Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy

Not Applicable

Completed

Conditions: Borderline Personality Disorder

Registration Number: NCT04626310

Lead Sponsor: University of Massachusetts, Amherst

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 84

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Emotional Functioning - Linear	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.
Change in Borderline Personality Disorder Features - Linear	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.
Change in Emotional Functioning - Quad	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.
Change in Borderline Personality Disorder Features - Quad	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 Outcome Measures

Name	Time	Method
Change in Self-reported Emotional Reactivity	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.
Change in Self-reported Emotional Regulation	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.
Change in Affect-modulated Startle	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.
Change in Emotional Habituation	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.
Change in Physiological Emotional Reactivity	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.
Change in Deliberate Physiological Emotional Regulation	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.

Trial Locations

Locations (1): Psychological Services Center, University of Massachusetts Amherst
🇺🇸
Amherst, Massachusetts, United States
Psychological Services Center, University of Massachusetts Amherst
🇺🇸Amherst, Massachusetts, United States