Suicide AttemptNCT07469917
Safety Planning Intervention in Swedish Healthcare: A Multisite Study for Suicide Prevention
A study testing Safety Planning Intervention (SPI) in people with Suicide Attempt, run by Region Skane at 4 sites in Sweden.
Trial summary
Suicide is one of the leading causes of premature death and a prioritized public health concern. Safety Planning Intervention (SPI) is a method with strong international research support for reducing suicidal behaviour by enhancing individuals' strategies for crisis management and improving access to support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Attempt
- What is being tested?
- Safety Planning Intervention (SPI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 4 sitesSweden
- Study dates
- 1 Oct 2025to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting to psychiatric services with suicidal ideation, suicidal planning, or a suicide attempt
- Patients receiving care in participating adult psychiatric emergency or inpatient units
Who cannot join
- Age under 18 years
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Not yet recruiting
Region Skåne, psychiatric services
Helsingborg, Skåne County
Sara Lindström, 0702823770, sara.lindstrom@med.lu.se
- Not yet recruiting
Region Skåne, psychiatric services
Kristianstad
Sara Lindström, 0702823770, sara.lindstrom@med.lu.se
sara.probert-lindstrom@med.lu.se
- Recruiting
Region Skåne, psychiatric services
Lund
Sara Lindström, 0702823770, sara.lindstrom@med.lu.se
Sara Lindström
- Recruiting
Region Skåne, psychiatric services
Malmö, 22736
Sara Lindström, Associate professor, 0702823770, sara.lindstrom@med.lu.se
About this study
Suicide is one of the leading causes of premature death and a prioritized public health concern.
Safety Planning Intervention (SPI) is a method with strong international research support for reducing suicidal behaviour by enhancing individuals' strategies for crisis management and improving access to support. SPI is a single-session intervention lasting approximately 45 minutes, which any healthcare provider can deliver after a brief training. Despite promising results, the implementation of SPI in Swedish healthcare remains limited. This project examines how SPI can be integrated into various healthcare settings and evaluates its impact on suicide-related emergency visits, psychiatric hospitalizations, and healthcare utilization. Data and Methods Stepped-Wedge implementation study in specialist psychiatry, where SPI is gradually introduced in psychiatric units. This study design allows for a robust evaluation of effects while ensuring all units eventually receive the intervention. As part of this study, a survey among healthcare professionals will be conducted to assess their experiences with feasibility, usability, and implementation barriers.
Read more
Data will be collected from QlikView healthcare utilization data. Poisson regression models with mixed effects will be used to analyze the impact of SPI on emergency visits and psychiatric hospitalizations. A health economic analysis will be conducted to evaluate the cost-effectiveness of SPI. Societal Relevance and Impact
The project contributes to Sweden's national suicide prevention strategy by:
- Scientifically evaluating the feasibility and effects of SPI in Swedish healthcare.
- Developing training programs for healthcare professionals in suicide prevention.
- Informing policy decisions and national guidelines.
- Analyzing the cost-effectiveness of SPI from a societal perspective. Implementation The research team includes experts in suicide prevention, psychiatry, epidemiology, patient safety, and health economics, creating a strong multidisciplinary foundation. The Stepped-Wedge design ensures an ethically and methodologically sound evaluation of SPI.
Gradual implementation allows for time-based comparisons, minimizes selection bias, and ensures all patients receive the intervention. The project is conducted in close collaboration with healthcare providers and policymakers to ensure that research findings can be integrated into clinical practice and strengthen suicide prevention efforts in Sweden.
- Conditions
- Suicide Attempt
- Being tested
- Safety Planning Intervention (SPI)
- Keywords
- prevention of suicidality
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Planning Intervention (SPI)Behavioural
Safety Planning Intervention (SPI), developed by Stanley \& Brown (12), is a brief, structured suicide preventive intervention designed to help individuals identify warning signs, develop coping strategies, and establish emergency contact pathways. SPI is a single-session intervention that typically lasts approximately 45 minutes and is delivered in clinical or emergency care settings. It is designed to help individuals identify warning signs, develop coping strategies, and establish a concrete plan for seeking support during a suicidal crisis. Unlike traditional risk assessments that focus on predicting suicide risk, SPI actively engages individuals in managing crises before they escalate. The intervention consists of six core steps.
| Study group | Role | What they receive |
|---|---|---|
| Safety Planning Intervention for suicide prevention | Experimental | Stepped wedge design with four areas being added to the study on at a time Receives: Behavioral: Safety Planning Intervention (SPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly rate of emergency visits for suicide attempts
Monthly number of emergency department visits for suicide attempts identified using ICD-10 codes X60-X84 and events of undetermined intent (Y10-Y34), obtained from aggregated healthcare utilization data from psychiatric clinics in Region Skåne.
Measured: Monthly measurements throughout the 45-month study period
Secondary outcomes (4)
Monthly rate of psychiatric inpatient admissions for suicide attempts
Monthly number of psychiatric inpatient admissions with ICD-10 diagnoses indicating suicide attempts (X60-X84) or events of undetermined intent (Y10-Y34), obtained from aggregated healthcare utilization data.
Measured: Monthly measurements throughout the 45-month study period
Emergency department revisits following suicide attempts
Monthly number of emergency department revisits due to suicide attempts or events of undetermined intent within 30 days, 6 months, or 12 months after a previous visit.
Measured: Monthly measurements throughout the 45-month study period
Psychiatric inpatient readmissions following suicide attempts
Monthly number of psychiatric inpatient readmissions due to suicide attempts or events of undetermined intent within 30 days, 6 months, or 12 months after a previous admission.
