Personality Change Study for Borderline Personality Disorder
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ClinicalTrials.gov Identifier: NCT06005129 |
Recruitment Status :
Recruiting
First Posted : August 22, 2023
Last Update Posted : September 21, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Borderline Personality Disorder | Behavioral: Personality-Based Therapy | Not Applicable |
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 |
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
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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 |
- 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
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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
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
Contact: Shannon Sauer-Zavala, PhD | (859) 562-1570 | tipslab@uky.edu |
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 |
Principal Investigator: | Shannon Sauer-Zavala, PhD | University of Kentucky |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Personality Disorders Borderline Personality Disorder Mental Disorders |