NCT03720730

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,044

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2026

Completed
Last Updated

December 7, 2021

Status Verified

December 1, 2021

Enrollment Period

7.2 years

First QC Date

October 24, 2018

Last Update Submit

December 6, 2021

Conditions

Personal History of a Recent Suicidal CrisisSuicidal IdeationSuicidal Behaviour

Keywords

Suicidal crisisSuicidal behaviourPreventionSmartphone applicationEcological momentary assessmentPsychiatryFollow-up

Outcome Measures

Primary Outcomes (1)

  • Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

    Evaluate the occurrence of a suicidal event with the C-SSRS. The questionnaire includes four subscales. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.

    6 months

Secondary Outcomes (10)

  • Evaluation of insomnia assessed by ecological momentary assessment (EMA)

    6 months

  • Evaluation of insomnia assessed by Insomnia Severity Index (ISI)

    6 months

  • Evaluation of appetite assessed by ecological momentary assessment (EMA)

    6 months

  • Evaluation of sensibility to social exclusion assessed by ecological momentary assessment (EMA)

    6 months

  • Evaluation of suicidal ideation intensity assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

    6 months

  • +5 more secondary outcomes

Other Outcomes (4)

  • Evaluation of sleep quantity with the actimeter

    1 month

  • Evaluation of sleep quantity with the sleep diary

    1 month

  • Evaluation of sleep quality with the actimeter

    1 month

  • +1 more other outcomes

Study Arms (1)

Study participants

EXPERIMENTAL

Patients with a recent history of suicidal crisis (within the last 7 days) will use a smartphone application to evaluate sleep, appetite and social parameters.

Other: EMA

Interventions

EMAOTHER

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).

Study participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • years old patients and older with an MMSE score \< 24 at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Montpellier

Montpellier, 34295, France

RECRUITING

Fundacion Jimenez Diaz Hospital

Madrid, 28040, Spain

RECRUITING

Related Publications (2)

  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

    PMID: 33884617DERIVED

  • Berrouiguet S, Barrigon ML, Castroman JL, Courtet P, Artes-Rodriguez A, Baca-Garcia E. Combining mobile-health (mHealth) and artificial intelligence (AI) methods to avoid suicide attempts: the Smartcrises study protocol. BMC Psychiatry. 2019 Sep 7;19(1):277. doi: 10.1186/s12888-019-2260-y.

    PMID: 31493783DERIVED

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Central Study Contacts

Jorge Lopez Castroman, MD PhD

CONTACT

+33 4 66 68 34 26Jorge.lopezcastroman@chu-nimes.fr

Enrique Baca-Garcia, MD PhD

CONTACT

ebaca@fjd.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 25, 2018

Study Start

November 13, 2018

Primary Completion

January 13, 2026

Study Completion

April 13, 2026

Last Updated

December 7, 2021

Record last verified: 2021-12

Locations

ES(1)FR(1)