Borderline Personality DisorderNCT04587518
Five Factor Model Treatment for Borderline Personality Disorder
A study testing Personality-Based Cognitive Behavioral Therapy in people with Borderline Personality Disorder, run by Shannon E. Sauer-Zavala at 1 site in United States.
Trial summary
The primary purpose of this study is to explore acceptability, feasibility, and preliminary efficacy of a novel cognitive-behavioral treatment for borderline personality disorder (BPD). 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 Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2020to 3 May 2024
- 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
- -diagnosis of borderline personality disorder (BPD)
Who cannot join
- diagnosed psychological conditions that would be better addressed by alternative treatments
- previously received more than 5 sessions of cognitive behavioral therapy in the past 5 years
- concurrent psychotherapy
- medication instability
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is to explore acceptability, feasibility, and preliminary efficacy of a novel cognitive-behavioral treatment for borderline personality disorder (BPD). Extant treatments for this condition are intensive, long-term (usually at least one year), and have, understandably, focused on targeting the life-threatening and therapy-interrupting behaviors that often characterize this disorder. BPD, however, is a heterogeneous disorder with diagnostic criteria that can be combined to create over 300 unique symptom presentations (Ellis, Abrams, \& Abrams, 2008); to date, no treatments have been explicitly designed with lower risk presentations of BPD in mind. This is unfortunate, as there is evidence to suggest that the majority of individuals with BPD do not demonstrate the recurrent life-threatening behaviors that warrant intensive, long-term care (Trull, Useda, Conforti, \& Doan, 1997; Zimmerman \& Coryell, 1989). Additionally, various studies have shown that the difficulties experienced by individuals with BPD can be understood as manifestations of maladaptive variants of personality traits (e.g., Mullins-Sweatt et al., 2012). Specifically, individuals with BPD demonstrate high levels of neuroticism, and low levels of agreeableness (antagonism) and conscientiousness (disinhibition); these traits may not be universally present across all individuals with BPD, perhaps underscoring the heterogeneity in presentations of this condition.
- Conditions
- Borderline Personality Disorder
- Being tested
- Personality-Based Cognitive Behavioral Therapy
- Keywords
- borderline personality disorder, treatment, CBT, five-factor model
- 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 Cognitive Behavioral TherapyBehavioural
The study treatment will take place across 18-sessions. The first session will involve psychoeducation regarding BPD.The next two sessions with include exercises drawn from Behavioral Activation (i.e., identification of value-based goals) and Motivational Interviewing (i.e., pros and cons [long and short-term consequences] of tolerating emotions, engaging in prosocial behavior, and delaying gratification). Next, patients will receive 5 sessions of cognitive interventions (i.e., cognitive reappraisal related to situations/emotions, schema related to relationships, 5 sessions of behavior change skills (i.e., acting opposite to emotion-driven urges, exposure, assertiveness training), and 5 sessions of mindfulness skills (i.e., nonjudgmental emotion awareness, compassion training, urge surfing). Finally, treatment will conclude with 2 sessions of Relapse Prevention strategies. All sessions will last for 60 minutes in duration.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Participants in this group will receive the intervention immediately. Receives: Behavioral: Personality-Based Cognitive Behavioral Therapy |
| Waitlist/Delayed Treatment | Experimental | Participants in this group will receive the intervention after an 18-week wait. Receives: Behavioral: Personality-Based Cognitive Behavioral 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: 44 weeks (baseline, post-treatment/waitlist, 6 month 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: 18 weeks (week 1[baseline for immediate treatment condition, post-waitlist for delayed treatment condition], week, 2, week 3, week, 4.....week 18)
Change in clinician-rated clinical severity
Clinical severity will be measured using the Diagnostic Interview for Anxiety, Mood, and Obsessive Compulsive and Related Neuropsychiatric Disorders (DIAMOND) dimensional clinician ratings. Scores range from 1-7; higher scores indicate greater severity.
Measured: 44 weeks (baseline, post-treatment/waitlist, 6 month follow-up)
Change in Anxiety Symptoms
Anxiety symptoms will be measured using the Overall Anxiety Severity and Interference Scale (OASIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms.
Measured: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Change in Depressive Symptoms
Depressive symptoms will be measured using the Overall Depression Severity and Interference Scale (ODSIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms.
Measured: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start3 Sep 2020
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shannon E. Sauer-Zavala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shannon E. Sauer-Zavala, University of Kentucky
- Investigators
- Shannon Sauer-Zavala, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587518
- Sponsor's protocol ID
- 60042
- Status last verified
- Sep 2024
- First submitted
- 7 Oct 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sauer-Zavala S, Kushner M, Croom H, Terrill D, Cecil S, Maynard C, Hines A, Stumpp N, Fruhbauerova M, Buchenberger V, Southward MW. Change in personality functioning during treatment with BPD compass. Personal Disord. 2026 May;17(3):189-199. doi: 10.1037/per0000762. Epub 2026 Mar 2.
PubMed 41770158Sauer-Zavala S, Southward MW, Fruhbauerova M, Semcho SA, Stumpp NE, Hood CO, Smith M, Elhusseini S, Cravens L. BPD compass: A randomized controlled trial of a short-term, personality-based treatment for borderline personality disorder. Personal Disord. 2023 Sep;14(5):534-544. doi: 10.1037/per0000612. Epub 2023 Jan 2.
PubMed 36595435
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Factor Model Treatment for Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT04587518
- Acronym / sponsor ID
- 60042
- Conditions
- Borderline Personality Disorder
- Keywords
- borderline personality disorder, treatment, CBT, five-factor model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shannon E. Sauer-ZavalaUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 14 Oct 2020 (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.
The primary purpose of this study is to explore acceptability, feasibility, and preliminary efficacy of a novel cognitive-behavioral treatment for borderline personality disorder (BPD). Extant treatments for this condition are intensive, long-term (usually at least one year), and have, understandably, focused on targeting the life-threatening and therapy-interrupting behaviors that often characterize this disorder. BPD, however, is a heterogeneous disorder with diagnostic criteria that can be combined to create over 300 unique symptom presentations (Ellis, Abrams, \& Abrams, 2008); to date, no treatments have been explicitly designed with lower risk presentations of BPD in mind. This is unfortunate, as there is evidence to suggest that the majority of individuals with BPD do not demonstrate the recurrent life-threatening behaviors that warrant intensive, long-term care (Trull, Useda, Conforti, \& Doan, 1997; Zimmerman \& Coryell, 1989). Additionally, various studies have shown that the difficulties experienced by individuals with BPD can be understood as manifestations of maladaptive variants of personality traits (e.g., Mullins-Sweatt et al., 2012). Specifically, individuals with BPD demonstrate high levels of neuroticism, and low levels of agreeableness (antagonism) and conscientiousness (disinhibition); these traits may not be universally present across all individuals with BPD, perhaps underscoring the heterogeneity in presentations of this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Personality-Based Cognitive Behavioral TherapyParticipants in this group will receive the intervention immediately. |
| Waitlist/Delayed Treatment | Experimental | Behavioral: Personality-Based Cognitive Behavioral TherapyParticipants in this group will receive the intervention after an 18-week wait. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -diagnosis of borderline personality disorder (BPD)
Key exclusion criteria (4 listed)
- diagnosed psychological conditions that would be better addressed by alternative treatments
- previously received more than 5 sessions of cognitive behavioral therapy in the past 5 years
- concurrent psychotherapy
- medication instability
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 Cognitive Behavioral TherapyThe study treatment will take place across 18-sessions. The first session will involve psychoeducation regarding BPD.The next two sessions with include exercises drawn from Behavioral Activation (i.e., identification of value-based goals) and Motivational Interviewing (i.e., pros and cons [long and short-term consequences] of tolerating emotions, engaging in prosocial behavior, and delaying gratification). Next, patients will receive 5 sessions of cognitive interventions (i.e., cognitive reappraisal related to situations/emotions, schema related to relationships, 5 sessions of behavior change skills (i.e., acting opposite to emotion-driven urges, exposure, assertiveness training), and 5 sessions of mindfulness skills (i.e., nonjudgmental emotion awareness, compassion training, urge surfing). Finally, treatment will conclude with 2 sessions of Relapse Prevention strategies. All sessions will last for 60 minutes in duration. | Behavioural | Immediate Treatment, Waitlist/Delayed Treatment |
Primary outcome
Change in clinician-rated borderline personality disorder symptoms
Time frame: 44 weeks (baseline, post-treatment/waitlist, 6 month 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: 18 weeks (week 1[baseline for immediate treatment condition, post-waitlist for delayed treatment condition], week, 2, week 3, week, 4.....week 18)
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
Change in clinician-rated clinical severity
Time frame: 44 weeks (baseline, post-treatment/waitlist, 6 month follow-up)
Clinical severity will be measured using the Diagnostic Interview for Anxiety, Mood, and Obsessive Compulsive and Related Neuropsychiatric Disorders (DIAMOND) dimensional clinician ratings. Scores range from 1-7; higher scores indicate greater severity.
Change in Anxiety Symptoms
Time frame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Anxiety symptoms will be measured using the Overall Anxiety Severity and Interference Scale (OASIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms.
Change in Depressive Symptoms
Time frame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Depressive symptoms will be measured using the Overall Depression Severity and Interference Scale (ODSIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety 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 19 Sep 2024.
- Derived from this study: PubMed 41770158Sauer-Zavala S, Kushner M, Croom H, Terrill D, Cecil S, Maynard C, Hines A, Stumpp N, Fruhbauerova M, Buchenberger V, Southward MW. Change in personality functioning during treatment with BPD compass. Personal Disord. 2026 May;17(3):189-199. doi: 10.1037/per0000762. Epub 2026 Mar 2.
- Derived from this study: PubMed 36595435Sauer-Zavala S, Southward MW, Fruhbauerova M, Semcho SA, Stumpp NE, Hood CO, Smith M, Elhusseini S, Cravens L. BPD compass: A randomized controlled trial of a short-term, personality-based treatment for borderline personality disorder. Personal Disord. 2023 Sep;14(5):534-544. doi: 10.1037/per0000612. Epub 2023 Jan 2.
- Individual participant dataSharing planned: No
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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 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 Cognitive Behavioral 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 1 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 19 Sep 2024. 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: 44 weeks (baseline, post-treatment/waitlist, 6 month follow-up)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587518, which also lists 2 linked publications.
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 19 Sep 2024.