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Enrolling by Invitation

NCT Number: NCT06675461

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.

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Key information

Conditions

Borderline Personality Disorder (BPD) Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Gold Card Intervention

Behavioral

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 Usual

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2024
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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