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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

Tracking Information
First Submitted Date  ICMJE November 1, 2020
First Posted Date  ICMJE November 12, 2020
Last Update Posted Date February 16, 2021
Actual Study Start Date  ICMJE October 26, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 6, 2020)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy
Official Title  ICMJE Mapping Treatment Components to Targets in Dialectical Behavior Therapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Borderline Personality Disorder
Intervention  ICMJE
  • 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.

  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Dialectical behavior therapy - emotion regulation skills training
    Dialectical behavior therapy - emotion regulation skills training
    Intervention: Behavioral: Dialectical behavior therapy - emotion regulation skills training
  • Experimental: Dialectical behavior therapy - interpersonal effectiveness skills training
    Dialectical behavior therapy - interpersonal effectiveness skills training
    Intervention: Behavioral: Dialectical behavior therapy - interpersonal effectiveness skills training
  • Active Comparator: Non-skills-oriented interpersonal psychotherapy group
    Non-skills-oriented interpersonal psychotherapy group
    Intervention: Behavioral: Interpersonal psychotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2020)
81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katherine L Dixon-Gordon, PhD 413-354-0053 katiedg@umass.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04626310
Other Study ID Numbers  ICMJE 1710 1R21MH119530-01A1
R21MH119530-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Specific data archive decisions are pending.
Responsible Party Katherine Dixon-Gordon, University of Massachusetts, Amherst
Study Sponsor  ICMJE University of Massachusetts, Amherst
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • The University of Toledo
Investigators  ICMJE
Principal Investigator: Katherine L Dixon-Gordon, PhD University of Massachusetts, Amherst
PRS Account University of Massachusetts, Amherst
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP