Personality-Based Therapy for Borderline Personality Disorder

Overseen By Shannon Sauer-Zavala, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shannon E. Sauer-Zavala

Disqualifiers: Psychological conditions, Psychotherapy, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new therapy for individuals with borderline personality disorder, focusing on individual personality traits. Participants first undergo a 2 to 4-week period to assess their condition without treatment. Then, they attend six weekly therapy sessions tailored to their personality, followed by a month-long check-in period to evaluate the therapy's lasting effects. This trial is open to English speakers diagnosed with borderline personality disorder who are not currently in therapy or managing unstable medications. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could shape future therapies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions 'medication instability' as an exclusion criterion, which might mean your medication needs to be stable before joining.

What prior data suggests that this therapy is safe for treating borderline personality disorder?

Research shows that therapies for borderline personality disorder, like the one under study, are usually well-tolerated. For example, mentalization-based treatment (MBT), a common therapy for this condition, has proven safe in various studies. Participants in these studies reported few negative side effects.

While specific data on the therapy tested in this trial is unavailable, the study's focus beyond early safety testing suggests existing safety evidence. Additionally, other similar therapies for borderline personality disorder have been used safely, indicating this therapy might also be well-tolerated. However, each therapy can differ, so monitoring during the trial remains important.

Prospective participants should discuss any concerns with the study team or a healthcare provider. They can provide more detailed information based on individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Personality-Based Therapy for Borderline Personality Disorder because it offers a personalized approach that tailors treatment to individual personality dimensions. Unlike traditional treatments like Dialectical Behavior Therapy or Cognitive Behavioral Therapy, which have a one-size-fits-all approach, this therapy considers the unique personality traits of each participant. By customizing the therapeutic process based on specific personality dimensions after a baseline assessment, this method aims to address the root causes of the disorder more effectively and potentially improve outcomes. This innovative approach could lead to more targeted and effective interventions for individuals with Borderline Personality Disorder.

What evidence suggests that this trial's treatments could be effective for borderline personality disorder?

Research shows that psychotherapy can be more effective than standard treatments for borderline personality disorder (BPD). Studies indicate that specialized therapies can greatly reduce BPD symptoms. Effect sizes, ranging from 0.50 to 0.65, measure the impact of these therapies, indicating a moderate to strong reduction in symptoms. In this trial, participants will receive Personality-Based Therapy tailored to one of three personality dimensions. Although limited data exists on Personality-Based Therapy specifically, similar therapies have improved overall personality functioning and reduced psychiatric symptoms. ^{1 2 5 6 7}

Who Is on the Research Team?

Shannon Sauer-Zavala, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals diagnosed with Borderline Personality Disorder. It's not suitable for those who have other psychological conditions needing different treatments, are currently in psychotherapy, have substance use disorders, or whose medication use isn't stable.

Inclusion Criteria

I have been diagnosed with Borderline Personality Disorder.

Exclusion Criteria

I am currently undergoing psychotherapy.

My medication doses have been stable recently.

I have a mental health condition that needs different treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a 2-4 week baseline assessment to determine level of outcomes of interest in the absence of treatment

2-4 weeks

Treatment

Participants receive six weekly 50-60-minute treatment sessions tailored to 1 of 3 personality dimensions

6 weeks

Follow-up

Participants are monitored for sustainability of the treatment module after the treatment sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personality-Based Therapy

Trial Overview The study tests a new therapy specifically designed for personality changes in people with Borderline Personality Disorder. Participants will first be observed without treatment and then receive six weekly sessions of the therapy to see its effects.

How Is the Trial Designed?

Group I: Personality-based treatment 4 week baseline Experimental Treatment 1 Intervention

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

Group II: Personality-based treatment 2 week baseline Experimental Treatment 1 Intervention

Participants will receive treatment tailored to 1 of 3 personality dimensions after a 2 week baseline assessment

Personality-Based Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Personality-Based Therapy for:

• Borderline Personality Disorder

Approved in European Union as Personality-Based Therapy for:

• Borderline Personality Disorder

Approved in Canada as Personality-Based Therapy for:

• Borderline Personality Disorder

Who Is Running the Clinical Trial?

