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NCT06005129 Clinical Trial

Personality Change Study for Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:
Engaging Higher-Order Mechanisms of Psychopathology: A Parsimonious Approach to Precision Medicine

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06005129
Other study ID # 86801
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2023
Est. completion date August 1, 2025

Study information
Verified date September 2023
Source University of Kentucky
Contact Shannon Sauer-Zavala, PhD
Phone (859) 562-1570
Email tipslab@uky.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Personality-Based Therapy
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

Locations
Country Name City State
United States Clinic for Emotional Health at the University of Kentucky Lexington Kentucky

Sponsors (2)
Lead Sponsor Collaborator
Shannon E. Sauer-Zavala American Psychological Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 up to 14 weeks (pre-baseline, pre-intervention, post-intervention, post-follow-up)
Primary 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 weekly up to 14 weeks
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