SuicideNCT04230434
Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior
A study testing Safety Plan Intervention in people with Suicide and Suicide, Attempted, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The Safety Plan Intervention (SPI) has demonstrated to reduce suicide reattempts and to increase the ambulatory follow-up in american war veterans. This study evaluates the implementability and effectiveness in a significantly different population in a real world setting. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Suicide, Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Safety Plan Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2019to 1 Feb 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suicide attempt or presence of severe suicidal ideation
- Signed Informed Consent Form
Who cannot join
- Less than 18 years old
- Hospitalization in the Psychiatry Department
- Inability to understand the Safety Planning Intervention
- Withdrawal criteria:
- 1) Participant's decision to withdraw from the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety-Planning Intervention for Suicidal Behavior in an Emergency Department: an Effectiveness-implementation Hybrid Design
The Safety Plan Intervention (SPI) has demonstrated to reduce suicide reattempts and to increase the ambulatory follow-up in american war veterans. This study evaluates the implementability and effectiveness in a significantly different population in a real world setting.
Read the detailed description
We will perform a Effectiveness-implementation Hybrid Design (Curran et al. 2012) to study firstly the feasibility of implementing the SPI in our clinical setting and secondly its effectiveness. The experimental arm will consist in a group of patients who visit the ED for a suicide-related concern in which the SPI is performed. This will be in the Emergency Department , unless for clinical reasons, the ED psychiatrist decide to postpone it to the first psychiatric appointment (which will be before one week of the ED visit as part of the treatment as usual).
Right after the SPI is performed, both the patient and the clinician will complete questionnaire with satisfaction and acceptability measures. Subjects will be followed for 6 months. At this time medical records will be consulted to obtain suicide reattempts rates and follow-up adherence.
At all times, the anonymity of the participants will be preserved and will require heading of informed consent, as well as other ethical aspects indicated by the Ethics Committee.
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation
- Being tested
- Safety Plan Intervention
- Keywords
- Suicide, Suicidal behavior, Suicidal attempt, Suicide prevention, Safety Planning Intervention
- Medical subject headings
- Suicide, Suicide, Attempted, Suicidal Ideation, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Plan InterventionBehavioural
Also called Security Plan
The SPI has 6 key steps: (1) identify personalized warning signs for an impending suicide crisis; (2) determine internal coping strategies that distract from suicidal thoughts and urges; (3) identify family and friends who are able to distract from suicidal thoughts and urges and social places that provide the opportunity for interaction; (4) identify individuals who can help provide support during a suicidal crisis; (5) list mental health professionals and urgent care services to contact during a suicidal crisis; and (6) lethal means counseling for making the environment safer (Stanley \& Brown, 2012)
| Study group | Role | What they receive |
|---|---|---|
| Safety Plan Intervention | Experimental | The Safety Plan Intervention (SPI) performed in ED or in ambulatory appointment Receives: Behavioral: Safety Plan Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Safety Plan Implementation
Percentage of SPIs performed in ED from total number of suicide related ED visits.
Measured: Baseline
Secondary outcomes (6)
Time required for the performance of the SPI
Minutes required for the performance of the SPI
Measured: Baseline
Satisfaction of the patient with the Safety Plan
Likert-type scales with 5 levels of response will be measured through questions: "To what extent do the Safety Plan can help you to avoid a new situation of suicidal risk?"
Measured: t0 (Safety Plan Performance )
Satisfaction of the Professional with the Safety Plan
Likert-type with 5 levels of response will be measured through questions: "To what extent do the Safety Plan can help you to avoid a new situation of suicidal risk?" Likert-type with 5 levels of response will be measured through questions: "To what extent the Safety Plan did you useful for the patient?". Open questions can be explained where contributions and obstacles encountered in its implementation will also be formulated.
Measured: Baseline
Presence of suicide reattempt
Percentage of patients that commit suicide reattempt.
Measured: Month 6
Time to suicide reattempt
Days from suicide attempt attended in the ED to the next suicide reattempt.
