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: R61MH133665
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: University of Kentucky
• Contact: Shannon Sauer-Zavala, PhD
• Phone: (859) 562-1570
• Email: tipslab[@]uky.edu
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

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 (3)

Lead Sponsor	Collaborator
Shannon E. Sauer-Zavala	American Psychological Foundation, National Institute of Mental Health (NIMH)

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