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Completed

NCT Number: NCT04626310

Mapping Aspects of Psychotherapy 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.

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Key information

Conditions

Borderline Personality Disorder Behavior Mental Disorders Personality Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychological Services Center, University of Massachusetts Amherst

Amherst, Massachusetts, 01002, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • exhibit 4+ BPD symptoms,
  • have a history of recent (i.e., past-year) and recurrent (> 1 instance) of self-injury,
  • commit to participate in one of our 6-week experimental groups,
  • have an individual health provider who can manage imminent issues,
  • be between 18-60 years old,

Exclusion criteria

  • not fluent in English,
  • have impaired (uncorrected) vision or hearing that would impair ability to understand study stimuli,
  • a current manic, psychotic, or active physiological dependence on substances (to limit interference in the lab),
  • low cognitive functioning (IQ ≤ 70.4 (TOPF; Pearson Assessments, 2009),
  • past DBT treatment

Treatment and study plan

Dialectical behavior therapy - emotion regulation skills training

Behavioral

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.

Dialectical behavior therapy - interpersonal effectiveness skills training

Behavioral

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.

interpersonal psychotherapy

Behavioral

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 outcomes

  1. Change in Emotional Functioning - Linear

    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. 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.

  2. Change in Borderline Personality Disorder Features - Linear

    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. 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.

  3. Change in Emotional Functioning - Quad

    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. 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.

  4. Change in Borderline Personality Disorder Features - Quad

    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. 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.

Secondary outcomes

  1. Change in Self-reported Emotional Reactivity

    Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

    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.

  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 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.

  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 (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.

  4. Change in Emotional Habituation

    Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

    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.

  5. Change in Physiological Emotional Reactivity

    Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

    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.

  6. Change in Deliberate Physiological Emotional Regulation

    Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

    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.

Other outcomes

  1. Change in Coping Strategies - Linear

    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, 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.

  2. Change in Coping Strategies - Quad

    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, 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).

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Toledo

Registry information

Official study title

Mapping Treatment Components to Targets in Dialectical Behavior Therapy

Acronym: MAP-DBT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 12, 2020
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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