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Isolating Mechanisms in the Treatment of Borderline Personality Disorder

Isolating Mechanisms in the Treatment of Borderline Personality Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03408860
Enrollment
8
Registered
2018-01-24
Start date
2017-10-15
Completion date
2020-08-30
Last updated
2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

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.

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.

Interventions

OTHERCountering 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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Boston University Charles River Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Multidimensional Experiential Avoidance Questionnaire - Distress Aversion Subscalepre-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.

Secondary

MeasureTime frameDescription
Zanarini Rating Scale for BPDpre-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
4
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. 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.
4
Total8

Baseline characteristics

Characteristic2-week Baseline4-week BaselineTotal
Age, Continuous22.67 Years20.75 Years21.57 Years
Race/Ethnicity, Customized
Race
African American
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race
Asian
2 Participants3 Participants5 Participants
Race/Ethnicity, Customized
Race
White
1 Participants1 Participants2 Participants
Region of Enrollment
United States
4 participants4 participants8 participants
Sex: Female, Male
Female
2 Participants3 Participants5 Participants
Sex: Female, Male
Male
2 Participants1 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 40 / 4
other
Total, other adverse events
0 / 40 / 4
serious
Total, serious adverse events
0 / 40 / 4

Outcome results

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.

Time frame: pre-treatment (baseline), post-treatment (4 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
2-week BaselineMultidimensional Experiential Avoidance Questionnaire - Distress Aversion Subscalepre-treatment23.21 score on a scaleStandard Deviation 7.15
2-week BaselineMultidimensional Experiential Avoidance Questionnaire - Distress Aversion Subscalepost-treatment19.93 score on a scaleStandard Deviation 7.95
4-week BaselineMultidimensional Experiential Avoidance Questionnaire - Distress Aversion Subscalepre-treatment23.21 score on a scaleStandard Deviation 7.15
4-week BaselineMultidimensional Experiential Avoidance Questionnaire - Distress Aversion Subscalepost-treatment19.93 score on a scaleStandard Deviation 7.95
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.

Time frame: pre-treatment (baseline), post-treatment (4 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
2-week BaselineZanarini Rating Scale for BPDpre-treatment9.59 score on a scaleStandard Deviation 4.71
2-week BaselineZanarini Rating Scale for BPDpost treatment7.12 score on a scaleStandard Deviation 5.78
4-week BaselineZanarini Rating Scale for BPDpost treatment7.12 score on a scaleStandard Deviation 5.78
4-week BaselineZanarini Rating Scale for BPDpre-treatment9.59 score on a scaleStandard Deviation 4.71

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026