Sage: A Couple Intervention for Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458933
• Other study ID #: 495689
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2025
• Est. completion date: August 31, 2030

Study information

• Verified date: June 2024
• Source: York University
• Contact: Skye Fitzpatrick, PhD
• Phone: 461-736-2100
• Email: skyefitz[@]yorku.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 304
• Est. completion date: August 31, 2030
• Est. primary completion date: May 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Sage
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
Supportive Individual Psychotherapy (SIP) is a comparator in our control condition reflects enhanced usual care (i.e., case management/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 (referred to in other trials as case management; Linehan et al., 2015) that has been successfully used as a standard care control for individual therapy contact in BPD treatment RCTs (Linehan et al., 2015). This intervention involves conducting a needs assessment, providing resources/information (e.g., referrals), offering assistance with problems in living (e.g., eviction), and providing supportive, empathic responses.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
York University	Centre for Addiction and Mental Health, Kennesaw State University, The Sashbear Foundation, Toronto Metropolitan University, University of Windsor, University of Winnipeg

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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).
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.