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Completed

NCT Number: NCT04230434

Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide Prevention Suicide, Attempted

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Paz University Hospital

Madrid, 28029, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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)

Other names: Security Plan

Primary outcomes

  1. Feasibility of Safety Plan Implementation

    Time frame: Baseline

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

Secondary outcomes

  1. Time required for the performance of the SPI

    Time frame: Baseline

    Minutes required for the performance of the SPI

  2. Satisfaction of the patient with the Safety Plan

    Time frame: t0 (Safety Plan Performance )

    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?"

  3. Satisfaction of the Professional with the Safety Plan

    Time frame: Baseline

    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.

  4. Presence of suicide reattempt

    Time frame: Month 6

    Percentage of patients that commit suicide reattempt.

  5. Time to suicide reattempt

    Time frame: Month 6

    Days from suicide attempt attended in the ED to the next suicide reattempt.

  6. Adherence to psychiatric ambulatory follow-up

    Time frame: Month 6

    Percentage of patients that attend psychiatric ambulatory follow-up after ED discharge

Other outcomes

  1. Predictive ability of the clinician in the subsequent conduct suicidal patient

    Time frame: Baseline

    is measured through a dichotomous question in which the professional will make a prognosis about the possibility that the patient may return to commit a suicidal behaviour.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

  • Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
  • Hospital Universitario La Paz

Registry information

Official study title

Safety-Planning Intervention for Suicidal Behavior in an Emergency Department: an Effectiveness-implementation Hybrid Design

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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