Clinical trial NCT04343703: Suicide Prevention and Intervention in Spain: the SURVIVE Study
Official title: Suicide Prevention and Intervention (SURVIVE): Cohort Study and Nested Randomized Controlled Trials of Secondary Prevention Programs for Suicide Attempts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicide, Attempted
Depression
Keywords: suicide
suicide attempted
depression
secondary prevention
mental health
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2020-04-13
Enrollment: 1742
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: General 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

General 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.

Primary outcomes:
measure: Suicide repetition (or death by suicide)
timeFrame: 12 months
Secondary outcomes:
measure: Brief Symptoms Inventory
timeFrame: 1 month
measure: Patient Health Questionnaire 9-items
timeFrame: 2 weeks
measure: Generalized Anxiety Disorder 7-items
timeFrame: 2 weeks
measure: EuroQol 5D
timeFrame: 1 day
measure: Barrat Impulsivity Scale
timeFrame: 2 weeks
measure: Acquired capability of suicide Scale -Fearlesness about Death
timeFrame: 2 weeks
measure: Reflective Functioning Questionnaire
timeFrame: 2 weeks
measure: Columbia Suicide Rating Scale
timeFrame: 1 month
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 1 month
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalusia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Vitoria
country: Spain
facility: Hospital Santiago de Áraba
state: Basque Country
city: Barcelona
country: Spain
facility: Institute of Neuropsychiatry and Addictions, INAD, Parc de Salut Mar
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Catalonia
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Tauli
state: Catalonia
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Parc de Salut Mar
name: Víctor Pérez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
citation: Perez V, Elices M, Toll A, Bobes J, Lopez-Sola C, Diaz-Marsa M, Grande I, Lopez-Pena P, Rodriguez-Vega B, Ruiz-Veguilla M, de la Torre-Luque A; SURVIVE Group. The Suicide Prevention and Intervention Study (SURVIVE): Study protocol for a multisite cohort study with nested randomized-controlled trials. Span J Psychiatry Ment Health. 2023 Jan-Mar;16(1):16-23. doi: 10.1016/j.rpsm.2020.11.004. Epub 2020 Dec 7.