- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06675461
Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department
February 9, 2026 updated by: Anne Sonley, Centre for Addiction and Mental Health
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 treatment for patients with BPD in ED settings, however a 4-session treatment for people with personality disorders in ED settings was tested in Australia and showed promising results in reducing health care use and improving symptoms.
A recent pilot feasibility randomized controlled trial (RCT) comparing this 4-session treatment to treatment as usual was conducted at the Centre for Addiction and Mental Health and preliminary findings have shown that the treatment is feasible to deliver and acceptable to both patients and clinicians.
The proposed fully powered RCT will build on this pilot data to assess the efficacy 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 emergency health care use and improving BPD symptoms, functioning and quality of life.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
180
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
-
-
Ontario
-
Toronto, Ontario, Canada, M6J1H4
- Centre for Addiction and Mental Health
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures;
- Aged 16 or older;
- Presenting to ED with self-harm and/or suicidal ideation;
- Meeting criteria for BPD on the International Personality Disorders Examination (IPDE).
- Endorsing a score of 1 or greater on the Suicide Ideation Attributes Scale (SIDAS).
Exclusion Criteria:
- Meeting DSM-5 criteria for schizophrenia spectrum disorder or bipolar disorder I mania based on the Structured Clinical Interview for DSM-5 (SCID-5);
- Severe alcohol or substance use disorder based on the Structured Clinical Interview for DSM-5 (SCID-5) requiring medical detoxification or residential treatment.
- IQ < 70 based on the Test of Premorbid Functioning (TOPF).
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment As Usual
Access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.
|
Access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.
|
|
Experimental: Gold Card Intervention
A 4-session manualized intervention consisting of weekly scheduled 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.
|
A 4-session manualized intervention consisting of weekly scheduled 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidal Ideation
Time Frame: 6 Month Follow Up
|
Suicidal Ideation Attributes Scale (SIDAS): is a self-report questionnaire that assesses history and severity of suicidal behaviour and ideation.
Scores range from 0-50 with lower scores indicating less suicidal ideation.
|
6 Month Follow Up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidal Ideation
Time Frame: 3 Month Follow Up
|
Suicidal Ideation Attributes Scale (SIDAS): is a self-report questionnaire that assesses history and severity of suicidal behaviour and ideation.
Scores range from 0-50 with lower scores indicating less suicidal ideation.
|
3 Month Follow Up
|
|
Health Care Use
Time Frame: 3 and 6 Month Follow Up
|
Client Service Receipt Inventory (CSRI): is a brief self-report questionnaire assessing the frequency of patient contact with health, social care or other professionals, as well as emergency departments visits and hospital admissions.
|
3 and 6 Month Follow Up
|
|
Borderline Personality Disorder Symptoms
Time Frame: 3 and 6 Month Follow Up
|
Borderline Symptom Checklist-23 (BSL-23): is a self report questionnaire that assesses BPD symptoms during the previous week.
The 23-item questionnaire has patients rate their experience of symptoms on a 5-point scale from 0 (not at all) to 4 (very strong).
Total score is an average with a minimum of 0 and a maximum of 4. Higher scores indicate more BPD symptoms.
|
3 and 6 Month Follow Up
|
|
Self-Harm Behavior
Time Frame: 3 and 6 Month Follow Up
|
Deliberate Self-Harm Inventory (DSHI): is a 17-item self-report questionnaire measuring frequency, severity, duration, and type of self-harm, which is defined as the direct destruction of body tissue.
|
3 and 6 Month Follow Up
|
|
Emotion Regulation
Time Frame: 3 and 6 Month Follow Up
|
Difficulties in Emotion Regulation Scale (DERS): ) is a self-report questionnaire that measures six facets of emotion regulation.
Scores range from 0-180 with higher scores indicating more emotional dysregulation.
|
3 and 6 Month Follow Up
|
|
Depressive Symptoms
Time Frame: 3 and 6 Month Follow Up
|
Patient Health Questionnaire-9 (PHQ-9): is a 9-item self-report questionnaire assessing depression severity.
Scores range from 0-27 with higher scores indicating more severe depression.
|
3 and 6 Month Follow Up
|
|
Functioning
Time Frame: 3 and 6 Month Follow Up
|
WHO Disability Assessment Schedule (WHODAS): is a self-report questionnaire measuring health and disability across all diseases, including mental, neurological and addictive disorders.
It assesses functioning in cognition, mobility, self-care, getting along, life activities and participation.
Total score can range from 0-100 with 100 indicating full disability.
|
3 and 6 Month Follow Up
|
|
Quality of Life
Time Frame: 3 and 6 Month Follow Up
|
WHO Quality of Life (WHOQOL): is a brief self-report questionnaire assessing quality of life in domains of physical and psychological health, interpersonal relationships and environment.
Scores range from 0-100 with 100 indicating the best possible state of health.
|
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)
December 12, 2024
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Study Registration Dates
First Submitted
November 4, 2024
First Submitted That Met QC Criteria
November 4, 2024
First Posted (Actual)
November 5, 2024
Study Record Updates
Last Update Posted (Actual)
February 11, 2026
Last Update Submitted That Met QC Criteria
February 9, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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-
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