Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06458933
Study type Interventional
Source York University
Contact Skye Fitzpatrick, PhD
Phone 461-736-2100
Email skyefitz@yorku.ca
Status Not yet recruiting
Phase Phase 2
Start date September 1, 2025
Completion date August 31, 2030

See also
  Status Clinical Trial Phase
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Active, not recruiting NCT04587518 - Five Factor Model Treatment for Borderline Personality Disorder N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Completed NCT03677037 - The Short-Term MBT Project Phase 3
Not yet recruiting NCT05989529 - Delving Into Borderline Personality Disorder Clinical Trial Experiences
Completed NCT02068326 - MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial N/A
Completed NCT02518906 - Evaluation of AIT Study N/A
Recruiting NCT04296604 - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations N/A
Terminated NCT02149823 - Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations Phase 1
Completed NCT02108990 - Acetaminophen and Social Processes Phase 2
Completed NCT02988037 - Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study N/A
Not yet recruiting NCT01683136 - Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder N/A
Completed NCT01635556 - Evaluation of a Modified Dialectical Behavior Therapy Program N/A
Completed NCT02397031 - Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder N/A
Terminated NCT01103180 - Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder Phase 2
Terminated NCT01212588 - Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD) Phase 2
Terminated NCT00539188 - N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD Phase 2
Recruiting NCT05398627 - Neurofeedback for Borderline Personality Disorder N/A
Recruiting NCT03994510 - SHame prOpensity in bOrderline Personality Disorder N/A
Recruiting NCT06005129 - Personality Change Study for Borderline Personality Disorder N/A