Measured: Monthly measurements throughout the 45-month study period
Incremental cost-effectiveness of SPI implementation
Incremental cost-effectiveness ratio comparing the Safety Planning Intervention (SPI) with usual care based on healthcare utilization costs and suicide-related healthcare events.
Measured: Assessed over the 45-month implementation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide AttemptStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Forte
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469917
- Sponsor's protocol ID
- 2025-00323
- Other IDs
- 2025
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nuij C, van Ballegooijen W, de Beurs D, Juniar D, Erlangsen A, Portzky G, O'Connor RC, Smit JH, Kerkhof A, Riper H. Safety planning-type interventions for suicide prevention: meta-analysis. Br J Psychiatry. 2021 Aug;219(2):419-426. doi: 10.1192/bjp.2021.50.
PubMed 35048835
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Planning Intervention in Swedish Healthcare: A Multisite Study for Suicide Prevention
- ClinicalTrials.gov ID
- NCT07469917
- Acronym / sponsor ID
- 2025-00323
- Conditions
- Suicide Attempt
- Keywords
- prevention of suicidality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Forte
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 13 Mar 2026 (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.
Suicide is one of the leading causes of premature death and a prioritized public health concern.
Safety Planning Intervention (SPI) is a method with strong international research support for reducing suicidal behaviour by enhancing individuals' strategies for crisis management and improving access to support. SPI is a single-session intervention lasting approximately 45 minutes, which any healthcare provider can deliver after a brief training. Despite promising results, the implementation of SPI in Swedish healthcare remains limited. This project examines how SPI can be integrated into various healthcare settings and evaluates its impact on suicide-related emergency visits, psychiatric hospitalizations, and healthcare utilization. Data and Methods Stepped-Wedge implementation study in specialist psychiatry, where SPI is gradually introduced in psychiatric units. This study design allows for a robust evaluation of effects while ensuring all units eventually receive the intervention. As part of this study, a survey among healthcare professionals will be conducted to assess their experiences with feasibility, usability, and implementation barriers.
Data will be collected from QlikView healthcare utilization data. Poisson regression models with mixed effects will be used to analyze the impact of SPI on emergency visits and psychiatric hospitalizations. A health economic analysis will be conducted to evaluate the cost-effectiveness of SPI. Societal Relevance and Impact
The project contributes to Sweden's national suicide prevention strategy by:
- Scientifically evaluating the feasibility and effects of SPI in Swedish healthcare.
- Developing training programs for healthcare professionals in suicide prevention.
- Informing policy decisions and national guidelines.
- Analyzing the cost-effectiveness of SPI from a societal perspective. Implementation The research team includes experts in suicide prevention, psychiatry, epidemiology, patient safety, and health economics, creating a strong multidisciplinary foundation. The Stepped-Wedge design ensures an ethically and methodologically sound evaluation of SPI.
Gradual implementation allows for time-based comparisons, minimizes selection bias, and ensures all patients receive the intervention. The project is conducted in close collaboration with healthcare providers and policymakers to ensure that research findings can be integrated into clinical practice and strengthen suicide prevention efforts in Sweden.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety Planning Intervention for suicide prevention | Experimental | Behavioral: Safety Planning Intervention (SPI)Stepped wedge design with four areas being added to the study on at a time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting to psychiatric services with suicidal ideation, suicidal planning, or a suicide attempt
- Patients receiving care in participating adult psychiatric emergency or inpatient units
Key exclusion criteria (1 listed)
- Age under 18 years
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 Planning Intervention (SPI)Safety Planning Intervention (SPI), developed by Stanley \& Brown (12), is a brief, structured suicide preventive intervention designed to help individuals identify warning signs, develop coping strategies, and establish emergency contact pathways. SPI is a single-session intervention that typically lasts approximately 45 minutes and is delivered in clinical or emergency care settings. It is designed to help individuals identify warning signs, develop coping strategies, and establish a concrete plan for seeking support during a suicidal crisis. Unlike traditional risk assessments that focus on predicting suicide risk, SPI actively engages individuals in managing crises before they escalate. The intervention consists of six core steps. | Behavioural | Safety Planning Intervention for suicide prevention |
Primary outcome
Monthly rate of emergency visits for suicide attempts
Time frame: Monthly measurements throughout the 45-month study period
Monthly number of emergency department visits for suicide attempts identified using ICD-10 codes X60-X84 and events of undetermined intent (Y10-Y34), obtained from aggregated healthcare utilization data from psychiatric clinics in Region Skåne.
4 secondary outcomes
Monthly rate of psychiatric inpatient admissions for suicide attempts
Time frame: Monthly measurements throughout the 45-month study period
Emergency department revisits following suicide attempts
Time frame: Monthly measurements throughout the 45-month study period
Psychiatric inpatient readmissions following suicide attempts
Time frame: Monthly measurements throughout the 45-month study period
Incremental cost-effectiveness of SPI implementation
Time frame: Assessed over the 45-month implementation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 35048835Nuij C, van Ballegooijen W, de Beurs D, Juniar D, Erlangsen A, Portzky G, O'Connor RC, Smit JH, Kerkhof A, Riper H. Safety planning-type interventions for suicide prevention: meta-analysis. Br J Psychiatry. 2021 Aug;219(2):419-426. doi: 10.1192/bjp.2021.50.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Planning Intervention (SPI) in people with Suicide Attempt, run by Region Skane at 4 sites in Sweden.
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 1 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Lindström, Associate professor (+46702823770, sara.lindstrom@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly rate of emergency visits for suicide attempts (time frame: Monthly measurements throughout the 45-month study period). 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 NCT07469917, which also lists 1 linked publication.
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 13 Mar 2026.