Measured: Month 6
Adherence to psychiatric ambulatory follow-up
Percentage of patients that attend psychiatric ambulatory follow-up after ED discharge
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Aug 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional cohort (Safety Plan Intervention)
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Responsible party
- Sponsor
- Investigators
- Beatriz Rodriguez Vega, PhD, Principal investigator, Instituto de Investigación Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230434
- Sponsor's protocol ID
- SPI-EI
- Status last verified
- Sep 2025
- First submitted
- 29 Nov 2019
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with other researchers on request
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety-Planning Intervention for Suicidal Behavior in an Emergency Department: an Effectiveness-implementation Hybrid Design
- ClinicalTrials.gov ID
- NCT04230434
- Acronym / sponsor ID
- SPI-EI
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation
- Keywords
- Suicide, Suicidal behavior, Suicidal attempt, Suicide prevention, Safety Planning Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Safety Plan Intervention (SPI) has demonstrated to reduce suicide reattempts and to increase the ambulatory follow-up in american war veterans. This study evaluates the implementability and effectiveness in a significantly different population in a real world setting.
Detailed description
We will perform a Effectiveness-implementation Hybrid Design (Curran et al. 2012) to study firstly the feasibility of implementing the SPI in our clinical setting and secondly its effectiveness. The experimental arm will consist in a group of patients who visit the ED for a suicide-related concern in which the SPI is performed. This will be in the Emergency Department , unless for clinical reasons, the ED psychiatrist decide to postpone it to the first psychiatric appointment (which will be before one week of the ED visit as part of the treatment as usual).
Right after the SPI is performed, both the patient and the clinician will complete questionnaire with satisfaction and acceptability measures. Subjects will be followed for 6 months. At this time medical records will be consulted to obtain suicide reattempts rates and follow-up adherence.
At all times, the anonymity of the participants will be preserved and will require heading of informed consent, as well as other ethical aspects indicated by the Ethics Committee.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional cohort (Safety Plan Intervention)
| Arm | Type | Receives |
|---|---|---|
| Safety Plan Intervention | Experimental | Behavioral: Safety Plan InterventionThe Safety Plan Intervention (SPI) performed in ED or in ambulatory appointment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suicide attempt or presence of severe suicidal ideation
- Signed Informed Consent Form
Key exclusion criteria (5 listed)
- Less than 18 years old
- Hospitalization in the Psychiatry Department
- Inability to understand the Safety Planning Intervention
- 1) Participant's decision to withdraw from the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety Plan InterventionAlso: Security PlanThe SPI has 6 key steps: (1) identify personalized warning signs for an impending suicide crisis; (2) determine internal coping strategies that distract from suicidal thoughts and urges; (3) identify family and friends who are able to distract from suicidal thoughts and urges and social places that provide the opportunity for interaction; (4) identify individuals who can help provide support during a suicidal crisis; (5) list mental health professionals and urgent care services to contact during a suicidal crisis; and (6) lethal means counseling for making the environment safer (Stanley \& Brown, 2012) | Behavioural | Safety Plan Intervention |
Primary outcome
Feasibility of Safety Plan Implementation
Time frame: Baseline
Percentage of SPIs performed in ED from total number of suicide related ED visits.
6 secondary outcomes
Time required for the performance of the SPI
Time frame: Baseline
Satisfaction of the patient with the Safety Plan
Time frame: t0 (Safety Plan Performance )
Satisfaction of the Professional with the Safety Plan
Time frame: Baseline
Presence of suicide reattempt
Time frame: Month 6
Time to suicide reattempt
Time frame: Month 6
Adherence to psychiatric ambulatory follow-up
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Yes. Data will be shared with other researchers on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Rodriguez Vega, PhD principal investigator
Instituto de Investigación Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Plan Intervention in people with Suicide and Suicide, Attempted, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Feasibility of Safety Plan Implementation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2025.