RecruitingNot ApplicableNCT03720730

SmartCriseS - Smartphone Survey of Suicidal Risk

Sleep and Appetite Measures as Suicidal Risk Factors in a French- Spanish Cohort of Suicidal Patients.


Sponsor

University Hospital, Montpellier

Enrollment

1,044 participants

Start Date

Nov 13, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

Sleep and appetite disorders as well as social exclusion, have been linked to the emergence of suicidal ideation (SI) and suicide attempts.This study aims to evaluate the relationship between those factors and suicidal ideation and behaviour. To assess those factors an ecological momentary assessment (EMA) desing will be used. EMA will be carried out using 2 applications integrated into the smartphone of participants (Android or iOS), one to make an explicit data collection with questions and another one for the implicit collection of data from mobile sensors. 1044 suicide attempters will be included in three sites and followed for 6 months. Participants will be evaluated at inclusion and at the end of follow-up. The hypothesis is that sleep, appetite and social exclusion factors collected with the smartphone application will be linked to the intensity of death wish, suicidal ideations and suicidal attempts. An auxiliary study will also be led with 300 patients carrying an actimeter for the 30 first days after inclusion. This will help collecting more accurate data on various sleep parameters.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • To be at least 18 years old
  • To use a smartphone as a personal phone
  • To have consulted in the context of a suicidal crisis within the last 7 days
  • To be able to understand the nature, purpose and methodoly of the study.
  • To be in a minimal treatment phase (according to the clinician's judgment).
  • To accept participating to the study and the 6 months follow-up and to have signed the informed consent

Exclusion Criteria7

  • Refusal of participation
  • Subject protected by law (guardianship)
  • Deprived of liberty Subject (by judicial or administrative decision)
  • Diagnosis of a current hypomanic, manic or mixed episode, or a diagnosis of schizoaffective disorder or schizophrenia.
  • No affiliation to the social safety system
  • Exclusion period in relation to another protocol
  • years old patients and older with an MMSE score < 24 at baseline

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Interventions

OTHEREMA

The mobile application (EMA) combines an explicit data collection with an implicit one. For the explicit data collection with Memind application, patients will have to answer specific questionnaires about sleep, appetite and social factors. Some of the questions will be asked on regular basis, at the same time everyday, while others will be asked randomly during the day (between 9 a.m and 9 p.m). The implicit data collecting will be carried out using smartphone sensors (application eB2).


Locations(2)

CHU Montpellier

Montpellier, France

Fundacion Jimenez Diaz Hospital

Madrid, Spain

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NCT03720730


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