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

Study acronym: SmartCrisis2
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: May 19, 2025 to May 19, 2028
    • Study completion date: Dec 31, 2025 to Dec 31, 2028
    • Study description expanded, about 8 words
    • Site details revised
  2. Notable Start date: Aug 20, 2021 to May 20, 2022v4 Show 4 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Primary completion date: Dec 31, 2024 to May 19, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    • Site details revised
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2021 to Aug 20, 2021
    v3
  4. Minor Secondary endpoints revised (8)
    • Study description shortened, about 102 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04775160
Lead Sponsor Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators: Centre Hospitalier Régional Universitaire Montpellier
Conditions
(from sponsor)
Suicide
Related terms Suicide
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov