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Studies

Interventional Recruiting

NCT04775160 on ClinicalTrials.gov

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

Official title: Smartphone-based Ecological Momentary Intervention for Secondary Prevention of Suicidal Thoughts and Behavior: a Randomised Clinical Trial

  • Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
  • Collaborators: Centre Hospitalier Régional Universitaire Montpellier
  • Enrollment: 220 (Estimated)
  • Study start: 2022-05-20 (Actual)
  • Primary completion: 2028-05-19 (Estimated)
  • Study completion: 2028-12-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Double (Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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

Intervention / Treatment

  • Device: SmartSafe

Primary Outcome Measures

  • Reduction of suicidal ideation (6 months)
    Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale
  • Reduction of suicidal ideation (1 year)
    Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale

Countries

Spain

Locations and Investigators

  • Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain (Recruiting)
    • Alejandro Porras Segovia, PhD

Study Officials

  • Maria L Barrigon, PhD (Principal Investigator) — Instituto de Investigación Fundación Jiménez Díaz