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Enrolling by invitation NCT06675461

Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department

No phase Interventional Borderline Personality Disorder (BPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gold Card Intervention, Treatment as usual.
Who it may be relevant to
Registry conditions: Borderline Personality Disorder (BPD). Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Randomized Controlled Trial of a Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department

Overview

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.

Interventions

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

Primary outcome measures

  • Suicidal Ideation [Time frame: 6 Month Follow Up]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre for Addiction and Mental Health — Toronto

Identifiers

NCT: NCT06675461 · 2022-081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