ClinicalTrials.gg
CompletedNCT03408860Updated Nov 16, 2022Results posted

Isolating Mechanisms in the Treatment of Borderline Personality Disorder

An interventional study of Countering Emotional Behaviors Module from Unified Protocol in Borderline Personality Disorder, sponsored by Boston University Charles River Campus. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-16.

Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 81 studies in Borderline Personality Disorder with a site in United States — 15 open to participants now, 17 under way, none of them phase 3. Borderline Personality Disorder · United States.

Enrollment
67th of 71
8 · median 56
Started
2017
with 1 other
No phase
39 of 81
9 open now
Registered
43rd of 81
by date

Among the 81 studies in Borderline Personality Disorder with a site in United States, this one is the 67th largest by enrollment of the 71 interventional ones that give a count, is one of 2 that started in 2017, is one of 39 with no phase, and was the 43rd registered.

Borderline Personality Disorder

278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.

Browse Borderline Personality Disorder studies →

Open to participants now

15 of the 81 studies in Borderline Personality Disorder with a site in United States are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Borderline Personality Disorder
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnostic and Statistical Manual (5th Edition; ) 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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • 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

  • 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

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.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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)

07

Results

Posted Nov 16, 2022

Participant flow

Participant flow — Overall Study
Milestone2-week Baseline4-week Baseline
Started44
Completed44
Not completed00

Outcome measures

PrimaryMultidimensional 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)
Reported as:
Mean · score on a scale
Multidimensional Experiential Avoidance Questionnaire - Distress Aversion Subscale
score on a scale2-week Baseline4-week Baseline
pre-treatment23.21 ± 7.1523.21 ± 7.15
post-treatment19.93 ± 7.9519.93 ± 7.95
SecondaryZanarini 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)
Reported as:
Mean · score on a scale
Zanarini Rating Scale for BPD
score on a scale2-week Baseline4-week Baseline
pre-treatment9.59 ± 4.719.59 ± 4.71
post treatment7.12 ± 5.787.12 ± 5.78

Adverse events

Collected over 16 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
2-week Baseline0/4 (0%)0/4 (0%)0/4 (0%)
4-week Baseline0/4 (0%)0/4 (0%)0/4 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)2-week Baseline4-week BaselineTotal
Mean22.67 (19 to 27)20.75 (19 to 24)21.57 (19 to 27)
Sex: Female, Male
Sex: Female, Male(Participants)2-week Baseline4-week BaselineTotal
Female235
Male213
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)2-week Baseline4-week BaselineTotal
Race — Asian235
Race — African American101
Race — White112
Region of Enrollment
Region of Enrollment(participants)2-week Baseline4-week BaselineTotal
United States448
08

Study locations

1 site
  • Boston University Center for Anxiety and Related Disorders
    Boston, Massachusetts 02215, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Aug 2020, 34 months.

Results were first posted in Nov 2022, 2 years 2 months after primary completion.

Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's 34 months is close to that.

Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2018
First posted
Jan 24, 2018
StartActual
Oct 15, 2017
Primary completionActual
Aug 30, 2020
CompletionActual
Aug 30, 2020
Results first posted
Nov 16, 2022
Last update
Nov 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03408860
Responsible party
Shannon Sauer Zavala (Research Associate Professor, Boston University Charles River Campus) — Principal investigator
First posted
Jan 24, 2018
Start date
Oct 15, 2017
Primary completion
Aug 30, 2020
Completion
Aug 30, 2020
Results posted
Nov 16, 2022
Last update
Nov 16, 2022

Study contacts

Shannon Sauer-Zavala, PhD
principal investigator · Boston University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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