Testing Interventions for Borderline Personality Disorder.

NCT06458933 | Recruiting Phase 2 DMC

• 1 other identifier: 495689
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

Borderline personality disorder (BPD) is a life-threatening, costly public health crisis affecting \~1-3% of North Americans, with 10% dying by suicide and annual healthcare costs of \~$63k (Canadian Dollars)/patient. Further, people with BPD's intimate relationships are highly disrupted, and their partners report elevated mental health problems but little access to treatment. Existing BPD treatments are resource-heavy, inaccessible, and 47% of people with BPD do not respond to them. These treatments also neglect relationship problems and intimate partner's mental health concerns, even though they are thought to play a key role in BPD maintenance. BPD interventions may produce stronger, quicker, and more durable outcomes if they incorporated partners to target both the emotional and relationship core of BPD. Moreover, incorporating partners into interventions may improve relationship outcomes and partner mental health without added resource investments. Accordingly, members of our team developed Sage. Named after a plant that thrives in relationship with its ecosystem, Sage is a brief, 12-session conjoint intervention for people with BPD and their intimate partners that targets BPD, relationship conflict, and partner mental health. Our recent uncontrolled trial provides preliminary support for its efficacy. As a next step in testing Sage, it is critical to utilize a Randomized Controlled Trial (RCT) design to identify if Sage is more efficacious than standard care that these couples typically receive; supportive individual psychotherapy (SIP) for people with BPD and their partners. The investigators propose to conduct the first RCT of Sage for couples wherein one member has BPD. The study will examine if Sage is more efficacious than SIP in improving BPD symptoms (primary outcome), as well as relationship conflict and partner mental health (secondary outcomes), as well as a range of other outcomes, from pre- to post-intervention, and post-intervention to follow-up. It will also investigate factors that influence treatment response, BPD severity, and related problems. Up to 152 couples wherein one member has BPD will be randomized to receive Sage or SIP. Gold-standard measures of primary, secondary, and exploratory outcomes will be administered at baseline, mid-intervention, post-intervention, and a one-month, three- month, and six-month follow-up.

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder; Relationship dysfunction; Couple therapy; Emotion dysregulation

Outcome Measures

Primary Outcomes (1)

• Zanarini Rating Scale for BPD (ZAN-BPD)

  Interview measure of BPD severity. Scores range from 0 to 36, with higher scores reflecting higher severity of BPD symptoms.

  It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

Secondary Outcomes (6)

• Conflict Resolution Scale

  It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

• Depression, Anxiety, and Stress Scale- depression subscale (partners)

  It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

• Generalized Anxiety Disorder 7 (GAD-7)

  It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

• Kessler Psychological Distress Scale-10

  It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

• Difficulties in Emotion Regulation Scale (DERS)

  It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

Other Outcomes (46)

• Suicide Attempt Self-Injury Interview-modified

  It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

• Positive and Negative Affect Schedule (PANAS)- select subscales

  It will be administered people with BPD and partners at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and one, three, and six months after the intervention.

• Communication Patterns Questionnaire-23 item version

  It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

Study Arms (2)

Sage

EXPERIMENTAL

Immediately receives 12 sessions of a couple psychotherapy designed to treat borderline personality disorder (BPD) and enhances relationship functioning simultaneously.

Behavioral: Sage

SIP

ACTIVE COMPARATOR

Immediately receives 12 individual sessions each (12 for people with borderline personality disorder (BPD), 12 for partners) of Supportive Individual Psychotherapy (SIP).

Behavioral: Supportive Individual Psychotherapy

Interventions

Sage BEHAVIORAL

Sage is a 12-session manualized weekly intervention delivered to people with borderline personality disorder (BPD) and their intimate partners. The Sage intervention consists of three phases: Phase 1, orientation and safety which focuses on targeting destructive behaviours (e.g., suicide attempts and self harm engagement) by providing couples with safety strategies that target suicide risk/ crisis, education about BPD, the role of emotion dysregulation and intimate relationship dysfunction in maintaining it (\~three sessions). Next, Phase 2, communication and emotion skills entails couples learning communication skills and strategies for identifying, expressing, and regulating emotions (\~five sessions). Lastly, in Phase 3, cognitive skills and intervention termination, couples learn strategies to target negative cognitions that elicit emotion dysregulation and intimate relationship dysfunction (\~four sessions).

Sage

Supportive Individual Psychotherapy BEHAVIORAL

Supportive Individual Psychotherapy (SIP) is a comparator in our control condition reflects enhanced usual care (i.e., supportive psychotherapy) for people with BPD. Both people with BPD and partners will receive SIP sessions separately over the course of 12 sessions, delivered by therapists. For both members of the couple, SIP will involve 12 sessions of a specific form of supportive psychotherapy based on client-centered, humanistic principles. This intervention involves creating a supportive therapeutic relationship, expressing empathy, and helping individuals feel understood. The SIP intervention is designed to support individuals in exploring their relationships and communication patterns as well as following the client's lead on what they want to work on.

SIP

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant with borderline personality disorder (BPD) meets full diagnostic criteria for BPD (i.e., five or more BPD diagnostic criteria per the Diagnostic and Statistical Manual of Mental Disorders-5-TR)
• Both members are at least 19-years-old
• Both members consent to study participation
• Both members consent to a member of the research team contacting one of their provided emergency contacts if there are imminent safety concerns.
• Both members consent to having assessment interviews and treatment sessions audio- and video-recorded
• Both members members reside in Ontario (with no plan to leave the province during the course of the study)
• Both members members are fluent in English
• Both members are willing to receive emails about the study
• Both members have regular internet access from a private location for completion of study appointments

You may not qualify if:

• Severe intimate partner violence in their relationship in the past year (Endorsement of severe intimate partner violence items on Conflict Tactics Scale-2)
• DSM-5 criteria A and B of schizophrenia, not better accounted for by BPD
• Hospitalization in the past year for mania, or mania in the past three months
• A substance/alcohol use disorder that is likely to require medical intervention (e.g., detoxification) to reduce use
• A medical condition that is likely to require hospitalization within the next year
• Scaled score below 70 on the Test of Premorbid Functioning, suggesting impaired intelligence and/or probable traumatic brain injury
• Either participant in the dyad is not able to show proof of identification upon request at any point throughout the study or is not able to provide an accurate phone number or address upon request.
• The individual with BPD is currently receiving an empirically-supported BPD treatment and is unwilling to pause the therapy for the duration of the active treatment phase

Sponsors & Collaborators

• York University: lead
• Centre for Addiction and Mental Health: collaborator
• Toronto Metropolitan University: collaborator
• University of Windsor: collaborator
• Kennesaw State University: collaborator
• University of Winnipeg: collaborator
• The Sashbear Foundation: collaborator

Study Sites (1)

York University

Toronto, California, M3J1P3, Canada

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Central Study Contacts

Skye Fitzpatrick, PhD

CONTACT

461-736-2100; skyefitz@yorku.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 14, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 30, 2030
• Last Updated: April 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Following publication of primary study outcomes

Locations

CA (1)