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Smartphone-based Ecological Momentary Intervention for Suicide Prevention: a Randomised Clinical Trial

NCT04775160 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-09-08

No results posted yet for this study

Summary

Introduction: Suicide is one of the leading public health issues worldwide. Mobile health can help us to combat suicide through monitoring and treatment. The SmartCrisis 2.0 randomized clinical trial aims to evaluate the effectiveness of a smartphone-based Ecological Momentary Intervention to prevent suicidal thoughts and behaviour.

Methods and analysis: The SmartCrisis 2.0 study is a randomized clinical trial with two parallel groups, conducted among patients with a history of suicidal behaviour treated at the University Hospital Fundación Jiménez Díaz. The intervention group will be monitored using Ecological Momentary Assessment and will receive an Ecological Momentary Intervention called 'SmartSafe' in addition to their treatment as usual (TAU). TAU will consist of psychiatric follow-up of the patient (scheduled appointments with a psychiatrist) in our outpatient Suicide Prevention clinic, with predetermined clinical appointments according to the Brief Intervention Contact recommendations (1, 2, 4, 7 and 11 weeks, and 4, 6, 9 and 12 months). The control group would receive TAU and be monitored using EMA.

Ethics and dissemination: This study has been approved by the Ethics Committee of the University Hospital Fundación Jiménez Díaz. It is expected that, in the near future, the mobile applications MEmind and eB2 can be implemented in routine clinical practice. Results will be disseminated through peer-reviewed journals and psychiatric congresses.

Conditions

  • Suicide

Interventions

DEVICE

SmartSafe

The SmartSafe Ecological Momentary Intervention is contained in the MEmind smartphone application and consists of a Safety plan, an Enhanced contact via app (app-EC) intervention, and a "mental toolbox". The Safety plan is a set of personalized coping strategies that the patient can use in a suicidal crisis. Our safety plan was adapted to a digital environment, including the possibility to activate pre-recorded messages, lead to websites with health resources, or put the patient in contact with the emergency services. The Enhanced contact via app (app-EC) intervention is inspired by the SIAM project and consists in messages that will be sent via the MEmind app inquiring patients about their mental well-being and informing them of the means to request preferential or urgent care. The mental toolbox contains videos relaxation techniques videos and behavioral activation and mentalization exercises.

Sponsors & Collaborators

  • Centre Hospitalier Régional Universitaire Montpellier

    collaborator OTHER

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Maria L Barrigon, PhD · Instituto de Investigación Fundación Jiménez Díaz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2025-05-19
Completion
2025-12-31

Countries

  • Spain

Study Locations

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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 NCT04775160 on ClinicalTrials.gov