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NCT Number: NCT06458933

Testing Interventions for Borderline Personality Disorder.

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.

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

York University

Toronto, California, M3J1P3, Canada

Location status: Recruiting

Location contact

Skye Fitzpatrick, PhD

CONTACT

[email protected]

Skye Fitzpatrick, PhD

PRINCIPAL_INVESTIGATOR

Vinushini Arunagiri, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

EXCLUSION:

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Zanarini Rating Scale for BPD (ZAN-BPD)

    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.

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

Secondary outcomes

  1. Conflict Resolution Scale

    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.

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

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

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

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

  3. Generalized Anxiety Disorder 7 (GAD-7)

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

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

  4. Kessler Psychological Distress Scale-10

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

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

  5. Difficulties in Emotion Regulation Scale (DERS)

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

    Self-report measure of emotion dysregulation. Scores range from 36 to 180, with higher scores reflecting higher levels of emotion dysregulation.

  6. Addiction Severity Index

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

    Self-report measure of problematic alcohol or substance use. Scores vary across substances and items, but higher scores indicate higher levels of problematic substance use.

Other outcomes

  1. Suicide Attempt Self-Injury Interview-modified

    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.

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

  2. Positive and Negative Affect Schedule (PANAS)- select subscales

    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.

    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.

  3. Communication Patterns Questionnaire-23 item version

    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.

    Self-report measure of communication patterns

  4. Borderline Symptom List- 23

    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.

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

  5. Borderline Symptom List- 23-INFORMANT REPORT

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

    Informant-report measure of BPD severity Scores range from 0 to 92, with higher scores reflecting higher levels of partner's BPD severity.

  6. Humor Styles Questionnaire - affiliative subscale

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

    Self-report measure of humour and positive communication qualities. Scores range from 8 to 56, with higher scores reflecting higher levels of humour.

  7. Perceived Relationship Quality Component

    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.

    Self-report measure of relationship satisfaction. Score ranges vary across subscales, with higher scores reflecting higher relationship quality.

  8. Couples Satisfaction Inventory- 16 item version

    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.

    Self-report measure of relationship satisfaction. Scores range from 0 to 81, with higher scores reflecting higher levels of relationship satisfaction.

  9. Sage skills use measure

    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.

    Use of Sage skills self-report measure, created for present study. Scores range from 0 to 60, with higher scores reflecting higher levels of Sage skill use.

  10. Sage skills use measure (in session)

    Time frame: It will be administered to people with BPD and partners in the Sage condition at the beginning of every session.

    Use of Sage skills self-report measure, created for present study. Scores reflect the number of times a skill was used.

  11. Feinberg Brief Co-Parenting Scale

    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.

    Self-report measure of co-parenting experiences. Scores range from 0 to 72, with higher scores reflecting higher levels positive co-parenting.

  12. Empathic accuracy measure

    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.

    Self and informant-report measure of one's own and one's partner's emotions. Scores for each emotion range from 1 to 5, with higher scores indicating higher levels of emotion.

  13. Working Alliance Inventory- Short form

    Time frame: It will be administered to people with BPD and partners, as well as their therapists, approximately weekly from weeks one to 12.

    Self-report measure of working therapeutic alliance. Scores range from 12 to 60, with higher scores reflecting a stronger therapeutic alliance.

  14. Posttraumatic Checklist-5 (PCL-5)

    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.

    Self-report measure of PTSD symptoms. Scores range from 0 to 80, with higher scores reflecting higher levels of PTSD severity.

  15. Informant Difficulties in Emotion Regulation Scale (DERS)

    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.

    Informant-report measure of emotion dysregulation. Scores range from 8 to 40, with higher scores reflecting higher levels of informant-reported emotion dysregulation.

  16. Depression, Anxiety, and Stress Scale- depression subscale (people with BPD)

    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.

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

  17. Generalized Anxiety Disorder 7 (GAD-7)

    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.

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

  18. Difficulties in Emotion Regulation Scale (DERS)

    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.

    Self-report measure of emotion dysregulation. Scores range from 36 to 180, with higher scores reflecting higher levels of emotion dysregulation.

  19. Experiences of Shame Scale

    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.

    Self-report measure of shame. Scores range from 25 to 100, with higher scores reflecting higher levels of shame.

  20. Impulsive Behaviour Scale

    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.

    Self-report measure of impulsive behaviour. Scores range from 25 to 125, with higher scores reflecting higher frequency of impulsive behaviour.

  21. Self Compassion Scale-Short form

    Time frame: It will be administered people with BPD at baseline (pre-intervention), 12 weeks, and 36 weeks.

    Self-report measure of self-compassion Scores range from 12 to 60, with higher scores reflecting higher levels of self-compassion.

  22. Multidimensional scale of perceived social support

    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.

    Self-report measure of perceived social support. Scores range from 1 to 7, with higher scores reflecting higher levels of perceived social support.

  23. Sexual functioning and satisfaction items

    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.

    Singular items measuring sexual functioning and satisfaction. Higher scores generally reflect higher sexual satisfaction or frequency of sexual activity.

  24. Break up items

    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.

    Singular items measuring whether the relationship has ended.

  25. Conflict tactics scale-2: Negotiation subscale

    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.

    Self-report measure of negotiation communication. Scores range from 0 to 36, with higher scores reflecting higher levels negotiation communication.

  26. Subjective emptiness scale

    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.

    Self-report measure of emptiness. Higher scores reflect higher emptiness.

  27. Inventory of Interpersonal Problems (IIP)- BPD subscale

    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.

    Self-report measure of interpersonal problems in BPD. Scores range from 0 to 72, with higher scores reflecting higher levels of interpersonal problems.

  28. Addiction Severity Index

    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.

    Self-report measure of problematic alcohol or substance use. Scores vary across substances and items, but higher scores indicate higher levels of problematic substance use.

  29. Kessler Psychological Distress Scale-10

    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.

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

  30. Brief Inventory of Psychosocial Functioning

    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.

    Self-report measure of social functioning. Scores range from 0 to 44, with higher scores reflecting more difficulties in social functioning.

  31. Short Form (12) Health Survey

    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.

    Self-report measure of health

  32. Barratt Impulsiveness Scale-11

    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.

    Self-report measure of impulsivity

  33. Columbia Suicide Severity Rating Scale- Suicidal Ideation section

    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.

    Interview measure of suicidal ideation. The presence and intensity of suicidal ideation are scored separately and range from 0 to 5 and 0 to 25, respectively, with higher scores reflecting higher severity.

  34. Dissociative Experiences Scale II

    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.

    Self-report measure of dissociation. Higher scores reflect higher levels of dissociation.

  35. Mental Health Utilization

    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.

    Qualitative interview of measure of mental health service utilization.

  36. Emergency Department Visits

    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.

    Interview of measure of frequency of emergency department visits and reasons for them.

  37. World Health Organization Quality of Life Items

    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.

    Three items measuring health, physical functioning, quality of life. Scores range from 1 to 5, with higher scores reflecting higher perceived health, work functioning or quality of life.

  38. Revised University of California-Los Angeles Loneliness Scale

    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.

    Self-report measure of loneliness Scores range from 20 to 80, with higher scores reflecting higher levels of loneliness.

  39. Emotion Regulation Questionnaire

    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.

    Measure of suppression and reappraisal emotion regulation strategy use. Scores range from 4 to 28 for suppression, and 6 to 42 for reappraisal, with higher scores reflecting higher emotion regulation strategy use.

  40. Relationship Questionnaire

    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-item measure of attachment. Each attachment style is rated on a scale from 1 to 7, with higher scores reflecting a higher measure of each attachment style.

  41. Mentalization Scale

    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.

    Self-report measure of mentalization. Scores range from 28 to 140.

  42. Interpersonal Needs Questionnaire

    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.

    Self-report measure of perceived burdensomeness and thwarted belongingness. Higher scores reflect higher levels of perceived burdensomeness and thwarted belongingness.

  43. Test of Roles and Reactions in Dyads (TORRID)

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

    Self-report measure of roles partners of people with BPD play and their experiences in their relationship. Scores range depending on subscale, with higher scores reflecting higher identification with the role in question.

  44. Burden assessment scale

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

    Self-report measure of burden. Score ranges vary across subscales, with higher scores reflecting higher levels of burden.

  45. The Satisfaction With Therapy and Therapist Scale-Revised (STTS-R)

    Time frame: It will be administered to people with BPD and partners at immediately after the intervention (12 weeks).

    Self-report measure of satisfaction with intervention and therapist. Scores range from 12 to 60, with higher scores reflecting higher levels of satisfaction with intervention and therapist.

  46. Behavioural communication sample

    Time frame: It will be administered to people with BPD and their partners in the Sage condition only at the first and last intervention session.

    A videorecording of the couple discussing a problem in their relationship. The sample is then coded using a reliable and valid coding system for adaptive and maladaptive communication behaviours.

Study contacts

Contact information is provided by the study sponsor or research team.

Skye Fitzpatrick, PhD

CONTACT

[email protected]

461-736-2100 ext. 66214

Sponsors and collaborators

Lead sponsor

York University

Other

Collaborators

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

Registry information

Official study title

A Randomized Controlled Trial Testing Sage: A Couple Intervention for Borderline Personality Disorder

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jun 14, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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