Suicide Prevention and Intervention in Spain: the SURVIVE Study

Sponsor

Parc de Salut Mar (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04343703

Collaborator

Instituto de Salud Carlos III (Other)

2,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

200

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Suicide Suicide, Attempted Depression	Behavioral: Telephone-based management Behavioral: iFightDepression for Suicide Behavioral: Treatment as Usual Behavioral: Self Awareness of Mental Health	N/A

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:

To determine the incidence of suicide attempts in Spain
To follow up suicide attempters with the aim of studying the probability of them re-attempting
To identify influential risk factors to explain suicide attempts and an increased risk of re-attempting
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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telephone-based management 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 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. Other Names: TaU
Experimental: iFightDepression for Suicide 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 (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. Other Names: TaU
Active Comparator: 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. TaU will consist of any routine procedures applied at each participating site.	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. Behavioral: 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). Other Names: iFD-S
Experimental: Self Awareness of Mental Health 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 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. Other Names: TaU Behavioral: 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. Other Names: SAM

Outcome Measures

Primary Outcome Measures

Suicide repetition (or death by suicide) [12 months]
The primary outcome is subsequent suicide attempts (and/or suicide mortality) captured across assessment points. Is a binary variable (yes/no).

Secondary Outcome Measures

Brief Symptoms Inventory [1 month]
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.
Patient Health Questionnaire 9-items [2 weeks]
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.
Generalized Anxiety Disorder 7-items [2 weeks]
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.
EuroQol 5D [1 day]
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.
Barrat Impulsivity Scale [2 weeks]
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.
Acquired capability of suicide Scale -Fearlesness about Death [2 weeks]
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).
Reflective Functioning Questionnaire [2 weeks]
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.
Columbia Suicide Rating Scale [1 month]
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.
The International Neuropsychiatric Interview (MINI) [Varies on the diagnosis]
Clinician-rated scale to screen for mental disorders. The MINI KIDs will be used for participants between 12-17 years of age.
Strengths and Difficulties Questionnaire (SDQ) [1 month]
Emotional and behavioral screening questionnaire designed for youths.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Virgen del Rocio	Sevilla	Andalusia	Spain	41013
2	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain	33011
3	Hospital Santiago de Áraba	Vitoria	Basque Country	Spain	01004
4	Hospital Germans Trias i Pujol	Badalona	Catalonia	Spain	08916
5	Institute of Neuropsychiatry and Addictions, INAD, Parc de Salut Mar	Barcelona	Catalonia	Spain	08003
6	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia	Spain	08025
7	Hospital Clinic	Barcelona	Catalonia	Spain	08036
8	Corporació Sanitaria Parc Tauli	Sabadell	Catalonia	Spain	08208
9	Hospital Clínico San Carlos	Madrid		Spain	28040
10	Hospital Universitario La Paz	Madrid		Spain	28046