Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior

NCT04230434 | Completed

• 1 other identifier: SPI-EI
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Suicide; Suicide, Attempted; Suicidal Ideation

Keywords

Suicide; Suicidal behavior; Suicidal attempt; Suicide prevention; Safety Planning Intervention

Outcome Measures

Primary Outcomes (1)

• Feasibility of Safety Plan Implementation

  Percentage of SPIs performed in ED from total number of suicide related ED visits.

  Baseline

Secondary Outcomes (6)

• Time required for the performance of the SPI

  Baseline

• Satisfaction of the patient with the Safety Plan

  t0 (Safety Plan Performance )

• Satisfaction of the Professional with the Safety Plan

  Baseline

• Presence of suicide reattempt

  Month 6

• Time to suicide reattempt

  Month 6

Other Outcomes (1)

• Predictive ability of the clinician in the subsequent conduct suicidal patient

  Baseline

Study Arms (1)

Safety Plan Intervention

EXPERIMENTAL

The Safety Plan Intervention (SPI) performed in ED or in ambulatory appointment

Behavioral: Safety Plan Intervention

Interventions

Safety Plan Intervention BEHAVIORAL

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)

Also known as: Security Plan

Safety Plan Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suicide attempt or presence of severe suicidal ideation
• Signed Informed Consent Form

You may not qualify if:

• Less than 18 years old
• Hospitalization in the Psychiatry Department
• Inability to understand the Safety Planning Intervention
• Withdrawal criteria:
• \) Participant's decision to withdraw from the trial

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Hospital Universitario La Paz: collaborator
• Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz: collaborator

Study Sites (1)

La Paz University Hospital

Madrid, Madrid, 28029, Spain

Location

MeSH Terms

Conditions

Suicide; Suicide, Attempted; Suicidal Ideation; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Beatriz Rodriguez Vega, PhD

  Instituto de Investigación Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional cohort (Safety Plan Intervention)

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: January 18, 2020
• Study Start: August 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available one year after publishing the final results for at least 5 years
• Access Criteria: Please contact PI Beatriz Rodríguez-Vega (beatrizrvega@gmail.com)

Locations

ES (1)