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SmartCriseS - Smartphone Survey of Suicidal Risk

NCT03720730 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1044

Last updated 2021-12-07

No results posted yet for this study

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.

Conditions

Interventions

OTHER

EMA

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).

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    collaborator OTHER

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    collaborator OTHER

  • INSERM U1061 Neuropsychiatry Montpellier, France

    collaborator UNKNOWN

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2026-01-13
Completion
2026-04-13

Countries

  • France
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03720730 on ClinicalTrials.gov