Suicide Prevention and Intervention in Spain: the SURVIVE Study

Parc de Salut Mar

Status: Completed

Conditions: Suicide, Attempted; Depression; Suicide

Treatments: Behavioral: iFightDepression for Suicide; Behavioral: Telephone-based management; Behavioral: Treatment as Usual; Behavioral: Self Awareness of Mental Health

Study type: Interventional

Funder types: Other

Identifiers

NCT04343703

2019/8629/I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,742 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,742 participants in 4 patient groups

Telephone-based management

Experimental group

Description:

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.

Treatment:

Behavioral: Treatment as Usual

iFightDepression for Suicide

Experimental group

Description:

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.

Treatment:

Behavioral: Treatment as Usual

Treatment as Usual

Active Comparator group

Description:

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.

Treatment:

Behavioral: Telephone-based management

Behavioral: iFightDepression for Suicide

Self Awareness of Mental Health

Experimental group

Description:

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.

Treatment:

Behavioral: Self Awareness of Mental Health

Behavioral: Treatment as Usual