- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07469917
Safety Planning Intervention in Swedish Healthcare: A Multisite Study for Suicide Prevention
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara Lindström, Associate professor
- Phone Number: +46702823770
- Email: sara.lindstrom@med.lu.se
Study Locations
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Kristianstad, Sweden
- Not yet recruiting
- Region Skåne, psychiatric services
-
Contact:
- Sara Lindström
- Phone Number: 0702823770
- Email: sara.lindstrom@med.lu.se
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Contact:
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Principal Investigator:
- Sara Lindström
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Lund, Sweden
- Recruiting
- Region Skåne, psychiatric services
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Contact:
- Sara Lindström
- Phone Number: 0702823770
- Email: sara.lindstrom@med.lu.se
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Principal Investigator:
- Sara Lindström
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Malmo, Sweden, 22736
- Recruiting
- Region Skåne, psychiatric services
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Contact:
- Sara Lindström, Associate professor
- Phone Number: 0702823770
- Email: sara.lindstrom@med.lu.se
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Skåne County
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Helsingborg, Skåne County, Sweden
- Not yet recruiting
- Region Skåne, psychiatric services
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Contact:
- Sara Lindström
- Phone Number: 0702823770
- Email: sara.lindstrom@med.lu.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
Age under 18 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Safety Planning Intervention for suicide prevention
Stepped wedge design with four areas being added to the study on at a time
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Monthly rate of emergency visits for suicide attempts
Time Frame: Monthly measurements throughout the 45-month study period
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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.
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Monthly measurements throughout the 45-month study period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Monthly rate of psychiatric inpatient admissions for suicide attempts
Time Frame: Monthly measurements throughout the 45-month study period
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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.
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Monthly measurements throughout the 45-month study period
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Emergency department revisits following suicide attempts
Time Frame: Monthly measurements throughout the 45-month study period
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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.
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Monthly measurements throughout the 45-month study period
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Psychiatric inpatient readmissions following suicide attempts
Time Frame: Monthly measurements throughout the 45-month study period
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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.
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Monthly measurements throughout the 45-month study period
|
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Incremental cost-effectiveness of SPI implementation
Time Frame: Assessed over the 45-month implementation period
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Incremental cost-effectiveness ratio comparing the Safety Planning Intervention (SPI) with usual care based on healthcare utilization costs and suicide-related healthcare events.
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Assessed over the 45-month implementation period
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Nuij C, van Ballegooijen W, de Beurs D, Juniar D, Erlangsen A, Portzky G, et al. Safety planning-type interventions for suicide prevention: meta-analysis. The British journal of psychiatry : the journal of mental science. 2021;219(2):419-26
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-00323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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VA Office of Research and DevelopmentCompletedSuicideUnited States
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