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

Mapping Treatment Components to Targets in Dialectical Behavior Therapy

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.

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Dialectical behavior therapy - emotion regulation skills training; Behavioral: Dialectical behavior therapy - interpersonal effectiveness skills training; Behavioral: Interpersonal psychotherapy

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: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01002
      • Psychological Services Center, University of Massachusetts Amherst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Emotional Functioning - Linear	Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties. Outcomes are reported as slopes (scores over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (DERS scores/week), and the Quadratic unit of measure (DERS scores/week^2). This measure reflects the Linear measure.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Change in Borderline Personality Disorder Features - Linear	Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms. Outcomes are reported as slopes (scores rescaled *100 over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (BSL scores/week), and the Quadratic unit of measure (BSL scores/week^2). This measure reflects the Linear measure.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Change in Emotional Functioning - Quad	Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties. Outcomes are reported as slopes (scores over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (DERS scores/week), and the Quadratic unit of measure (DERS scores/week^2). This measure reflects the Quadratic measure.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Change in Borderline Personality Disorder Features - Quad	Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms. Outcomes are reported as slopes (scores rescaled *100 over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (BSL scores/week), and the Quadratic unit of measure (BSL scores/week^2). This measure reflects the Quadratic measure.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-reported Emotional Reactivity	Assessed with self-reported emotions on the PANAS negative affect (NA) scale (mean scores on a scale of 1-5) in response to emotional scripts (Neg: neutral (Neu), negative (Neg)) by emotion regulation condition (Reg: emotional maintain instructions, and negative with decrease instructions) presented in the lab. Outcomes are reported as slopes differences in PANAS NA scores between neutral and negative-maintain over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Self-reported Emotional Regulation	Assessed with self-reported emotions on the PANAS negative affect (NA) scale (mean scores on a scale of 1-5) in response to emotional scripts (neutral (Neu), negative (Neg)) by emotion regulation condition (Reg: with emotional maintain (Main) instructions, and negative with decrease (Dec) instructions) presented in the lab. Outcomes are reported as slopes differences in PANAS NA scores between Reg conditions in response to negative stimuli (negative-decrease and negative-maintain) over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/ multilevel models.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Affect-modulated Startle	Assessed with eyeblink startle amplitude (mV) in response to emotional cues presented in the lab (of note, per protocol, we examined eyeblink in response to negative and neutral image stimuli across initial [novel] and repeated presentations) which were presented along with sound bursts to elicit startle. This outcome was transformed and then rescaled (*100, = mVtr). Outcomes are reported as slopes per condition over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models with image valence (Neg: negative vs. neutral) and type (Novel: novel vs. repeated) within-person condition effects.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Emotional Habituation	Assessed with skin conductance (SC; microsiemens, μS) in response to emotional cues presented in the lab (of note, per protocol, we examined DV in response to negative and neutral image stimuli [Neg] across initial [Novel] and repeated presentations) which were presented along with sound bursts to elicit startle. Data were transformed to address skew (μStr). Outcomes are reported as novel x negative slopes (SLP) over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects / multilevel models.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Physiological Emotional Reactivity	Assessed with skin conductance (SC; microsiemens, μS) in response to emotional scripts (Neg: neutral, negative) by emotion regulation (Reg: emotional maintain instructions, and negative with decrease instructions) presented in the lab. Data were transformed to address skew (μStr). Outcomes are reported as slopes of Negative (Neg) condition effects on SC over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects / multilevel models.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Deliberate Physiological Emotional Regulation	Assessed with high frequency heart rate variability (HRV, ms2/hz) in response to emotional scripts (Negative: negative vs. neutral) with emotion regulation instructions (Reg: Maintain vs. Decrease in the Negative condition) presented in the lab. Data were transformed to address skew (ms2/hztr). Outcomes are reported as slopes of the effect of the Reg condition on HRV over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects /multilevel models.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Coping Strategies - Linear	Assessed with the DBT-Ways of Coping Checklist (DBT-WCCL, transformed = DBTWCCLtr), which yields scales of skills use (DSS, rescaled *100), general dysfunctional coping (DC1, rescaled *10), and blaming others (DC2, *10), with scores of 0-3, higher reflects greater use. Outcomes are reported as slopes (with SE) centered around treatment start per condition, extracted from mixed effects/multilevel models (separately per scale score).This measure is listed separately to permit presentation of two units of measure (that are in the same model) for the DC1 scale, which was fit best with a quadratic model, whereas the remaining scales only required a Linear model. This measure reflects the Linear measures (DBTWCCL/week) for all scales.	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Change in Coping Strategies - Quad	Assessed with the DBT-Ways of Coping Checklist (DBT-WCCL, transformed = DBTWCCLtr), which yields scales of skills use (DSS, rescaled *100), general dysfunctional coping (DC1, rescaled *10), and blaming others (DC2, *10), with scores of 0-3, higher reflects greater use. Outcomes are reported as slopes (SE) centered around treatment start per condition, extracted from mixed effects/multilevel models (separately per scale score).This measure is listed separately to permit presentation of two units of measure (that are in the same model) for the DC1 scale, which was fit best with a quadratic model, whereas the remaining scales only required a Linear model. This measure reflects the Quadratic measure (DBTWCCL/week^2).	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst
• Collaborators: National Institute of Mental Health (NIMH); University of Toledo
• Investigators: Principal Investigator: Katherine L Dixon-Gordon, PhD, University of Massachusetts, Amherst

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): February 6, 2023

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trials; Emotions; Dialectical behavior therapy; Behavior and Behavior mechanisms
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: 1710 1R21MH119530-01A1; R21MH119530-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No