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

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ClinicalTrials.gov Identifier: NCT04779099
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Anne Sonley, Centre for Addiction and Mental Health

Study Description
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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 intervention for patients with BPD in ED settings, however a 4-session psychotherapeutic intervention for people with personality disorders in ED settings was tested in Australia and showed promising results in reduced health care utilization. The proposed pilot randomized controlled trial will assess the feasibility 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 health care utilization.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Suicide and Self-harm Behavioral: Brief 4-session intervention for borderline personality disorder Behavioral: Treatment as usual Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Randomized Controlled Trial of a Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 4-session intervention Behavioral: Brief 4-session intervention for borderline personality disorder
Intervention consists of weekly 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. This intervention is detailed in a published manual.

Behavioral: Treatment as usual
TAU comprises access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.
Active Comparator: Treatment as usual Behavioral: Treatment as usual
TAU comprises access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.


Outcome Measures
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Primary Outcome Measures :
  1. Primary clinical outcome measure - Emergency Department Visits [ Time Frame: 1, 3 and 6 month follow up ]
    The primary clinical outcome will be the mean group difference in frequency of ER visits on the Client Service Receipt Inventory (CSRI)


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged 16 or older
  2. presenting to ED with self-harm and/or suicidal ideation; and
  3. meeting criteria for BPD on the Structured Clinical Interview for DSM-5 Personality Disorders

Exclusion Criteria:

  1. unable to give informed consent;
  2. meeting DSM-5 criteria for severe substance use disorder, schizophrenia spectrum disorder or bipolar disorder I mania based on the Structured Clinical Interview for DSM-5 (28); and/or
  3. IQ < 70 based on the Wechsler Test of Adult Reading
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779099


Contacts
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Contact: Anne Sonley, MD 416-535-8501 ext 37242 anne.sonley@camh.ca

Sponsors and Collaborators
Centre for Addiction and Mental Health
More Information
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Responsible Party: Anne Sonley, Psychiatrist and Clinician Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04779099    
Other Study ID Numbers: 2020-796
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Suicide
Personality Disorders
Borderline Personality Disorder
Self-Injurious Behavior
 Pathologic Processes
Disease Attributes
Behavioral Symptoms
Mental Disorders