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Completed

NCT Number: NCT04587518

Five Factor Model Treatment for Borderline Personality Disorder

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-diagnosis of borderline personality disorder (BPD)

Exclusion criteria

  • 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

Treatment and study plan

Personality-Based Cognitive Behavioral Therapy

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Shannon E. Sauer-Zavala

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 14, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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