Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior
Primary Purpose
Suicide, Suicide, Attempted, Suicidal Ideation
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Safety Plan Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Suicide focused on measuring Suicide, Suicidal behavior, Suicidal attempt, Suicide prevention, Safety Planning Intervention
Eligibility Criteria
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:
1) Participant's decision to withdraw from the trial
Sites / Locations
- La Paz University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Safety Plan Intervention
Arm Description
The Safety Plan Intervention (SPI) performed in ED or in ambulatory appointment
Outcomes
Primary Outcome Measures
Feasibility of Safety Plan Implementation
Percentage of SPIs performed in ED from total number of suicide related ED visits.
Secondary Outcome Measures
Time required for the performance of the SPI
Minutes required for the performance of the SPI
Satisfaction of the patient with the Safety Plan
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 Plan
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
Percentage of patients that commit suicide reattempt.
Time to suicide reattempt
Days from suicide attempt attended in the ED to the next suicide reattempt.
Adherence to psychiatric ambulatory follow-up
Percentage of patients that attend psychiatric ambulatory follow-up after ED discharge
Full Information
NCT ID
NCT04230434
First Posted
November 29, 2019
Last Updated
January 12, 2022
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Hospital Universitario La Paz, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
1. Study Identification
Unique Protocol Identification Number
NCT04230434
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Hospital Universitario La Paz, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicide, Attempted, Suicidal Ideation
Keywords
Suicide, Suicidal behavior, Suicidal attempt, Suicide prevention, Safety Planning Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional cohort (Safety Plan Intervention)
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Safety Plan Intervention
Arm Type
Experimental
Arm Description
The Safety Plan Intervention (SPI) performed in ED or in ambulatory appointment
Intervention Type
Behavioral
Intervention Name(s)
Safety Plan Intervention
Other Intervention Name(s)
Security Plan
Intervention Description
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)
Primary Outcome Measure Information:
Title
Feasibility of Safety Plan Implementation
Description
Percentage of SPIs performed in ED from total number of suicide related ED visits.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Time required for the performance of the SPI
Description
Minutes required for the performance of the SPI
Time Frame
Baseline
Title
Satisfaction of the patient with the Safety Plan
Description
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 Frame
t0 (Safety Plan Performance )
Title
Satisfaction of the Professional with the Safety Plan
Description
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.
Time Frame
Baseline
Title
Presence of suicide reattempt
Description
Percentage of patients that commit suicide reattempt.
Time Frame
Month 6
Title
Time to suicide reattempt
Description
Days from suicide attempt attended in the ED to the next suicide reattempt.
Time Frame
Month 6
Title
Adherence to psychiatric ambulatory follow-up
Description
Percentage of patients that attend psychiatric ambulatory follow-up after ED discharge
Time Frame
Month 6
Other Pre-specified Outcome Measures:
Title
Predictive ability of the clinician in the subsequent conduct suicidal patient
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
1) Participant's decision to withdraw from the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Rodriguez Vega, PhD
Organizational Affiliation
Instituto de Investigación Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Paz University Hospital
City
Madrid
ZIP/Postal Code
28029
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with other researchers on request
IPD Sharing Time Frame
Data will be available one year after publishing the final results for at least 5 years
IPD Sharing Access Criteria
Please contact PI Beatriz Rodríguez-Vega (beatrizrvega@gmail.com)
Citations:
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.
Results Reference
background
PubMed Identifier
22310560
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.
Results Reference
result
Learn more about this trial
Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior
We'll reach out to this number within 24 hrs