, Créteil
  • University Hospital, Lille

Registry information

Official study title

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

Acronym: EMMA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2018
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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