Five Factor Model Treatment for Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

Five Factor Model Treatment for Borderline Personality Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04587518
• Other study ID #: 60042
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Shannon E. Sauer-Zavala

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)