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Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04230434
Enrollment
58
Registered
2020-01-18
Start date
2019-08-01
Completion date
2020-02-01
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidal Ideation, Suicide, Suicide, Attempted

Keywords

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

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.

Detailed description

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.

Interventions

BEHAVIORALSafety Plan Intervention

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)

Sponsors

Hospital Universitario La Paz
CollaboratorOTHER
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
CollaboratorOTHER
Instituto de Investigación Hospital Universitario La Paz
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Interventional cohort (Safety Plan Intervention)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Suicide attempt or presence of severe suicidal ideation 2. Signed Informed Consent Form

Exclusion criteria

1. Less than 18 years old 2. Hospitalization in the Psychiatry Department 3. Inability to understand the Safety Planning Intervention Withdrawal criteria: 1\) Participant's decision to withdraw from the trial

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Safety Plan ImplementationBaselinePercentage of SPIs performed in ED from total number of suicide related ED visits.

Secondary

MeasureTime frameDescription
Time required for the performance of the SPIBaselineMinutes required for the performance of the SPI
Satisfaction of the patient with the Safety Plant0 (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?
Satisfaction of the Professional with the Safety PlanBaselineLikert-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.
Time to suicide reattemptMonth 6Days from suicide attempt attended in the ED to the next suicide reattempt.
Adherence to psychiatric ambulatory follow-upMonth 6Percentage of patients that attend psychiatric ambulatory follow-up after ED discharge
Presence of suicide reattemptMonth 6Percentage of patients that commit suicide reattempt.

Other

MeasureTime frameDescription
Predictive ability of the clinician in the subsequent conduct suicidal patientBaselineis 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026