Borderline Personality DisorderNCT06005129
Personality Change Study for Borderline Personality Disorder
A study testing Personality-Based Therapy in people with Borderline Personality Disorder, run by Shannon E. Sauer-Zavala at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Personality-Based Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2024to 2 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speak English fluently
- Diagnosis of Borderline Personality Disorder
Who cannot join
- diagnosed psychological conditions that would be better addressed by alternative treatments
- concurrent psychotherapy
- medication instability
- substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinic for Emotional Health at the University of Kentucky
Lexington, Kentucky, 40508-2307
About this study
Official title: Engaging Higher-Order Mechanisms of Psychopathology: A Parsimonious Approach to Precision Medicine
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Personality-Based Therapy
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personality-Based TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Personality-based treatment 2 week baseline | Experimental | Participants will receive treatment tailored to 1 of 3 personality dimensions after a 2 week baseline assessment Receives: 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 Receives: Behavioral: Personality-Based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: weekly up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start15 Sep 2024
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shannon E. Sauer-Zavala
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Shannon E. Sauer-Zavala, University of Kentucky
- Investigators
- Shannon Sauer-Zavala, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005129
- Sponsor's protocol ID
- 86801
- Other IDs
- R61MH133665
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Higher-Order Mechanisms of Psychopathology: A Parsimonious Approach to Precision Medicine
- ClinicalTrials.gov ID
- NCT06005129
- Acronym / sponsor ID
- 86801
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Shannon E. Sauer-ZavalaUniversity, hospital or other
- Collaborators
- American Psychological Foundation, National Institute of Mental Health (NIMH)
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personality-based treatment 2 week baseline | Experimental | Behavioral: Personality-Based TherapyParticipants will receive treatment tailored to 1 of 3 personality dimensions after a 2 week baseline assessment |
| Personality-based treatment 4 week baseline | Experimental | Behavioral: Personality-Based TherapyParticipants will receive treatment tailored to 1 of 3 personality dimensions after a 4 week baseline assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Speak English fluently
- Diagnosis of Borderline Personality Disorder
Key exclusion criteria (4 listed)
- diagnosed psychological conditions that would be better addressed by alternative treatments
- concurrent psychotherapy
- medication instability
- substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personality-Based TherapyParticipants 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 | Behavioural | Personality-based treatment 2 week baseline, Personality-based treatment 4 week baseline |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Sauer-Zavala, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personality-Based Therapy in people with Borderline Personality Disorder, run by Shannon E. Sauer-Zavala at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinician-rated borderline personality disorder symptoms (time frame: up to 14 weeks (pre-baseline, pre-intervention, post-intervention, post-follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.