Suicide Prevention and Intervention (SURVIVE): Cohort Study and Nested Randomized Controlled Trials of Secondary Prevention Programs for Suicide Attempts
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Suicide
- Sponsor
- Parc de Salut Mar
- Enrollment
- 1742
- Locations
- 8
- Primary Endpoint
- Suicide repetition (or death by suicide)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Víctor Pérez
Medical Director
Parc de Salut Mar
Eligibility Criteria
Inclusion Criteria
- •Female and males, age \>= 12 years
- •Having attended a hospital emergency department due to a suicide attempt
- •Willing and able to comply with study procedures and to give written informed consent
- •Specific inclusion criteria for iFD-S:
- •Minimum knowledge of internet use and availability of an internet device (tablet, computer, smartphone)
- •Depressive symptoms according to PHQ-9 scores above 15
- •Specific inclusion criteria for SAM:
- •Age between 12-17
- •Informed consent of legal guardians
Exclusion Criteria
- •Incapacity to give informed consent
- •Lack of fluency in Spanish
- •Currently taking part in another clinical study which, in the opinion of the investigator, is likely to interfere with the objectives of the SURVIVE study.
Outcomes
Primary Outcomes
Suicide repetition (or death by suicide)
Time Frame: 12 months
The primary outcome is subsequent suicide attempts (and/or suicide mortality) captured across assessment points. Is a binary variable (yes/no).
Secondary Outcomes
- Brief Symptoms Inventory(1 month)
- Patient Health Questionnaire 9-items(2 weeks)
- Generalized Anxiety Disorder 7-items(2 weeks)
- Barrat Impulsivity Scale(2 weeks)
- EuroQol 5D(1 day)
- Acquired capability of suicide Scale -Fearlesness about Death(2 weeks)
- Reflective Functioning Questionnaire(2 weeks)
- Columbia Suicide Rating Scale(1 month)
- Strengths and Difficulties Questionnaire (SDQ)(1 month)