NCT04779099

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

October 22, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

1.6 years

First QC Date

March 1, 2021

Last Update Submit

December 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

4-session intervention

EXPERIMENTAL
Behavioral: Brief 4-session intervention for borderline personality disorderBehavioral: Treatment as usual

Treatment as usual

ACTIVE COMPARATOR
Behavioral: Treatment as usual

Interventions

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.

4-session intervention

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

4-session interventionTreatment as usual

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • unable to give informed consent;
  • 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
  • IQ \< 70 based on the Wechsler Test of Adult Reading

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 DisorderSuicideSelf-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist and Clinician Scientist

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 3, 2021

Study Start

October 22, 2021

Primary Completion

May 24, 2023

Study Completion

May 24, 2023

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations