Isolating Mechanisms in the Treatment of Borderline Personality Disorder

NCT03408860 | Completed Results

• 2 other identifiers: 3842K23MH106648-03
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Zanarini Rating Scale for BPD

  pre-treatment (baseline), post-treatment (4 weeks)

Study Arms (2)

2-week baseline

OTHER

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

4-week baseline

OTHER

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

Interventions

Countering Emotional Behaviors Module from Unified Protocol OTHER

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.

2-week baseline; 4-week baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic and Statistical Manual (5th Edition; DSM-5) diagnosis of borderline personality disorder;
• 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
• fluent in English.

You may not qualify if:

• Current DSM-5 diagnoses of bipolar disorder, schizophrenia, schizoaffective disorder, or organic mental disorder;
• Clear and current suicidal risk (intent);
• Current or recent (within 3 months) history of drug dependence;
• Willingness to refrain from additional psychosocial treatment across the course of the study; and
• has access to own smartphone.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Boston University Center for Anxiety and Related Disorders

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Results Point of Contact

• Title: Shannon Sauer-Zavala
• Organization: University of Kentucky

ssz@uky.edu

858-218-4082

Study Officials

• Shannon Sauer-Zavala, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 24, 2018
• Study Start: October 15, 2017
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: November 16, 2022
• Results First Posted: November 16, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)