Suicide Prevention and Intervention in Spain: the SURVIVE Study

Depression Clinical Trial

— SURVIVE  

Official title:

Suicide Prevention and Intervention (SURVIVE): Cohort Study and Nested Randomized Controlled Trials of Secondary Prevention Programs for Suicide Attempts

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04343703
• Other study ID #: 2019/8629/I
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2020
• Source: Parc de Salut Mar
• Contact: Víctor Pérez, PhD
• Phone: 933160784
• Email: vperezsola[@]parcdesalutmar.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: September 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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 5

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.

Related Conditions & MeSH terms

• Depression
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• Telephone-based management
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.
• iFightDepression for Suicide
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).
• Treatment as Usual
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.
• Self Awareness of Mental Health
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.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Catalonia
Spain	Hospital Clinic	Barcelona	Catalonia
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia
Spain	Institute of Neuropsychiatry and Addictions, INAD, Parc de Salut Mar	Barcelona	Catalonia
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Corporació Sanitaria Parc Tauli	Sabadell	Catalonia
Spain	Hospital Universitario Virgen del Rocio	Sevilla	Andalusia
Spain	Hospital Santiago de Áraba	Vitoria	Basque Country

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Brief Symptoms Inventory	The BSI is a 53-item self-report scale designed to evaluate psychopathological and psychological symptoms, measuring nine dimensions (i.e.,somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism) that can be summed up to reflect three global indices. These synthetic indices are the General Severity Index (GSI), the Positive Symptom Distress Index, and the Positive Symptom Total. In more detail, the BSI uses a 5-point Likert scale, ranging from 0 ("not at all") to 4 ("extremely"). Scores range from 0 to 212, higher scores mean a worse outcome.	1 month
Secondary	Patient Health Questionnaire 9-items	The PHQ-9 measures depressive symptoms in a scale from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27 and higher scores mean a worse outcome. The PHQ-9 A will be used for participants aged 12-17.	2 weeks
Secondary	Generalized Anxiety Disorder 7-items	GAD-7 consists of seven items measuring worry and anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity.	2 weeks
Secondary	EuroQol 5D	Part one provides a self-reported description of health problems into five dimensions. Patients have to rate the severity of each dimension in a 5-point scale. For part one, higher scores represent a worse outcome (less quality of life).Part two consist of a Visual Analogue Scale corresponding to the current state of the subject's health. The lowest extreme (0) corresponds to the worst imaginable state, and the highest extreme (100) represents the best imaginable health state.	1 day
Secondary	Barrat Impulsivity Scale	The BIS is a 30-item widely used questionnaire that measures three aspects of impulsivity: 1) motor impulsiveness (acting without forethought), 2) attentional impulsiveness (tendency to make quick, non-reflexive decisions), and 3) non-planned impulsiveness (failure to prepare for future events). Each item is rated in a 4 point scale (0-4). Total scores range from 0 to 44, higher scores represent higher impulsivity.	2 weeks
Secondary	Acquired capability of suicide Scale -Fearlesness about Death	Acquired Capability for Suicide Scale-Fearlessness about Death (ACSS-FAD) is a seven-item self-report measure which uses a 5-point Likert scale ranging from 0 (not at all like me) to 4 (very much like me). Scores range from 0 to 32, and higher scores represent a worse outcome (higher levels of the acquired capability for suicide).	2 weeks
Secondary	Reflective Functioning Questionnaire	The 8-item version of the Reflective Functioning Questionnaire is a self-reported instrument that measures reflective functioning, an expression of mentalizing processes. The instrument separately addresses the levels of both certainty and uncertainty about one's own mental processes. Items are scored in a 7 point-scale (1 to 7), meaning that the total score ranges from 8 to 56, higher scores represent a higher capacity of mentalizing, and therefore a better outcome.	2 weeks
Secondary	Columbia Suicide Rating Scale	The Columbia Suicide Rating Scale is a suicidal ideation and behavior rating scale that evaluates suicide risk.It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors. It contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime and past 3 months. An answer of "yes" to any of the six questions may indicate a need for referral and an answer of "yes" to questions 4, 5 or 6 indicate high-risk.	1 month
Secondary	The International Neuropsychiatric Interview (MINI)	Clinician-rated scale to screen for mental disorders. The MINI KIDs will be used for participants between 12-17 years of age.	Varies on the diagnosis
Secondary	Strengths and Difficulties Questionnaire (SDQ)	Emotional and behavioral screening questionnaire designed for youths.	1 month