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.
Presenting with a SA or an emergency referral for SI in the past month.
Being able to understand and sign the informed consent form.
Being fluent in Spanish
Owning a smartphone with internet access and iOS or Android operating system.
Refusal to install the mobile application
Inability to understand and sign the informed consent form for any reason.
Institutionalized or incarcerated patients, without access to regular mobile phone use.
Parallel
SmartSafe
DeviceThe 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.
Reduction of suicidal ideation
Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale
Reduction of suicidal ideation
Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale
Acceptability of the mobile health applications
Acceptability of the mobile health applications measured by user satisfaction using satisfaction surveys
Acceptability of the mobile health applications
Acceptability of the mobile health applications measured by user satisfaction using satisfaction surveys
Feasibility of the project: Compliance
Feasibility measured by compliance with EMA questions (% of questions answered)
Feasibility of the project: Compliance
Feasibility measured by compliance with EMA questions (% of questions answered)
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead sponsor
Centre Hospitalier Régional Universitaire Montpellier
Collaborator
