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

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ClinicalTrials.gov Identifier: NCT04626310
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : February 16, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
The University of Toledo
Information provided by (Responsible Party):
Katherine Dixon-Gordon, University of Massachusetts, Amherst

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Behavioral: Dialectical behavior therapy - emotion regulation skills training Behavioral: Dialectical behavior therapy - interpersonal effectiveness skills training Behavioral: Interpersonal psychotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mapping Treatment Components to Targets in Dialectical Behavior Therapy
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dialectical behavior therapy - emotion regulation skills training
Dialectical behavior therapy - emotion regulation skills training
Behavioral: 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
Dialectical behavior therapy - interpersonal effectiveness skills training
Behavioral: 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
Non-skills-oriented interpersonal psychotherapy group
Behavioral: Interpersonal psychotherapy
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 Measures :
  1. Change in emotional functioning [ Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14 ]
    Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Change in emotional habituation [ Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7 ]
    Assessed with skin conductance (microsiemens) in response to repeated emotional cues presented in the lab

  5. 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

  6. 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


Other Outcome Measures:
  1. Change in coping strategies [ Time Frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626310


Contacts
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Contact: Katherine L Dixon-Gordon, PhD 413-354-0053 katiedg@umass.edu

Locations
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United States, Massachusetts
Psychological Services Center, University of Massachusetts Amherst Recruiting
Amherst, Massachusetts, United States, 01002
Contact: Katherine L Dixon-Gordon, PhD    413-545-0226    caslab@psych.umass.edu   
Sponsors and Collaborators
University of Massachusetts, Amherst
National Institute of Mental Health (NIMH)
The University of Toledo
Investigators
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Principal Investigator: Katherine L Dixon-Gordon, PhD University of Massachusetts, Amherst
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Responsible Party: Katherine Dixon-Gordon, Associate Professor, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT04626310    
Other Study ID Numbers: 1710 1R21MH119530-01A1
R21MH119530-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Specific data archive decisions are pending.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katherine Dixon-Gordon, University of Massachusetts, Amherst:
Dialectical behavior therapy
Emotions
Behavior and Behavior mechanisms
Randomized Controlled Trials
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders