Sage: A Couple Intervention for Borderline Personality Disorder
NCT Number: NCT06458933
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Borderline Personality Disorder
Interventions: BEHAVIORAL: Sage|BEHAVIORAL: Supportive Individual Psychotherapy
Sponsor: York University
Collaborators: Centre for Addiction and Mental Health|Toronto Metropolitan University|University of Windsor|Kennesaw State University|University of Winnipeg|The Sashbear Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 304
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-09-01
Completion Date: 2030-08-31

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.

Primary Outcome Measures: 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 Outcome Measures: Conflict Resolution Scale, Self-report measure of relationship conflict. Scores range from 0 to 52, with higher scores reflecting higher levels of conflict resolution., 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), Self-report measure of depression. Scores range from 0 to 21, with higher scores reflecting higher levels of depression., 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), Self-report measure of anxiety. Scores range from 0 to 21, with higher scores reflecting higher levels of anxiety., 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), Self-report measure of emotion dysregulation. Scores range from 36 to 180, with higher scores reflecting higher levels of emotion dysregulation., It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Addiction Severity Index, 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., 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, Self-report measure of psychological distress. Scores range from 10 to 50, with higher scores reflecting higher levels of psychological distress., It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
Other Outcome Measures: 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., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|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., 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, 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., 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, Self-report measure of communication patterns, It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Borderline Symptom List- 23-INFORMANT REPORT, Informant-report measure of BPD severity Scores range from 0 to 92, with higher scores reflecting higher levels of partner's BPD severity., It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Humor Styles Questionnaire - affiliative subscale, Self-report measure of humour and positive communication qualities. Scores range from 8 to 56, with higher scores reflecting higher levels of humour., It will be administered people with BPD and partners at baseline (pre-intervention), 12 weeks, and 36 weeks.|Perceived Relationship Quality Component, Self-report measure of relationship satisfaction. Score ranges vary across subscales, with higher scores reflecting higher relationship quality., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Couples Satisfaction Inventory- 16 item version, Self-report measure of relationship satisfaction. Scores range from 0 to 81, with higher scores reflecting higher levels of relationship satisfaction., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Sage skills use measure, 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., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Sage skills use measure (in session), Use of Sage skills self-report measure, created for present study. Scores reflect the number of times a skill was used., It will be administered to people with BPD and partners in the Sage condition at the beginning of every session.|Feinberg Brief Co-Parenting Scale, Self-report measure of co-parenting experiences. Scores range from 0 to 72, with higher scores reflecting higher levels positive co-parenting., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Empathic accuracy measure, 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., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Working Alliance Inventory- Short form, Self-report measure of working therapeutic alliance. Scores range from 12 to 60, with higher scores reflecting a stronger therapeutic alliance., It will be administered to people with BPD and partners, as well as their therapists, approximately weekly from weeks one to 12.|Posttraumatic Checklist-5 (PCL-5), Self-report measure of PTSD symptoms. Scores range from 0 to 80, with higher scores reflecting higher levels of PTSD severity., 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 Difficulties in Emotion Regulation Scale (DERS), Informant-report measure of emotion dysregulation. Scores range from 8 to 40, with higher scores reflecting higher levels of informant-reported emotion dysregulation., 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 (people with BPD), Self-report measure of depression. Scores range from 0 to 21, with higher scores reflecting higher levels of depression., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|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., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Difficulties in Emotion Regulation Scale (DERS), Self-report measure of emotion dysregulation. Scores range from 36 to 180, with higher scores reflecting higher levels of emotion dysregulation., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Experiences of Shame Scale, Self-report measure of shame. Scores range from 25 to 100, with higher scores reflecting higher levels of shame., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Impulsive Behaviour Scale, Self-report measure of impulsive behaviour. Scores range from 25 to 125, with higher scores reflecting higher frequency of impulsive behaviour., 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 Compassion Scale-Short form, Self-report measure of self-compassion Scores range from 12 to 60, with higher scores reflecting higher levels of self-compassion., It will be administered people with BPD at baseline (pre-intervention), 12 weeks, and 36 weeks.|Multidimensional scale of perceived social support, Self-report measure of perceived social support. Scores range from 1 to 7, with higher scores reflecting higher levels of perceived social support., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Sexual functioning and satisfaction items, Singular items measuring sexual functioning and satisfaction. Higher scores generally reflect higher sexual satisfaction or frequency of sexual activity., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Break up items, Singular items measuring whether the relationship has ended., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Conflict tactics scale-2: Negotiation subscale, Self-report measure of negotiation communication. Scores range from 0 to 36, with higher scores reflecting higher levels negotiation communication., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Subjective emptiness scale, Self-report measure of emptiness. Higher scores reflect higher emptiness., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Inventory of Interpersonal Problems (IIP)- BPD subscale, Self-report measure of interpersonal problems in BPD. Scores range from 0 to 72, with higher scores reflecting higher levels of interpersonal problems., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Addiction Severity Index, 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., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|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., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Brief Inventory of Psychosocial Functioning, Self-report measure of social functioning. Scores range from 0 to 44, with higher scores reflecting more difficulties in social functioning., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Short Form (12) Health Survey, Self-report measure of health, It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Barratt Impulsiveness Scale-11, Self-report measure of impulsivity, It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Columbia Suicide Severity Rating Scale- Suicidal Ideation section, 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., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Dissociative Experiences Scale II, Self-report measure of dissociation. Higher scores reflect higher levels of dissociation., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Mental Health Utilization, Qualitative interview of measure of mental health service utilization., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Emergency Department Visits, Interview of measure of frequency of emergency department visits and reasons for them., It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|World Health Organization Quality of Life Items, 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., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Revised University of California-Los Angeles Loneliness Scale, Self-report measure of loneliness Scores range from 20 to 80, with higher scores reflecting higher levels of loneliness., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Emotion Regulation Questionnaire, 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., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Relationship Questionnaire, 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., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Mentalization Scale, Self-report measure of mentalization. Scores range from 28 to 140., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Interpersonal Needs Questionnaire, Self-report measure of perceived burdensomeness and thwarted belongingness. Higher scores reflect higher levels of perceived burdensomeness and thwarted belongingness., It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Test of Roles and Reactions in Dyads (TORRID), 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., It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|Burden assessment scale, Self-report measure of burden. Score ranges vary across subscales, with higher scores reflecting higher levels of burden., It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.|The Satisfaction With Therapy and Therapist Scale-Revised (STTS-R), 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., It will be administered to people with BPD and partners at immediately after the intervention (12 weeks).|Behavioural communication sample, 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., It will be administered to people with BPD and their partners in the Sage condition only at the first and last intervention session.