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Five Factor Model Treatment for Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personality-Based Cognitive Behavioral Therapy
Sponsored by
Shannon E. Sauer-Zavala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring borderline personality disorder, treatment, CBT, five-factor model

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate Treatment

Waitlist/Delayed Treatment

Arm Description

Participants in this group will receive the intervention immediately.

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

Outcomes

Primary Outcome Measures

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
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
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2020
Last Updated
March 9, 2023
Sponsor
Shannon E. Sauer-Zavala
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1. Study Identification

Unique Protocol Identification Number
NCT04587518
Brief Title
Five Factor Model Treatment for Borderline Personality Disorder
Official Title
Five Factor Model Treatment for Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shannon E. Sauer-Zavala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
borderline personality disorder, treatment, CBT, five-factor model

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
Participants in this group will receive the intervention immediately.
Arm Title
Waitlist/Delayed Treatment
Arm Type
Experimental
Arm Description
Participants in this group will receive the intervention after an 18-week wait.
Intervention Type
Behavioral
Intervention Name(s)
Personality-Based Cognitive Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in clinician-rated borderline personality disorder symptoms
Description
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
Time Frame
44 weeks (baseline, post-treatment/waitlist, 6 month follow-up)
Title
Change in patient-reported borderline personality disorder symptoms
Description
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
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)
Title
Change in clinician-rated clinical severity
Description
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.
Time Frame
44 weeks (baseline, post-treatment/waitlist, 6 month follow-up)
Title
Change in Anxiety Symptoms
Description
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.
Time Frame
12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Title
Change in Depressive Symptoms
Description
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.
Time Frame
12 weeks (baseline, week 1, week, 2, week, 3.....week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Sauer-Zavala
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Five Factor Model Treatment for Borderline Personality Disorder

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