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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH106648-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion 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:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon Sauer-Zavala, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Center for Anxiety and Related Disorders | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | pre-treatment (baseline), post-treatment (4 weeks) |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shannon Sauer-Zavala | University of Kentucky | 858-218-4082 | ssz@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2015 | Oct 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | pre-treatment (baseline), post-treatment (4 weeks) |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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