Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT04343703
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2020-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Suicide Prevention and Intervention in Spain: the SURVIVE Study
Sponsor:
Parc de Salut Mar
Organization:
Study Overview
Official Title:
Suicide Prevention and Intervention (SURVIVE): Cohort Study and Nested Randomized Controlled Trials of Secondary Prevention Programs for Suicide Attempts
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SURVIVE
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: