The Suicide Prevention and Intervention Study (SURVIVE): Study protocol for a multisite cohort study with nested randomized-controlled trials

Introduction: Suicide is one of the leading causes of avoidable death. Gathering national data on suicidal behaviour incidence is crucial to develop evidence-based public policies. The study has two primary objectives: (1) to determine the incidence of suicide attempts in Spain and related risk factors, and (2) to analyze the efficacy of secondary prevention programmes to prevent suicide re-attempting in comparison to treatment as usual (TAU). Materials and methods: Multisite, coordinated, cohort study with three nested randomized controlled trials. A cohort of 2000 individuals (age >=12) with suicidal behaviour will be recruited at ten sites distributed across Spain. Assessments will be conducted within 10 days of the suicide attempt (V0-baseline visit) and after 12 months (V4-last visit) and will include clinician reported and participant reported outcomes (PROs). Between V0 and V4, PROs will be collected remotely every three months (V1, V2 and V3). Optatively, cohort participants will participate in three nested randomized-controlled-trials (RCTs) evaluating different secondary prevention interventions: Participants aged 18 years and older will be randomly allocated to: Telephone-based Management + TAU vs. TAU or iFightDepression-Survive + TAU vs. TAU. Participants aged between 12 and 18 years will be allocated to a specific intervention for youths: Self Awareness of Mental Health + TAU vs. TAU. Results: This study will provide interesting data to estimate suicide attempt incidence in Spain. and will provide evidence on three. Conclusions: Evidence on three potentially efficacious interventions for individuals at high risk of suicide will be obtained, and this could improve the treatment given to these individuals. Trial registration: NCT04343703 (c) 2020 Sociedad Espanola de Psiquiatria y Salud Mental (SEPSM). Published by Elsevier Espana, S.L.U. All rights reserved.