Smartphone-based Ecological Momentary Intervention for secondary prevention of suicidal thoughts and behaviour: protocol for the SmartCrisis V.2.0 randomised clinical trial
Maria Luisa Barrigon,
Antonio Artes,
Mercedes Perez-Rodriguez,
Philippe Courtet,
Enrique Baca-Garcia,
Sofian Berrouiguet,
Jorge Lopez-Castroman,
Alejandro Porras-Segovia,
María-Mercedes Pérez-Rodríguez,
Antonio Artes-Rodríguez,
Romain Billot,
Juan José Carballo-Belloso,
David Delgado-Gomez,
Marta Migoya-Borja,
Nora Palomar-Ciria,
Alba Sedano-Capdevila,
Sofía Abascal-Peiró,
Susana Amodeo-Escriban,
Ana de Granda,
Rodrigo Carmona,
Elena Gil-Benito,
Laura Mata-Iturralde,
Laura Muñoz-Lorenzo,
Rocío Navarro-Jiménez,
Santiago Ovejero,
Sergio Sánchez-Alonso,
Ezequiel Di Stasio,
José Luis Palomo,
Pedro Martín-Calvo,
Ana José Ortega,
Marta Segura-Valverde,
María Luisa Martin-Calvo,
Raquel Álvarez-García,
Pablo Portillo-de Antonio,
Pablo Puras-Rico,
Eva María Romero-Gómez
Affiliations
Maria Luisa Barrigon
Grupo de Investigación en Psiquiatría Translacional, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Madrid, Spain
Antonio Artes
Departamento de Teoría de Señal, Universidad Carlos III de Madrid, Getafe, Spain
Mercedes Perez-Rodriguez
Philippe Courtet
Department of Emergency Psychiatry and Acute Care, Centre Hospitalier Universitaire Montpellier, University of Montpellier, Montpellier, France
Enrique Baca-Garcia
Department of Psychiatry, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
Sofian Berrouiguet
EA 7479 SPURBO, Université de Bretagne Occidentale, Brest, France
Jorge Lopez-Castroman
Department of Adult Psychiatry, Nîmes University Hospital, Nimes, France
Alejandro Porras-Segovia
Grupo de Investigación en Psiquiatría Translacional, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Madrid, Spain
María-Mercedes Pérez-Rodríguez
Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York, USA
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 V.2.0 randomised 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 V.2.0 study is a randomised clinical trial with two parallel groups, conducted among patients with a history of suicidal behaviour treated at five sites in France and Spain. The intervention group will be monitored using Ecological Momentary Assessment (EMA) and will receive an Ecological Momentary Intervention called ‘SmartSafe’ in addition to their treatment as usual (TAU). TAU will consist of mental health follow-up of the patient (scheduled appointments with a psychiatrist) in an outpatient Suicide Prevention programme, 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, our mobile health intervention and monitoring system can be implemented in routine clinical practice. Results will be disseminated through peer-reviewed journals and psychiatric congresses. Reference number EC005-21_FJD. Participants gave informed consent to participate in the study before taking part.Trial registration number NCT04775160.
