Isolating Mechanisms in the Treatment of Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

Isolating Mechanisms in the Treatment of Borderline Personality Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408860
• Other study ID #: 3842
• Secondary ID: K23MH106648-03
• Status: Completed
• Phase: N/A
• Start date: October 15, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: October 2022
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Borderline personality disorder (BPD) is a commonly occurring, severe, and costly condition that interferes greatly with quality of life. Considerable comorbidity with other disorders and existing multicomponent treatments with largely untested putative mechanisms of action represent obstacles for effective dissemination of BPD treatment; in light of this gap, the purpose of the present study is to isolate the effects of individual treatment components on putative mechanisms implicated in both BPD. This study will answer important theoretical questions about the mechanism of treatment change, and might lead to more efficacious, cost-effective, and easily disseminable treatment strategies for BPD, a severe and understudied disorder.

Description:

Borderline personality disorder (BPD) is a commonly occurring, severe, and costly condition for which treatment efforts have been hindered by several factors. First, extant treatments for BPD are long-term, intensive and consist of multiple components, largely focused on resolving the life-threatening dysregulation that characterizes this disorder. It is important to note, however, that most individuals diagnosed with BPD never attempt suicide or require inpatient hospitalization. Multi-component interventions may not be the most efficient approach for patients with less severe levels of BPD and also make it difficult to draw conclusions regarding which treatment strategies are influencing mechanisms maintaining symptoms. Additionally, extant BPD treatments do no explicitly address high rates of comorbidity with anxiety and depressive disorders; high levels of co-occurrence amongst these disorders underscores the utility of identifying transdiagnostic treatment components relevant to maintaining mechanisms across diagnostic boundaries. The proposed Mentored Patient-Oriented Research Career Development Award (K23) is a four-year plan in support of the applicant's long-term career goal to become a clinical scientist proficient in developing parsimonious, easily disseminated treatments for BPD and other emotional disorders. This project will be completed in two phases. The goal of Phase I, in line with an experimental therapeutics approach, is to investigate the effect of acting inconsistent with emotion-driven behavioral urges on emotional intensity in a sample of individuals diagnosed with BPD in the context of a single-case experiment (alternating treatment design). Phase II will also utilize single-case experimental design (in this case a multiple baseline study) to explore the effects of brief intervention focused solely on acting inconsistent to emotional action tendencies on emotional intensity, tolerance of emotions, and BPD symptoms in a sample diagnosed with BPD. Boston University's Center for Anxiety and Related Disorders, where all research and the bulk of the training activities will take place, is a world-renown clinical research institution with a successful history of treatment development research. Overall, the broader aim of these research and training goals is to address the need for improved treatments for BPD. This study will answer important theoretical questions about the mechanism of treatment change, and might lead to more efficacious, cost-effective, and easily disseminable treatment strategies for BPD, a severe and understudied disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnostic and Statistical Manual (5th Edition; DSM-5) diagnosis of borderline personality disorder;

2. willing to maintain a stable dose on prescribed psychotropic medication throughout the study duration. This avoids problems with reluctance to discontinue or difficulty with discontinuing, and also the confounding of outcomes from initiation of medication during treatment; this procedure is a longstanding practice at the Center for Anxiety and Related Disorders (CARD) at Boston University for treatment outcome research. Additionally, participants must be

3. fluent in English. Exclusion Criteria: In order to maximize generalizability, exclusion criteria are based solely on the well-being of the participant and will consist primarily of conditions that would require prioritization for immediate treatment (e.g., severe suicidality or substance dependence).

These include:

1. Current DSM-5 diagnoses of bipolar disorder, schizophrenia, schizoaffective disorder, or organic mental disorder;

2. Clear and current suicidal risk (intent);

3. Current or recent (within 3 months) history of drug dependence;

4. Willingness to refrain from additional psychosocial treatment across the course of the study; and

5. has access to own smartphone.

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Other:
• Countering Emotional Behaviors Module from Unified Protocol
This is a 4-week behavioral treatment that teaches patients to counter problematic emotional avoidance by approaching behaviors and situations that may bring up strong emotions in the short-term, but prevent interfering emotional difficulties in the long-term.

Locations

Country	Name	City	State
United States	Boston University Center for Anxiety and Related Disorders	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multidimensional Experiential Avoidance Questionnaire - Distress Aversion Subscale	The Multidimensional Experiential Avoidance Questionnaire - Distress Aversion subscale (MEAQ-DA) assesses aversive reactions to emotional experiences. Total scores representing a sum of items range from 13 to 78, which lower scores indicating more adaptive psychological functioning.	pre-treatment (baseline), post-treatment (4 weeks)
Secondary	Zanarini Rating Scale for BPD	The Zanarini Rating Scale for BPD (ZAN-BPD) is a self-report measures that assesses borderline personality disorder symptoms. The total score ranges from 0 to 27 with higher scores representing poorer psychological functioning.	pre-treatment (baseline), post-treatment (4 weeks)