Suicide Prevention and Intervention in Spain: the SURVIVE Study

NCT04343703 | Completed

• 1 other identifier: 2019/8629/I
• Study Type: interventional
• Target: 1,742
• Locations: 1 country
• Sites: 8

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.

Conditions

Suicide; Suicide, Attempted; Depression

Keywords

suicide; suicide attempted; depression; secondary prevention; mental health

Outcome Measures

Primary Outcomes (1)

• Suicide repetition (or death by suicide)

  The primary outcome is subsequent suicide attempts (and/or suicide mortality) captured across assessment points. Is a binary variable (yes/no).

  12 months

Secondary Outcomes (9)

• Brief Symptoms Inventory

  1 month

• Patient Health Questionnaire 9-items

  2 weeks

• Generalized Anxiety Disorder 7-items

  2 weeks

• EuroQol 5D

  1 day

• Barrat Impulsivity Scale

  2 weeks

Study Arms (4)

Telephone-based management

EXPERIMENTAL

Telephone-based management will consist of a three-phase intervention: 1) An initial 15-20 min call at 1 week of enrollment in which the cases manager introduces him/herself, and does a short assessment of the current suicide risk, 2) A 5-10 min telephone follow-up at 1, 3, 6, 9 and 12 months, 3) If suicide risk is detected, a 15-45 min crisis intervention call will be done, tailored to the participant's characteristics and context. If deemed necessary, an emergency face-to-face appointment will be scheduled. At each phone call information regarding the current treatment, adherence to mental health services, and current life stressors will be collected.

Behavioral: Treatment as Usual

iFightDepression for Suicide

EXPERIMENTAL

The iFightDepression-Survive (iFD-S) program 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 iFD 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. To that end, the expertise of a panel of mental health experts in suicide and cognitive-behavioral interventions will be asked. The iFD-S also provides telephone guidance (2h per participant) during the use of the program.

Behavioral: Treatment as Usual

Treatment as Usual

ACTIVE COMPARATOR

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. TaU will consist of any routine procedures applied at each participating site.

Behavioral: Telephone-based management; Behavioral: iFightDepression for Suicide

Self Awareness of Mental Health

EXPERIMENTAL

The Self Awareness of Mental Health (SAM) is an adaptation of the Youth Awareness of Mental Health program, originally developed for the Saving and Empowering Young Lives in Europe (SEYLE) study. The SAM aims to raise mental health awareness about risk and protective factors associated with suicide, provide knowledge about depression and anxiety, and enhance the skills needed to cope with adverse life events and suicidal behavior. The intervention is delivered by trained clinical psychologists in five, 45-60 minutes, face-to-face sessions.

Behavioral: Treatment as Usual; Behavioral: Self Awareness of Mental Health

Interventions

Telephone-based management BEHAVIORAL

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.

Treatment as Usual

iFightDepression for Suicide BEHAVIORAL

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).

Also known as: iFD-S

Treatment as Usual

Treatment as Usual BEHAVIORAL

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.

Also known as: TaU

Self Awareness of Mental Health; Telephone-based management; iFightDepression for Suicide

Self Awareness of Mental Health BEHAVIORAL

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.

Also known as: SAM

Self Awareness of Mental Health

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Minimum knowledge of internet use and availability of an internet device (tablet, computer, smartphone)
• Depressive symptoms according to PHQ-9 scores above 15
• Age between 12-17
• Informed consent of legal guardians

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (8)

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

Location

Hospital Santiago de Áraba

Vitoria-Gasteiz, Basque Country, 01004, Spain

Location

Institute of Neuropsychiatry and Addictions, INAD, Parc de Salut Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

Location

Corporació Sanitaria Parc Tauli

Sabadell, Catalonia, 08208, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (2)

• 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.

  PMID: 33884617 DERIVED

• 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.

  PMID: 33301997 DERIVED

MeSH Terms

Conditions

Suicide; Suicide, Attempted; Depression; Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Víctor Pérez, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: June 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: March 31, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)