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Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy (MAP-DBT)

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - interpersonal effectiveness skills training
Interpersonal psychotherapy
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Borderline Personality Disorder focused on measuring Dialectical behavior therapy, Emotions, Behavior and Behavior mechanisms, Randomized Controlled Trials

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. exhibit 4+ BPD symptoms,
  2. have a history of recent (i.e., past-year) and recurrent (> 1 instance) of self-injury,
  3. commit to participate in one of our 6-week experimental groups,
  4. have an individual health provider who can manage imminent issues,
  5. be between 18-60 years old,

Exclusion Criteria:

  1. not fluent in English,
  2. have impaired (uncorrected) vision or hearing that would impair ability to understand study stimuli,
  3. a current manic, psychotic, or active physiological dependence on substances (to limit interference in the lab),
  4. low cognitive functioning (IQ ≤ 70.4 (TOPF; Pearson Assessments, 2009),
  5. past DBT treatment

Sites / Locations

  • Psychological Services Center, University of Massachusetts Amherst

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Dialectical behavior therapy - emotion regulation skills training

Dialectical behavior therapy - interpersonal effectiveness skills training

Non-skills-oriented interpersonal psychotherapy group

Arm Description

Dialectical behavior therapy - emotion regulation skills training

Dialectical behavior therapy - interpersonal effectiveness skills training

Non-skills-oriented interpersonal psychotherapy group

Outcomes

Primary Outcome Measures

Change in emotional functioning
Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties
Change in borderline personality disorder features
Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms

Secondary Outcome Measures

Change in self-reported emotional reactivity
Assessed with self-reported emotions in response to emotional cues presented in the lab
Change in self-reported emotional regulation
Assessed with self-reported emotions in response to regulation instructions for emotional cues presented in the lab
Change in affect-modulated startle
Assessed with eyeblink startle amplitude in response to emotional cues presented in the lab
Change in emotional habituation
Assessed with skin conductance (microsiemens) in response to repeated emotional cues presented in the lab
Change in physiological emotional reactivity
Assessed with skin conductance (microsiemens) in response to emotional cues presented in the lab
Change in deliberate physiological emotional regulation
Assessed with heart rate variability (ms2/hz) in response to emotional cues presented in the lab

Full Information

First Posted
November 1, 2020
Last Updated
April 14, 2023
Sponsor
University of Massachusetts, Amherst
Collaborators
National Institute of Mental Health (NIMH), University of Toledo
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1. Study Identification

Unique Protocol Identification Number
NCT04626310
Brief Title
Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy
Acronym
MAP-DBT
Official Title
Mapping Treatment Components to Targets in Dialectical Behavior Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
February 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Amherst
Collaborators
National Institute of Mental Health (NIMH), University of Toledo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Although dialectical behavior therapy (DBT) skills training is effective in the treatment of borderline personality disorder, it contains four skills modules and there is little research to guide their modular application. This study compares the unique effects of two distinct DBT skills training modules, relative to a non-DBT therapy group for adults with borderline personality disorder. Using innovative laboratory-based assessment methods, the proposed study will examine the effects of these conditions on emotional responding and interpersonal functioning, as well as clinical outcomes.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Dialectical behavior therapy, Emotions, Behavior and Behavior mechanisms, Randomized Controlled Trials

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialectical behavior therapy - emotion regulation skills training
Arm Type
Experimental
Arm Description
Dialectical behavior therapy - emotion regulation skills training
Arm Title
Dialectical behavior therapy - interpersonal effectiveness skills training
Arm Type
Experimental
Arm Description
Dialectical behavior therapy - interpersonal effectiveness skills training
Arm Title
Non-skills-oriented interpersonal psychotherapy group
Arm Type
Active Comparator
Arm Description
Non-skills-oriented interpersonal psychotherapy group
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavior therapy - emotion regulation skills training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavior therapy - interpersonal effectiveness skills training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in emotional functioning
Description
Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties
Time Frame
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Title
Change in borderline personality disorder features
Description
Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms
Time Frame
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Secondary Outcome Measure Information:
Title
Change in self-reported emotional reactivity
Description
Assessed with self-reported emotions in response to emotional cues presented in the lab
Time Frame
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Title
Change in self-reported emotional regulation
Description
Assessed with self-reported emotions in response to regulation instructions for emotional cues presented in the lab
Time Frame
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Title
Change in affect-modulated startle
Description
Assessed with eyeblink startle amplitude in response to emotional cues presented in the lab
Time Frame
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Title
Change in emotional habituation
Description
Assessed with skin conductance (microsiemens) in response to repeated emotional cues presented in the lab
Time Frame
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Title
Change in physiological emotional reactivity
Description
Assessed with skin conductance (microsiemens) in response to emotional cues presented in the lab
Time Frame
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Title
Change in deliberate physiological emotional regulation
Description
Assessed with heart rate variability (ms2/hz) in response to emotional cues presented in the lab
Time Frame
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Other Pre-specified Outcome Measures:
Title
Change in coping strategies
Description
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
Time Frame
Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L Dixon-Gordon, PhD
Organizational Affiliation
University of Massachusetts, Amherst
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychological Services Center, University of Massachusetts Amherst
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01002
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared via NDA.
IPD Sharing Time Frame
Data are expected to be cleaned scored and uploaded by Jan 2024
IPD Sharing Access Criteria
Data will be available through NDA

Learn more about this trial

Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy

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