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Personality Change Study for Borderline Personality Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06005129
Recruitment Status : Recruiting
First Posted : August 22, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborator:
American Psychological Foundation
Information provided by (Responsible Party):
Shannon E. Sauer-Zavala, University of Kentucky

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : September 15, 2023
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in clinician-rated borderline personality disorder symptoms [ Time Frame: 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

  2. Change in patient-reported borderline personality disorder symptoms [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06005129


Contacts
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Contact: Shannon Sauer-Zavala, PhD (859) 562-1570 tipslab@uky.edu

Locations
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United States, Kentucky
Clinic for Emotional Health at the University of Kentucky Recruiting
Lexington, Kentucky, United States, 40508-2307
Contact: Shannon E Sauer-Zavala    859-562-1570    tipslab@uky.ed   
Sponsors and Collaborators
Shannon E. Sauer-Zavala
American Psychological Foundation
Investigators
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Principal Investigator: Shannon Sauer-Zavala, PhD University of Kentucky
More Information
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Responsible Party: Shannon E. Sauer-Zavala, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT06005129    
Other Study ID Numbers: 86801
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders