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SuicideSURVIVENCT04343703

Suicide Prevention and Intervention in Spain: the SURVIVE Study

A study testing Telephone-based management, iFightDepression for Suicide and Treatment as Usual in people with Suicide and Suicide, Attempted, run by Parc de Salut Mar at 8 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Suicide, Suicide, Attempted, Depression
What is being tested?
Telephone-based management, iFightDepression for Suicide and Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,742 participants
Where
8 sitesSpain
Study dates
1 Jun 2020to 31 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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 locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites
  • Institute of Neuropsychiatry and Addictions, INAD, Parc de Salut Mar

    Barcelona, Catalonia, 08003

  • Hospital Clinic

    Barcelona, Catalonia, 08036

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Corporació Sanitaria Parc Tauli

    Sabadell, Catalonia, 08208

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

  • Hospital Santiago de Áraba

    Vitoria-Gasteiz, Basque Country, 01004

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Telephone-based management, iFightDepression for Suicide, Treatment as Usual, Self Awareness of Mental Health
Keywords
suicide, suicide attempted, depression, secondary prevention, mental health
Medical subject headings
Suicide, Suicide, Attempted, Depression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telephone-based managementBehavioural

    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 SuicideBehavioural

    Also called iFD-S

    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 UsualBehavioural

    Also called TaU

    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 HealthBehavioural

    Also called SAM

    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.

Study groups in NCT04343703
Study groupRoleWhat they receive
Telephone-based managementExperimentalTelephone-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.
Receives: Behavioral: Treatment as Usual
iFightDepression for SuicideExperimentalThe 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.
Receives: Behavioral: Treatment as Usual
Treatment as UsualActive comparatorTreatment 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.
Receives: Behavioral: Telephone-based management; Behavioral: iFightDepression for Suicide
Self Awareness of Mental HealthExperimentalThe 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.
Receives: Behavioral: Treatment as Usual; Behavioral: Self Awareness of Mental Health

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 months

Secondary outcomes (9)
  1. 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.

    Measured: 1 month

  2. 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.

    Measured: 2 weeks

  3. 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.

    Measured: 2 weeks

  4. 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.

    Measured: 1 day

  5. 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.

    Measured: 2 weeks

  6. 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).

    Measured: 2 weeks

  7. 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.

    Measured: 2 weeks

  8. 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.

    Measured: 1 month

  9. Strengths and Difficulties Questionnaire (SDQ)

    Emotional and behavioral screening questionnaire designed for youths.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2020
  2. Study start1 Jun 2020
  3. Primary completion1 Jan 2023
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,742 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04343703
Sponsor's protocol ID
2019/8629/I
Acronym
SURVIVE
Status last verified
Jan 2025
First submitted
8 Apr 2020
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33884617
  • 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.

    PubMed 33301997

Questions about this trial

What is this clinical trial studying?

A study testing Telephone-based management, iFightDepression for Suicide and Treatment as Usual in people with Suicide and Suicide, Attempted, run by Parc de Salut Mar at 8 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suicide repetition (or death by suicide) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04343703, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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