Back to resultsTrial of a Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department
Primary Purpose
Borderline Personality Disorder, Suicide and Self-harm
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brief 4-session intervention for borderline personality disorder
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder
Eligibility Criteria
Inclusion Criteria:
- aged 16 or older
- presenting to ED with self-harm and/or suicidal ideation; and
- meeting criteria for BPD on the Structured Clinical Interview for DSM-5 Personality Disorders
Exclusion Criteria:
- unable to give informed consent;
- meeting DSM-5 criteria for severe substance use disorder, schizophrenia spectrum disorder or bipolar disorder I mania based on the Structured Clinical Interview for DSM-5 (28); and/or
- IQ < 70 based on the Wechsler Test of Adult Reading
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
4-session intervention
Treatment as usual
Arm Description
Outcomes
Primary Outcome Measures
Primary clinical outcome measure - Emergency Department Visits
The primary clinical outcome will be the mean group difference in frequency of ER visits on the Client Service Receipt Inventory (CSRI)
Secondary Outcome Measures
Full Information
NCT ID
NCT04779099
First Posted
March 1, 2021
Last Updated
May 8, 2023
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT04779099
Brief Title
Trial of a Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department
Official Title
Pilot Randomized Controlled Trial of a Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
May 24, 2023 (Anticipated)
Study Completion Date
May 24, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
When in crisis, people with borderline personality disorder (BPD) frequently seek care in emergency departments (EDs) often presenting with suicide and self-harm behaviour. There is no established evidence-based brief intervention for patients with BPD in ED settings, however a 4-session psychotherapeutic intervention for people with personality disorders in ED settings was tested in Australia and showed promising results in reduced health care utilization. The proposed pilot randomized controlled trial will assess the feasibility of delivering this 4-session intervention in the ED for people with BPD who present with suicidal ideation or self-harm with the aim of reducing health care utilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Suicide and Self-harm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
4-session intervention
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Brief 4-session intervention for borderline personality disorder
Intervention Description
Intervention consists of weekly 50-minute 1:1 sessions focused on psycho-education, here-and-now problem solving and safety planning. One of the sessions can involve a significant other to provide psychoeducation about the disorder and to facilitate support. This intervention is detailed in a published manual.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
TAU comprises access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.
Primary Outcome Measure Information:
Title
Primary clinical outcome measure - Emergency Department Visits
Description
The primary clinical outcome will be the mean group difference in frequency of ER visits on the Client Service Receipt Inventory (CSRI)
Time Frame
1, 3 and 6 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 16 or older
presenting to ED with self-harm and/or suicidal ideation; and
meeting criteria for BPD on the Structured Clinical Interview for DSM-5 Personality Disorders
Exclusion Criteria:
unable to give informed consent;
meeting DSM-5 criteria for severe substance use disorder, schizophrenia spectrum disorder or bipolar disorder I mania based on the Structured Clinical Interview for DSM-5 (28); and/or
IQ < 70 based on the Wechsler Test of Adult Reading
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J1H4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Trial of a Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department
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