- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04779099
Trial of a Brief Psychological Intervention for Suicidal Patients with Borderline Personality Disorder in the Emergency Department
December 2, 2024 updated by: Anne Sonley, Centre for Addiction and Mental Health
Pilot Randomized Controlled Trial of a Brief Psychological Intervention for Suicidal Patients with Borderline Personality Disorder in the Emergency Department
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M6J1H4
- Centre for Addiction and Mental Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment as usual
|
TAU comprises access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.
|
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Experimental: 4-session intervention
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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.
TAU comprises access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary clinical outcome measure - Emergency Department Visits
Time Frame: 1, 3 and 6 month follow up
|
The primary clinical outcome will be the mean group difference in frequency of ER visits on the Client Service Receipt Inventory (CSRI)
|
1, 3 and 6 month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 22, 2021
Primary Completion (Actual)
May 24, 2023
Study Completion (Actual)
May 24, 2023
Study Registration Dates
First Submitted
March 1, 2021
First Submitted That Met QC Criteria
March 2, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
December 4, 2024
Last Update Submitted That Met QC Criteria
December 2, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-796
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Borderline Personality Disorder
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University of California, Los AngelesRecruitingBorderline Personality Disorder | Borderline Personality | BPD - Borderline Personality DisorderUnited States
-
University Hospital, Basel, SwitzerlandLeading House for the Latin American Region (Seed Money Grant SMG 1730)WithdrawnBorderline Personality Disorder (BPD)
-
Waypoint Centre for Mental Health CareRecruitingBorderline Personality Disorder (BPD)Canada
-
Mclean HospitalNot yet recruitingBorderline Personality Disorder (BPD)United States
-
University Hospital, MontpellierNot yet recruitingBorderline Personality Disorder | Borderline Personality Disorder (BPD)
-
Health Service Executive, IrelandCompletedPersonality Disorder, Borderline
-
University Hospital, ToulouseNot yet recruitingBorderline Personality Disorder (BPD) | Infusion of Ketamine in Severe Borderline Personality DisorderFrance
-
IRCCS Centro San Giovanni di Dio FatebenefratelliCompletedBorderline Personality Disorder (BPD)Italy
-
University of EdinburghCompletedEmotionally Unstable Personality Disorder, Borderline TypeUnited Kingdom
-
Hospital Universitari Vall d'Hebron Research InstituteUnknownBorderline Personality Disorder.Spain
Clinical Trials on Brief 4-session intervention for borderline personality disorder
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University Hospital, Basel, SwitzerlandLeading House for the Latin American Region (Seed Money Grant SMG 1730)WithdrawnBorderline Personality Disorder (BPD)
-
Freie Universität BerlinRuhr University of Bochum; University of BremenRecruitingBorderline Personality Disorder | MothersGermany
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University of British ColumbiaCompletedLow Female Sexual Arousal | Low Female Sexual DesireCanada
-
University Hospital, ToulouseNot yet recruitingBorderline Personality Disorder (BPD) | Infusion of Ketamine in Severe Borderline Personality DisorderFrance
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University of Ljubljana, Faculty of MedicineUniversity Medical Centre Ljubljana; University Maribor; University Psychiatric...RecruitingNon-Suicidal Self Injury | Self-harm | Personality Disorder, Borderline | Difference, Individual | Epigenetic Disorder | Change; MentalSlovenia
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Radboud University Medical CenterBill and Melinda Gates FoundationCompleted