Borderline Personality DisorderPhase 2NCT06458933
Testing Interventions for Borderline Personality Disorder.
A Phase 2 study testing Sage and Supportive Individual Psychotherapy in people with Borderline Personality Disorder, run by York University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Sage and Supportive Individual Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2025to 30 Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
York University
Toronto, California, M3J1P3
Skye Fitzpatrick, PhD, skyefitz@yorku.ca
Vinushini Arunagiri, PhD, vinu89@yorku.ca
About this study
Official title: A Randomized Controlled Trial Testing Sage: A Couple Intervention 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.
Read more
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Sage, Supportive Individual Psychotherapy
- Keywords
- Borderline Personality Disorder, Relationship dysfunction, Couple therapy, Emotion dysregulation
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SageBehavioural
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 PsychotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sage | Experimental | Immediately receives 12 sessions of a couple psychotherapy designed to treat borderline personality disorder (BPD) and enhances relationship functioning simultaneously. Receives: Behavioral: Sage |
| SIP | Active comparator | Immediately receives 12 individual sessions each (12 for people with borderline personality disorder (BPD), 12 for partners) of Supportive Individual Psychotherapy (SIP). Receives: Behavioral: Supportive Individual Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
Conflict Resolution Scale
Self-report measure of relationship conflict. Scores range from 0 to 52, with higher scores reflecting higher levels of conflict resolution.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Sep 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Toronto Metropolitan University, University of Windsor, Kennesaw State University, University of Winnipeg, The Sashbear Foundation
- Responsible party
- Principal investigator, Skye Fitzpatrick, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458933
- Sponsor's protocol ID
- 495689
- Status last verified
- Feb 2026
- First submitted
- 23 May 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be posted on a public, online data repository for the purpose of sharing it with the broader scientific community, to promote integrity and transparency in our research and allow other researchers to replicate our results from an open science framework. Demographic data will be shared only in grouped form for the entire sample (e.g., the average age of the sample, the frequencies of various racial/ethnic groups in the sample) except for participant's gender, which will be posted at the individual, rather than group, level.
Publications
Fitzpatrick S, Arunagiri V, Traynor JM, Fredborg BK, Daros AR, Crenshaw AO, Fitzpatrick D, McMain SF, Monson CM, Courey L, Liebman RE. Protocol for a parallel-group superiority randomized controlled trial comparing Sage- a couple psychotherapy- to supportive individual psychotherapy for borderline personality disorder. BMC Psychiatry. 2026 Jul 23;26(1):807. doi: 10.1186/s12888-026-08374-6.
PubMed 42897533
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Testing Sage: A Couple Intervention for Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT06458933
- Acronym / sponsor ID
- 495689
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, Relationship dysfunction, Couple therapy, Emotion dysregulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Toronto Metropolitan University, University of Windsor, Kennesaw State University, University of Winnipeg, The Sashbear Foundation
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sage | Experimental | Behavioral: SageImmediately receives 12 sessions of a couple psychotherapy designed to treat borderline personality disorder (BPD) and enhances relationship functioning simultaneously. |
| SIP | Active comparator | Behavioral: Supportive Individual PsychotherapyImmediately receives 12 individual sessions each (12 for people with borderline personality disorder (BPD), 12 for partners) of Supportive Individual Psychotherapy (SIP). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SageSage 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). | Behavioural | Sage |
| Supportive Individual PsychotherapySupportive 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. | Behavioural | SIP |
Primary outcome
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 42897533Fitzpatrick S, Arunagiri V, Traynor JM, Fredborg BK, Daros AR, Crenshaw AO, Fitzpatrick D, McMain SF, Monson CM, Courey L, Liebman RE. Protocol for a parallel-group superiority randomized controlled trial comparing Sage- a couple psychotherapy- to supportive individual psychotherapy for borderline personality disorder. BMC Psychiatry. 2026 Jul 23;26(1):807. doi: 10.1186/s12888-026-08374-6.
- Individual participant dataSharing planned: Yes. De-identified data will be posted on a public, online data repository for the purpose of sharing it with the broader scientific community, to promote integrity and transparency in our research and allow other researchers to replicate our results from an open science framework. Demographic data will be shared only in grouped form for the entire sample (e.g., the average age of the sample, the frequencies of various racial/ethnic groups in the sample) except for participant's gender, which will be posted at the individual, rather than group, level.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sage and Supportive Individual Psychotherapy in people with Borderline Personality Disorder, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Skye Fitzpatrick, PhD (461-736-2100 ext. 66214, skyefitz@yorku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06458933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.