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

• ClinicalTrials.gov Identifier: NCT04626310
• Recruitment Status: Completed
• First Posted: November 12, 2020
• Last Update Posted: April 18, 2023
• Sponsor: University of Massachusetts, Amherst
• Collaborators: National Institute of Mental Health (NIMH); University of Toledo
• Information provided by (Responsible Party): Katherine Dixon-Gordon, University of Massachusetts, Amherst

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
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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 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
• Actual Primary Completion Date: February 6, 2023
• Actual Study Completion Date: February 6, 2023

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 [ 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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Massachusetts

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)

University of Toledo

Investigators

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

More Information

• 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
• Last Update Posted: April 18, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

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

• 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:

Personality Disorders; Borderline Personality Disorder; Mental Disorders