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.

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Personality-Based Cognitive Behavioral Therapy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Treatment; Participants in this group will receive the intervention immediately.	Behavioral: Personality-Based Cognitive Behavioral Therapy; 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.
Experimental: Waitlist/Delayed Treatment; Participants in this group will receive the intervention after an 18-week wait.	Behavioral: Personality-Based Cognitive Behavioral Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
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	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	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.	44 weeks (baseline, post-treatment/waitlist, 6 month follow-up)

Collaborators and Investigators

• Sponsor: Shannon E. Sauer-Zavala
• Investigators: Principal Investigator: Shannon Sauer-Zavala, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): May 3, 2024
• Study Completion (Actual): May 3, 2024

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 10, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: treatment; borderline personality disorder; CBT; five-factor model
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: 60042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No