NCT06005129

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

August 16, 2023

Last Update Submit

January 12, 2026

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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

Study Arms (2)

Personality-based treatment 2 week baseline

EXPERIMENTAL

Participants will receive treatment tailored to 1 of 3 personality dimensions after a 2 week baseline assessment

Behavioral: Personality-Based Therapy

Personality-based treatment 4 week baseline

EXPERIMENTAL

Participants will receive treatment tailored to 1 of 3 personality dimensions after a 4 week baseline assessment

Behavioral: Personality-Based Therapy

Interventions

Personality-Based TherapyBEHAVIORAL

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

Personality-based treatment 2 week baselinePersonality-based treatment 4 week baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Speak English fluently
  • Diagnosis of Borderline Personality Disorder

You may not qualify if:

  • diagnosed psychological conditions that would be better addressed by alternative treatments
  • concurrent psychotherapy
  • medication instability
  • substance use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Emotional Health at the University of Kentucky

Lexington, Kentucky, 40508-2307, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Shannon Sauer-Zavala, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 22, 2023

Study Start

September 15, 2024

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

US(1)