Testing Interventions for Borderline Personality Disorder.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorYork University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

Treatment groups

304 Participants
are divided into 2 treatment groups
Group A: SageExperimental treatment 1 intervention
Group B: SIPActive comparator 1 intervention

Trial outcomes

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.

Time frame
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

1

Conflict Resolution Scale

Self-report measure of relationship conflict. Scores range from 0 to 52, with higher scores reflecting higher levels of conflict resolution.

Time frame
It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
2

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

Self-report measure of depression. Scores range from 0 to 21, with higher scores reflecting higher levels of depression.

Time frame
It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
3

Generalized Anxiety Disorder 7 (GAD-7)

Self-report measure of anxiety. Scores range from 0 to 21, with higher scores reflecting higher levels of anxiety.

Time frame
It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
4

Kessler Psychological Distress Scale-10

Self-report measure of psychological distress. Scores range from 10 to 50, with higher scores reflecting higher levels of psychological distress.

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

Other outcomes

1

Suicide Attempt Self-Injury Interview-modified

Interview measure of frequency of self-injury and suicidal behaviours. Scores reflect the frequency of suicidal and self-injurious behaviour.

Time frame
It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
2

Positive and Negative Affect Schedule (PANAS)- select subscales

Self-report measure of anger, fear, guilt, sadness, fatigue, positive emotion, negative emotion. Score ranges vary across subscales, with higher scores reflecting higher levels of emotion.

Time frame
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.
3

Communication Patterns Questionnaire-23 item version

Self-report measure of communication patterns

Time frame
It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
4

Borderline Symptom List- 23

Self-report measure of BPD severity. Scores range from 0 to 92, with higher scores reflecting higher levels of BPD severity.

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

Sponsors and contacts

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York University

Lead sponsor

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