NCT07469917

Brief 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. 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:

  1. 1.Scientifically evaluating the feasibility and effects of SPI in Swedish healthcare.
  2. 2.Developing training programs for healthcare professionals in suicide prevention.
  3. 3.Informing policy decisions and national guidelines.
  4. 4.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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Oct 2025Jul 2029

Study Start

First participant enrolled

October 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

March 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 16, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

prevention of suicidality

Outcome Measures

Primary Outcomes (1)

  • 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.

    Monthly measurements throughout the 45-month study period

Secondary Outcomes (4)

  • Monthly rate of psychiatric inpatient admissions for suicide attempts

    Monthly measurements throughout the 45-month study period

  • Emergency department revisits following suicide attempts

    Monthly measurements throughout the 45-month study period

  • Psychiatric inpatient readmissions following suicide attempts

    Monthly measurements throughout the 45-month study period

  • Incremental cost-effectiveness of SPI implementation

    Assessed over the 45-month implementation period

Study Arms (1)

Safety Planning Intervention for suicide prevention

EXPERIMENTAL

Stepped wedge design with four areas being added to the study on at a time

Behavioral: Safety Planning Intervention (SPI)

Interventions

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.

Safety Planning Intervention for suicide prevention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Region Skåne, psychiatric services

Helsingborg, Skåne County, Sweden

NOT YET RECRUITING

Region Skåne, psychiatric services

Kristianstad, Sweden

NOT YET RECRUITING

Region Skåne, psychiatric services

Lund, Sweden

RECRUITING

Region Skåne, psychiatric services

Malmo, 22736, Sweden

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Central Study Contacts

Sara Lindström, Associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2026

First Posted

March 13, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

March 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations