Clinical trial NCT06458933: Sage: A Couple Intervention for Borderline Personality Disorder
Official title: A Randomized Controlled Trial Testing Sage: A Couple Intervention for Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
Relationship dysfunction
Couple therapy
Emotion dysregulation
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
name: Toronto Metropolitan University
name: University of Windsor
name: Kennesaw State University
name: University of Winnipeg
name: The Sashbear Foundation
First posted: 2024-06-14
Enrollment: 304
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: INCLUSION CRITERIA

1. 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)
2. Both members are at least 19-years-old
3. Both members consent to study participation
4. Both members consent to having assessment interviews and treatment sessions audio- and video-recorded
5. Both members members reside in Ontario (with no plan to leave the province during the course of the study)
6. Both members members are fluent in English
7. Both members are willing to receive emails about the study
8. Both members have regular internet access from a private location for completion of study appointments

EXCLUSION CRITERIA:

1. Severe intimate partner violence in their relationship in the past year (Endorsement of severe intimate partner violence items on Conflict Tactics Scale-2)
2. DSM-5 criteria A and B of schizophrenia, not better accounted for by BPD
3. Hospitalization in the past year for mania, or mania in the past three months
4. A substance/alcohol use disorder that is likely to require medical intervention (e.g., detoxification) to reduce use
5. A medical condition that is likely to require hospitalization within the next year
6. Scaled score below 70 on the Test of Premorbid Functioning, suggesting below average intelligence and/or traumatic brain injury
7. 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.
8. The participant 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
9. The couple is currently receiving couple therapy and is unwilling to pause the therapy for the duration of the active treatment phase

Primary outcomes:
measure: Zanarini Rating Scale for BPD (ZAN-BPD)
timeFrame: 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:
measure: Conflict Resolution Scale
timeFrame: 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: Depression, Anxiety, and Stress Scale- depression subscale (partners)
timeFrame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Addiction Severity Index
timeFrame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Kessler Psychological Distress Scale-10
timeFrame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
Other outcomes:
measure: Suicide Attempt Self-Injury Interview-modified
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Borderline Symptom List- 23
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Positive and Negative Affect Schedule (PANAS)- select subscales
timeFrame: 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.
measure: Communication Patterns Questionnaire-23 item version
timeFrame: 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: Borderline Symptom List- 23-INFORMANT REPORT
timeFrame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Humor Styles Questionnaire - affiliative subscale
timeFrame: It will be administered people with BPD and partners at baseline (pre-intervention), 12 weeks, and 36 weeks.
measure: Perceived Relationship Quality Component
timeFrame: 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: Couples Satisfaction Inventory- 16 item version
timeFrame: 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: Sage skills use measure
timeFrame: 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: Sage skills use measure (in session)
timeFrame: It will be administered to people with BPD and partners in the Sage condition at the beginning of every session.
measure: Feinberg Brief Co-Parenting Scale
timeFrame: 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: Empathic accuracy measure
timeFrame: 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: Working Alliance Inventory- Short form
timeFrame: It will be administered to people with BPD and partners, as well as their therapists, approximately weekly from weeks one to 12.
measure: Posttraumatic Checklist-5 (PCL-5)
timeFrame: 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: Informant Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 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: Depression, Anxiety, and Stress Scale- depression subscale (people with BPD)
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Experiences of Shame Scale
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Impulsive Behaviour Scale
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Self Compassion Scale-Short form
timeFrame: It will be administered people with BPD at baseline (pre-intervention), 12 weeks, and 36 weeks.
measure: Multidimensional scale of perceived social support
timeFrame: 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: Sexual functioning and satisfaction items
timeFrame: 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: Break up items
timeFrame: 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: Conflict tactics scale-2: Negotiation subscale
timeFrame: 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: Subjective emptiness scale
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Inventory of Interpersonal Problems (IIP)- BPD subscale
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Addiction Severity Index
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Kessler Psychological Distress Scale-10
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Brief Inventory of Psychosocial Functioning
timeFrame: 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: Short Form (12) Health Survey
timeFrame: 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: Barratt Impulsiveness Scale-11
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Columbia Suicide Severity Rating Scale- Suicidal Ideation section
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Dissociative Experiences Scale II
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Mental Health Utilization
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Emergency Department Visits
timeFrame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: World Health Organization Quality of Life Items
timeFrame: 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: Revised University of California-Los Angeles Loneliness Scale
timeFrame: 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: Emotion Regulation Questionnaire
timeFrame: 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: Relationship Questionnaire
timeFrame: 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: Mentalization Scale
timeFrame: 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: Interpersonal Needs Questionnaire
timeFrame: 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: Test of Roles and Reactions in Dyads (TORRID)
timeFrame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: Burden assessment scale
timeFrame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
measure: The Satisfaction With Therapy and Therapist Scale-Revised (STTS-R)
timeFrame: It will be administered to people with BPD and partners at immediately after the intervention (12 weeks).
measure: Behavioural communication sample
timeFrame: It will be administered to people with BPD and their partners in the Sage condition only at the first and last intervention session.
Locations:
Study officials:
References: