- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06005129
Personality Change Study for Borderline Personality Disorder
January 12, 2026 updated by: Shannon E. Sauer-Zavala
Engaging Higher-Order Mechanisms of Psychopathology: A Parsimonious Approach to Precision Medicine
Participants with borderline personality disorder will undergo an a 2 - 4 week baseline assessment to determine level of outcomes of interest in the absence of treatment.
After the baseline period, participants will receive six weekly 50-60-minute treatment sessions.
After the 6 treatment sessions, participants will complete a 4-week follow-up period to determine the sustainability of the treatment module.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40508-2307
- Clinic for Emotional Health at the University of Kentucky
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Speak English fluently
- Diagnosis of Borderline Personality Disorder
Exclusion Criteria:
- diagnosed psychological conditions that would be better addressed by alternative treatments
- concurrent psychotherapy
- medication instability
- substance use disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Personality-based treatment 2 week baseline
Participants will receive treatment tailored to 1 of 3 personality dimensions after a 2 week baseline assessment
|
Participants will be randomized to a 2- or 4-week assessment-only baseline period.
After the baseline period, participants will receive the personality-based treatment module corresponding to their highest clinical elevation (i.e., neuroticism, [low] conscientiousness, [low] agreeableness).
Treatment will consist of six weekly 50-60-minute sessions.
After the 6-week intervention period, participants will complete a 4-week follow-up period to determine the sustainability of effects observed
|
|
Experimental: Personality-based treatment 4 week baseline
Participants will receive treatment tailored to 1 of 3 personality dimensions after a 4 week baseline assessment
|
Participants will be randomized to a 2- or 4-week assessment-only baseline period.
After the baseline period, participants will receive the personality-based treatment module corresponding to their highest clinical elevation (i.e., neuroticism, [low] conscientiousness, [low] agreeableness).
Treatment will consist of six weekly 50-60-minute sessions.
After the 6-week intervention period, participants will complete a 4-week follow-up period to determine the sustainability of effects observed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in clinician-rated borderline personality disorder symptoms
Time Frame: up to 14 weeks (pre-baseline, pre-intervention, post-intervention, post-follow-up)
|
Change in borderline personality disorder symptoms will be measured using Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) - clinician-rated version.
Scores range from 0-36; higher scores indicate greater severity of borderline personality disorder symptoms
|
up to 14 weeks (pre-baseline, pre-intervention, post-intervention, post-follow-up)
|
|
Change in patient-reported borderline personality disorder symptoms
Time Frame: weekly up to 14 weeks
|
Change in borderline personality disorder symptoms will be measured using Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) - self-report version.
Scores range from 0-36; higher scores indicate greater severity of borderline personality disorder symptoms
|
weekly up to 14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shannon Sauer-Zavala, PhD, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2024
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
August 16, 2023
First Submitted That Met QC Criteria
August 16, 2023
First Posted (Actual)
August 22, 2023
Study Record Updates
Last Update Posted (Actual)
January 13, 2026
Last Update Submitted That Met QC Criteria
January 12, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 86801
- R61MH133665 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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