Borderline Personality Disorder (BPD)NCT06675461
Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department
A study testing Gold Card Intervention and Treatment as usual in people with Borderline Personality Disorder (BPD), run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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 treatment for patients with BPD in ED settings, however a 4-session treatment for people with… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Borderline Personality Disorder (BPD)
- What is being tested?
- Gold Card Intervention and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Borderline Personality Disorder (BPD)
- Being tested
- Gold Card Intervention, Treatment as usual
- Keywords
- Brief Intervention, Brief Treatment, Treatment, Intervention, Gold Card
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold Card InterventionBehavioural
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.
Treatment as usualBehavioural
Access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | Active comparator | Access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care. Receives: Behavioral: Treatment as usual |
| Gold Card Intervention | Experimental | 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. Receives: Behavioral: Gold Card Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Ideation
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.
Measured: 6 Month Follow Up
Secondary outcomes (8)
Suicidal Ideation
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.
Measured: 3 Month Follow Up
Health Care Use
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.
Measured: 3 and 6 Month Follow Up
Borderline Personality Disorder Symptoms
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.
Measured: 3 and 6 Month Follow Up
Self-Harm Behavior
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.
Measured: 3 and 6 Month Follow Up
Emotion Regulation
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.
Measured: 3 and 6 Month Follow Up
Depressive Symptoms
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.
Measured: 3 and 6 Month Follow Up
Functioning
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.
Measured: 3 and 6 Month Follow Up
Quality of Life
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.
Measured: 3 and 6 Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start12 Dec 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder (BPD)Studies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Sonley, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675461
- Sponsor's protocol ID
- 2022-081
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department
- ClinicalTrials.gov ID
- NCT06675461
- Acronym / sponsor ID
- 2022-081
- Conditions
- Borderline Personality Disorder (BPD)
- Keywords
- Brief Intervention, Brief Treatment, Treatment, Intervention, Gold Card
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | Active comparator | Behavioral: Treatment as usualAccess to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care. |
| Gold Card Intervention | Experimental | Behavioral: Gold Card InterventionA 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gold Card InterventionA 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. | Behavioural | Gold Card Intervention |
| Treatment as usualAccess to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care. | Behavioural | Treatment As Usual |
Primary outcome
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.
8 secondary outcomes
Suicidal Ideation
Time frame: 3 Month Follow Up
Health Care Use
Time frame: 3 and 6 Month Follow Up
Borderline Personality Disorder Symptoms
Time frame: 3 and 6 Month Follow Up
Self-Harm Behavior
Time frame: 3 and 6 Month Follow Up
Emotion Regulation
Time frame: 3 and 6 Month Follow Up
Depressive Symptoms
Time frame: 3 and 6 Month Follow Up
Functioning
Time frame: 3 and 6 Month Follow Up
Quality of Life
Time frame: 3 and 6 Month Follow Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Borderline Personality Disorder (BPD)
Recruiting
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
Borderline Personality Disorder (BPD)
Not yet recruitingPhase 2
Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
Infusion of Ketamine in Severe Borderline Personality Disorder, Borderline Personality Disorder (BPD)
Recruiting
Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
Borderline Personality Disorder (BPD)
Recruiting
Effectiveness of Enhanced Dialectical Behavior Therapy Skills Training Group for Borderline Personality Disorder
Borderline Personality Disorder (BPD), Dialectical Behavior Therapy
RecruitingObservational study
Long Term Follow-up of Mentalization-Based Treatment: Exploring Variability in Outcomes, Long-term Value and Experiences 10+ Year After Receiving MBT Day Hospital or MBT Intensive Outpatient
Borderline Personality Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gold Card Intervention and Treatment as usual in people with Borderline Personality Disorder (BPD), run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal Ideation (time frame: 6 Month Follow Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.