Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior

Not Applicable

Completed

• Conditions: Suicide; Suicide, Attempted; Suicidal Ideation
• Interventions: Behavioral: Safety Plan Intervention

• Registration Number: NCT04230434
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-11-29
• Primary Completion: 2020-01-01
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Study Completion: 2020-02-01
• Status Verified: 2021-07
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Feasibility of Safety Plan Implementation	Baseline	Percentage of SPIs performed in ED from total number of suicide related ED visits.

Secondary Outcome Measures

Name	Time	Method
Satisfaction of the patient with the Safety Plan	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?"
Time required for the performance of the SPI	Baseline	Minutes required for the performance of the SPI
Satisfaction of the Professional with the Safety Plan	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.
Presence of suicide reattempt	Month 6	Percentage of patients that commit suicide reattempt.
Time to suicide reattempt	Month 6	Days from suicide attempt attended in the ED to the next suicide reattempt.
Adherence to psychiatric ambulatory follow-up	Month 6	Percentage of patients that attend psychiatric ambulatory follow-up after ED discharge

Trial Locations

Locations (1)

La Paz University Hospital; 🇪🇸 Madrid, Spain