Clinical trial NCT04230434: Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior
Official title: Safety-Planning Intervention for Suicidal Behavior in an Emergency Department: an Effectiveness-implementation Hybrid Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicide, Attempted
Suicidal Ideation
Keywords: Suicide
Suicidal behavior
Suicidal attempt
Suicide prevention
Safety Planning Intervention
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Paz
name: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
First posted: 2020-01-18
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional cohort (Safety Plan Intervention)
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Safety Plan Implementation
timeFrame: Baseline
Secondary outcomes:
measure: Time required for the performance of the SPI
timeFrame: Baseline
measure: Satisfaction of the patient with the Safety Plan
timeFrame: t0 (Safety Plan Performance )
measure: Satisfaction of the Professional with the Safety Plan
timeFrame: Baseline
measure: Presence of suicide reattempt
timeFrame: Month 6
measure: Time to suicide reattempt
timeFrame: Month 6
measure: Adherence to psychiatric ambulatory follow-up
timeFrame: Month 6
Other outcomes:
measure: Predictive ability of the clinician in the subsequent conduct suicidal patient
timeFrame: Baseline
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: Instituto de Investigación Hospital Universitario La Paz
name: Beatriz Rodriguez Vega, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stanley, B., & Brown, G. K. (2012). Safety planning intervention: a brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice, 19(2), 256-264.
citation: Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.