Shannon E. Sauer-Zavala

Lead Sponsor

Trials

5

Recruited

400+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

American Psychological Foundation

Collaborator

Trials

20

Recruited

2,200+

Published Research Related to This Trial

Psychiatry residents trained in Dialectical Behavior Therapy (DBT) showed significantly higher confidence and willingness to treat patients with borderline personality disorder (BPD) compared to those trained in standard care, based on a study involving 57 residents over a 3-month rotation.

Key factors contributing to the increased confidence included exposure to high-risk patients and a team-based treatment structure, highlighting the effectiveness of DBT training in preparing residents for real-world clinical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Dialectical Behavior Therapy Psychiatry Residency Training Program. Carmel, A., Logvinenko, E., Valenti, ES.[2022]

Specialized psychotherapies for borderline personality disorder, including dialectical behavior therapy, show moderate effectiveness in reducing overall disorder severity, based on a systematic review of 20 studies with 1375 participants.

Dialectical behavior therapy specifically demonstrated a small to medium effect in reducing self-injury compared to standard treatment, indicating its potential as a targeted intervention for certain symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specialized psychotherapies for adults with borderline personality disorder: A systematic review and meta-analysis. Oud, M., Arntz, A., Hermens, ML., et al.[2019]

In a study of 346 individual sessions of mentalization-based treatment (MBT) for borderline personality disorder, the most common intervention was therapists checking their own understanding, highlighting the importance of therapist self-awareness in the treatment process.

Qualitative analysis revealed a hidden psychopedagogical agenda in MBT, suggesting that incorporating explicit pedagogical strategies—like fostering independent reasoning and mental flexibility—could enhance the effectiveness of therapy for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pedagogical stance in mentalization-based treatment. Folmo, EJ., Langjord, T., Myhrvold, NCS., et al.[2022]

Dialectical behavior therapy (DBT) is a promising cognitive-behavioral treatment for borderline personality disorder, but more empirical evidence is needed to fully establish its effectiveness in community settings.

DBT is appealing to practitioners due to its structured approach, addressing various functional areas, but there are barriers to implementation that require strategic solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing dialectical behavior therapy. Swenson, CR., Torrey, WC., Koerner, K.[2022]

Dialectical behavior therapy (DBT) has gained popularity as an effective treatment for various personality disorders, originally designed for individuals with borderline personality disorder (BPD) but now applied to diverse populations including those with substance dependence and antisocial behaviors.

The paper reviews recent literature on DBT's effectiveness and discusses ongoing controversies regarding its application, indicating a need for further research to clarify its benefits across different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for personality disorders. Rizvi, SL., Linehan, MM.[2019]

In a study involving 114 patients with borderline personality disorder, both day hospital MBT (MBT-DH) and intensive out-patient MBT (MBT-IOP) showed significant improvements in symptom severity and other measures over 18 months, with moderate to very large effect sizes for both treatments.

While MBT-DH was not found to be superior to MBT-IOP in reducing symptom severity, it demonstrated a tendency towards greater effectiveness in improving relational functioning, suggesting that different treatment intensities may lead to different recovery trajectories for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Day hospital versus intensive out-patient mentalisation-based treatment for borderline personality disorder: multicentre randomised clinical trial. Smits, ML., Feenstra, DJ., Eeren, HV., et al.[2021]

In a study involving 166 adult outpatients with borderline personality disorder (BPD), short-term mentalization-based therapy (MBT) (5 months) was found to be equally effective as long-term MBT (14 months) in reducing BPD symptoms and improving quality of life, functioning, and self-harm rates.

