- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04626310
Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy (MAP-DBT)
Mapping Treatment Components to Targets in Dialectical Behavior Therapy
Study Overview
Status
Conditions
Detailed Description
Borderline personality disorder (BPD) is a severe mental health condition with high morbidity and mortality. Although dialectical behavior therapy (DBT) is an efficacious treatment for BPD, it is resource-intensive and lengthy in its full form, involving one year of weekly individual therapy and group skills training in mindfulness, emotion regulation, interpersonal effectiveness, and distress tolerance. As a result, few patients have access to the full treatment. A better understanding of how the distinct components of DBT affect different sets of symptoms could help to streamline this treatment and personalize its use with specific patients.
Improvements in both interpersonal and emotional functioning are theorized to underlie improvements in BPD. Thus, emotion regulation and interpersonal effectiveness skills training may be particularly important components of DBT. Therefore, this study examines the unique effects of two distinct DBT skills training modules.
Participants are adults with BPD and recent, recurrent self-injurious behaviors (planned N = 81) who are randomly assigned to six weeks of DBT emotion regulation skills training (DBT-ER), DBT interpersonal effectiveness skills training (DBT-IE), or a non-skills control group. Using innovative laboratory-based multimethod assessments, this study examines the effects of these conditions on emotional responding and interpersonal functioning, as well as BPD related outcomes. Aim 1 examines the unique effects of DBT-ER and DBT-IE on their respective emotion-related (subjective and biological emotional reactivity, behavioral emotion regulation, skills use) and interpersonal (subjective and behavioral) targets, compared to the non-DBT treatment. Aim 2 examines whether improved emotional functioning predicts reductions in BPD symptoms and self-injury. Aim 3 examines whether baseline emotion dysregulation interacts with treatment condition to predict treatment response.
The proposed research is innovative in its experimental examination of the effects of DBT components on specific targets in BPD. Given the high societal costs of BPD, this work has important public health significance. Findings will inform larger studies evaluating the potential modular use of DBT components to result in briefer and more efficient individualized treatments for patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Amherst, Massachusetts, United States, 01002
- Psychological Services Center, University of Massachusetts Amherst
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- exhibit 4+ BPD symptoms,
- have a history of recent (i.e., past-year) and recurrent (> 1 instance) of self-injury,
- commit to participate in one of our 6-week experimental groups,
- have an individual health provider who can manage imminent issues,
- be between 18-60 years old,
Exclusion Criteria:
- not fluent in English,
- have impaired (uncorrected) vision or hearing that would impair ability to understand study stimuli,
- a current manic, psychotic, or active physiological dependence on substances (to limit interference in the lab),
- low cognitive functioning (IQ ≤ 70.4 (TOPF; Pearson Assessments, 2009),
- past DBT treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dialectical behavior therapy - emotion regulation skills training
|
Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions. Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions. |
Experimental: Dialectical behavior therapy - interpersonal effectiveness skills training
|
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition.
This group involves 6 weekly sessions.
|
Active Comparator: Non-skills-oriented interpersonal psychotherapy group
|
Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context.
This group involves 6 weekly sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in emotional functioning
Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
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Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties
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Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
|
Change in borderline personality disorder features
Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
|
Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms
|
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported emotional reactivity
Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
|
Assessed with self-reported emotions in response to emotional cues presented in the lab
|
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
|
Change in self-reported emotional regulation
Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
|
Assessed with self-reported emotions in response to regulation instructions for emotional cues presented in the lab
|
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
|
Change in affect-modulated startle
Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
|
Assessed with eyeblink startle amplitude in response to emotional cues presented in the lab
|
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
|
Change in emotional habituation
Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
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Assessed with skin conductance (microsiemens) in response to repeated emotional cues presented in the lab
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Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
|
Change in physiological emotional reactivity
Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
|
Assessed with skin conductance (microsiemens) in response to emotional cues presented in the lab
|
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
|
Change in deliberate physiological emotional regulation
Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
|
Assessed with heart rate variability (ms2/hz) in response to emotional cues presented in the lab
|
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in coping strategies
Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
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Assessed with the DBT-Ways of Coping Checklist (DBT-WCCL), which yields scales of skills use, general dysfunctional coping, and blaming others, with mean scores of 0-3, with higher levels indicating greater use of those strategies
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Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
|
Collaborators and Investigators
Investigators
- Principal Investigator: Katherine L Dixon-Gordon, PhD, University of Massachusetts, Amherst
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1710 1R21MH119530-01A1
- R21MH119530-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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