MAP-DBT: Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy

Sponsor
University of Massachusetts, Amherst (Other)
Overall Status
Recruiting
CT.gov ID
NCT04626310
Collaborator
National Institute of Mental Health (NIMH) (NIH), The University of Toledo (Other)
81
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14.2
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dialectical behavior therapy - emotion regulation skills training
  • Behavioral: Dialectical behavior therapy - interpersonal effectiveness skills training
  • Behavioral: Interpersonal psychotherapy
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Oct 26, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in emotional functioning [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 [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Psychological Services Center, University of Massachusetts Amherst Amherst Massachusetts United States 01002

Sponsors and Collaborators

  • University of Massachusetts, Amherst
  • National Institute of Mental Health (NIMH)
  • The University of Toledo

Investigators

  • Principal Investigator: Katherine L Dixon-Gordon, PhD, University of Massachusetts, Amherst

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katherine Dixon-Gordon, Associate Professor, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier:
NCT04626310
Other Study ID Numbers:
  • 1710 1R21MH119530-01A1
  • R21MH119530-01A1
First Posted:
Nov 12, 2020
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Katherine Dixon-Gordon, Associate Professor, University of Massachusetts, Amherst
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2021