Personality Change Study for Borderline Personality Disorder

Sponsor

Shannon E. Sauer-Zavala (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06005129

Collaborator

American Psychological Foundation (Other)

Enrollment

Location

Arms

22.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder	Behavioral: Personality-Based Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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	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
Experimental: Personality-based treatment 4 week baseline Participants will receive treatment tailored to 1 of 3 personality dimensions after a 4 week baseline assessment	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

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

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

Experimental: Personality-based treatment 4 week baseline

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

Behavioral: Personality-Based Therapy

Outcome Measures

Primary Outcome Measures

Change in clinician-rated borderline personality disorder symptoms [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
Change in patient-reported borderline personality disorder symptoms [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic for Emotional Health at the University of Kentucky	Lexington	Kentucky	United States	40508-2307

Sponsors and Collaborators

Shannon E. Sauer-Zavala
American Psychological Foundation

Investigators

Principal Investigator: Shannon Sauer-Zavala, PhD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shannon E. Sauer-Zavala, Associate Professor, University of Kentucky

ClinicalTrials.gov Identifier:

NCT06005129

Other Study ID Numbers:

86801

First Posted:

Aug 22, 2023

Last Update Posted:

Aug 22, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Personality Disorders

Borderline Personality Disorder

Study Results

No Results Posted as of Aug 22, 2023