Skip to main content
Clinical Trials/NCT04587518
NCT04587518
Active, not recruiting
Not Applicable

Five Factor Model Treatment for Borderline Personality Disorder

Shannon E. Sauer-Zavala1 site in 1 country40 target enrollmentSeptember 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Borderline Personality Disorder
Sponsor
Shannon E. Sauer-Zavala
Enrollment
40
Locations
1
Primary Endpoint
Change in clinician-rated borderline personality disorder symptoms
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief 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). 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.

Registry
clinicaltrials.gov
Start Date
September 3, 2020
End Date
July 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shannon E. Sauer-Zavala
Responsible Party
Sponsor Investigator
Principal Investigator

Shannon E. Sauer-Zavala

Assistant Professor

University of Kentucky

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 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 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 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.

Study Sites (1)

Loading locations...

Similar Trials