Clinical trial NCT04587518: Five Factor Model Treatment for Borderline Personality Disorder
Official title: Five Factor Model Treatment for Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: borderline personality disorder
treatment
CBT
five-factor model
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in clinician-rated borderline personality disorder symptoms
timeFrame: 44 weeks (baseline, post-treatment/waitlist, 6 month follow-up)
measure: Change in patient-reported borderline personality disorder symptoms
timeFrame: 18 weeks (week 1[baseline for immediate treatment condition, post-waitlist for delayed treatment condition], week, 2, week 3, week, 4.....week 18)
measure: Change in clinician-rated clinical severity
timeFrame: 44 weeks (baseline, post-treatment/waitlist, 6 month follow-up)
measure: Change in Anxiety Symptoms
timeFrame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
measure: Change in Depressive Symptoms
timeFrame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Shannon Sauer-Zavala
role: PRINCIPAL_INVESTIGATOR
References: