NCT04587518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3.7 years

First QC Date

October 7, 2020

Last Update Submit

September 10, 2024

Conditions

Keywords

borderline personality disordertreatmentCBTfive-factor model

Outcome Measures

Primary Outcomes (5)

  • 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)

  • 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)

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

Participants in this group will receive the intervention immediately.

Behavioral: Personality-Based Cognitive Behavioral Therapy

Waitlist/Delayed Treatment

EXPERIMENTAL

Participants in this group will receive the intervention after an 18-week wait.

Behavioral: Personality-Based Cognitive Behavioral Therapy

Interventions

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.

Immediate TreatmentWaitlist/Delayed Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of borderline personality disorder (BPD)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (1)

  • Sauer-Zavala S, Southward MW, Fruhbauerova M, Semcho SA, Stumpp NE, Hood CO, Smith M, Elhusseini S, Cravens L. BPD compass: A randomized controlled trial of a short-term, personality-based treatment for borderline personality disorder. Personal Disord. 2023 Sep;14(5):534-544. doi: 10.1037/per0000612. Epub 2023 Jan 2.

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Shannon Sauer-Zavala

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 14, 2020

Study Start

September 3, 2020

Primary Completion

May 3, 2024

Study Completion

May 3, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations