NCT04343703

Suicide Prevention and Intervention in Spain: the SURVIVE Study

Suicide Prevention and Intervention (SURVIVE): Cohort Study and Nested Randomized Controlled Trials of Secondary Prevention Programs for Suicide Attempts

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,742 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Suicide is one of the leading causes of avoidable death worldwide. Gathering population-representative data on the incidence of suicidal behavior, as well as developing effective secondary prevention strategies are imperative parts of evidence-based public health policies, currently lacking in Spain. The Suicide Prevention and Intervention Study (SURVIVE) is a multi-site-cohort study with nested randomized-controlled clinical trials. The principal aims of the SURVIVE study are to determine the incidence of suicide attempts in Spain and to investigate the efficacy of two secondary prevention programs.

Detailed description

Suicide is the leading cause of avoidable death worldwide, demanding urgent attention. Collecting national-representative data is the first step towards developing effective evidence-based public-policies. The SURVIVE study presents four inter-connected objectives: 1. To determine the incidence of suicide attempts in Spain 2. To follow up suicide attempters with the aim of studying the probability of them re-attempting 3. To identify influential risk factors to explain suicide attempts and an increased risk of re-attempting 4. To determine the efficacy of secondary prevention programs to prevent suicide re-attempts in comparison to treatment as usual (TAU). Study design: Multi-site-coordinated cohort study with nested randomized controlled trials. Participants will be recruited at mental-health sites distributed across Spain. Participants: A cohort of 2.000 individuals presenting a suicide attempt will be established. Individuals would be followed for 1-year, and assessed every 3 months. Participants (age \>18) that meet inclusion/exclusion criteria will be randomly allocated to: 1\) telephone-based management, or 2) iFightDepression for Suicide (iFD-Survive), a web-based-self-management tool. These interventions will be tested against TAU. Participants (age between 12-17) that meet inclusion/exclusion criteria will be randomly allocated to: 1)a face-to-face individual intervention designed for youths Specific Aware of Mental Health Intervention for adolescents (SAM) or 2) TAU.

Conditions

• Suicide
• Suicide, Attempted
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Telephone-based management	The intervention consists of a series of phone calls aimed at providing follow up care of individuals at risk. At each phone call the case manager collects information regarding the current treatment, adherence to mental health services, and current life stressors.
BEHAVIORAL	iFightDepression for Suicide	The iFD-Survive is a cognitive-behavioral, internet-based self-management tool, developed by the European Alliance Against Depression (EAAD). The iFD is intended to address mild-to-moderate depressive symptoms. The iDF tool is structured in seven core modules focused on: behavioral activation, cognitive restructuring, sleep regulation, mood monitoring, and healthy lifestyle habits. The content of each module is intended to be followed over 1 week and consists of written information, tasks to do over the week and worksheets. All of these aims to consolidate learning and promote self-monitoring. For this study, an additional module (iFD-S) will be developed. The iFD-S also provides telephone guidance (2h per participant).
BEHAVIORAL	Treatment as Usual	Treatment as Usual (TaU) will vary across sites, however it generally implies a combination of case management strategies (including telephone calls, visits by mental health services) and pharmacotherapy. For this study, any nonspecific intervention to address suicidal behavior or to prevent suicide will be considered as treatment as usual.
BEHAVIORAL	Self Awareness of Mental Health	The SAM consist of five, face-to-face, individual sessions designed to raise awareness about depression, anxiety and suicidal behaviors as well as to enhancing skills to effectively cope with stressful life events and mood.

Timeline

• Start date: 2020-06-01
• Primary completion: 2023-01-01
• Completion: 2024-03-31
• First posted: 2020-04-13
• Last updated: 2025-01-07

Locations

8 sites across 1 country: Spain