NCT06675461

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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Dec 2024Aug 2027

First Submitted

Initial submission to the registry

November 4, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 12, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.6 years

First QC Date

November 4, 2024

Last Update Submit

February 9, 2026

Conditions

Keywords

Brief InterventionBrief TreatmentTreatmentInterventionGold Card

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 Month Follow Up

Secondary Outcomes (8)

  • Suicidal Ideation

    3 Month Follow Up

  • Health Care Use

    3 and 6 Month Follow Up

  • Borderline Personality Disorder Symptoms

    3 and 6 Month Follow Up

  • Self-Harm Behavior

    3 and 6 Month Follow Up

  • Emotion Regulation

    3 and 6 Month Follow Up

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Gold Card Intervention

Interventions

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.

Gold Card Intervention

Access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.

Treatment As Usual

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Statistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Scientist

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 5, 2024

Study Start

December 12, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations