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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04779099
Other study ID # 2020-796
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 22, 2021
Est. completion date May 24, 2023

Study information

Verified date May 2023
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date May 24, 2023
Est. primary completion date May 24, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Study Design


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.
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.

Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary clinical outcome measure - Emergency Department Visits The primary clinical outcome will be the mean group difference in frequency of ER visits on the Client Service Receipt Inventory (CSRI) 1, 3 and 6 month follow up
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