However, the long-term MBT group experienced a higher rate of serious adverse events, particularly psychiatric hospitalizations, suggesting that longer treatment may not be safer and does not provide additional benefits over shorter treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT). Juul, S., Jakobsen, JC., Hestbaek, E., et al.[2023]

Both Dialectical Behaviour Therapy (DBT) and Mentalization-Based Therapy (MBT) help reduce self-harm in patients with borderline personality disorder by teaching skills like impulse control, questioning thoughts, and effective communication, as shown in a study of 73 patients over 12 months.

Patients in MBT reported more difficulties with group interactions compared to those in DBT, highlighting the importance of managing therapeutic relationships to prevent negative effects on treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient experiences of therapy for borderline personality disorder: Commonalities and differences between dialectical behaviour therapy and mentalization-based therapy and relation to outcomes. Barnicot, K., Redknap, C., Coath, F., et al.[2022]

In a study of 90 patients with borderline personality disorder over 12 months, those receiving dialectical behaviour therapy (DBT) showed a significantly greater reduction in self-harm incidents and emotional dysregulation compared to those receiving mentalisation-based therapy (MBT).

While both therapies were effective, DBT demonstrated superior outcomes in reducing self-harm and improving emotional regulation, suggesting it may be more effective for certain symptoms of borderline personality disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behaviour therapy v. mentalisation-based therapy for borderline personality disorder. Barnicot, K., Crawford, M.[2022]

Mentalization-based treatment (MBT) is effective for patients with borderline personality disorder (BPD), including those with severe conditions, as it showed consistent clinical benefits regardless of severity, unlike psychodynamic group-based treatment (PDT).

In a study of 345 BPD patients over three years, higher clinical severity negatively impacted outcomes in PDT, while MBT maintained effectiveness, suggesting it may be a better option for severely disordered patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mentalization-based treatment or psychodynamic treatment programmes for patients with borderline personality disorder - the impact of clinical severity. Kvarstein, EH., Pedersen, G., Folmo, E., et al.[2020]

Recent studies (2015-2018) indicate that mentalization-based treatment (MBT) can significantly improve clinical outcomes for individuals with personality disorders, especially those with borderline personality disorder (BPD).

The mechanism of change in MBT appears to involve enhancing mentalizing abilities, but more rigorous and larger-scale studies are needed to confirm its efficacy and effectiveness across a broader range of personality disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mentalization-Based Treatment for Personality Disorders: Efficacy, Effectiveness, and New Developments. Volkert, J., Hauschild, S., Taubner, S.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10786009/

Borderline personality disorder: a comprehensive review of ... Compared to treatment as usual, psychotherapy has proved to be more efficacious, with effect sizes between 0.50 and 0.65 with regard to core BPD ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6151959/

Specialized psychotherapies for adults with borderline ... There is moderate quality evidence that specialized psychotherapies are effective in reducing overall borderline personality disorder severity.

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05014217

Study Details | NCT05014217 | Comparing Mentalization- ... The study compares the effectiveness of two psychotherapies for borderline personality disorder, mentalization-based therapy and a modified version of Linehan's ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/cpp.70120

Mentalization‐Based Therapy for Borderline Personality ... Mentalization-based therapy (MBT) is an evidence-based treatment for borderline personality disorder (BPD) and the second most studied psychotherapeutic ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05865-2

Mentalization based treatment for a broad range of personality ... Overall, enrollment in the MBT program was associated with a decrease in psychiatric symptoms and an improvement of personality functioning, ...

6. neuroscigroup.us neuroscigroup.us/articles/ADA-11-200.php

Evidence Psychotherapy Options for Borderline Personality ... SFT is based on Young's model of Early Maladaptive Schema, developing the schema-focused therapy, integrating cognitive therapy with Gestalt and object ...

7. mayoclinic.org mayoclinic.org/diseases-conditions/borderline-personality-disorder/diagnosis-treatment/drc-20370242

Borderline personality disorder - Diagnosis and treatment DBT includes group and individual therapy designed to treat borderline personality disorder. DBT uses a skills-based approach to teach you how ...