Back to resultsPersonality Change Study for Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personality-Based Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder
Eligibility Criteria
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
Sites / Locations
- Clinic for Emotional Health at the University of KentuckyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Personality-based treatment 2 week baseline
Personality-based treatment 4 week baseline
Arm Description
Participants will receive treatment tailored to 1 of 3 personality dimensions after a 2 week baseline assessment
Participants will receive treatment tailored to 1 of 3 personality dimensions after a 4 week baseline assessment
Outcomes
Primary Outcome Measures
Change in clinician-rated borderline personality disorder symptoms
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
Change in patient-reported borderline personality disorder symptoms
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
Secondary Outcome Measures
Full Information
NCT ID
NCT06005129
First Posted
August 16, 2023
Last Updated
September 19, 2023
Sponsor
Shannon E. Sauer-Zavala
Collaborators
American Psychological Foundation
1. Study Identification
Unique Protocol Identification Number
NCT06005129
Brief Title
Personality Change Study for Borderline Personality Disorder
Official Title
Engaging Higher-Order Mechanisms of Psychopathology: A Parsimonious Approach to Precision Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shannon E. Sauer-Zavala
Collaborators
American Psychological Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personality-based treatment 2 week baseline
Arm Type
Experimental
Arm Description
Participants will receive treatment tailored to 1 of 3 personality dimensions after a 2 week baseline assessment
Arm Title
Personality-based treatment 4 week baseline
Arm Type
Experimental
Arm Description
Participants will receive treatment tailored to 1 of 3 personality dimensions after a 4 week baseline assessment
Intervention Type
Behavioral
Intervention Name(s)
Personality-Based Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in clinician-rated borderline personality disorder symptoms
Description
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
Time Frame
up to 14 weeks (pre-baseline, pre-intervention, post-intervention, post-follow-up)
Title
Change in patient-reported borderline personality disorder symptoms
Description
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
Time Frame
weekly up to 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Sauer-Zavala, PhD
Phone
(859) 562-1570
Email
tipslab@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Sauer-Zavala, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Emotional Health at the University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508-2307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon E Sauer-Zavala
Phone
859-562-1570
Email
tipslab@uky.ed
12. IPD Sharing Statement
Learn more about this trial
Personality Change Study for Borderline Personality Disorder
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