Isolating Mechanisms in the Treatment of Borderline Personality Disorder

October 24, 2022 updated by: Shannon Sauer Zavala, Boston University Charles River Campus
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University Center for Anxiety and Related Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 2-week baseline
Patients complete assessment only for a duration of 2-weeks prior to starting the intervention: Countering Emotional Behaviors Module from the Unified Protocol.
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.
Other: 4-week baseline
Patient complete assessment only for a duration of 4-weeks prior to starting the intervention: Countering Emotional Behaviors Module from the Unified Protocol.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Multidimensional Experiential Avoidance Questionnaire - Distress Aversion Subscale
Time Frame: pre-treatment (baseline), post-treatment (4 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Zanarini Rating Scale for BPD
Time Frame: pre-treatment (baseline), post-treatment (4 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University Charles River Campus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shannon Sauer-Zavala, PhD, Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3842
  • K23MH106648-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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