Clinical trial NCT04626310: Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy
Official title: Mapping Treatment Components to Targets in Dialectical Behavior Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Dialectical behavior therapy
Emotions
Behavior and Behavior mechanisms
Randomized Controlled Trials
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Toledo
First posted: 2020-11-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Change in Emotional Functioning - Linear
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
measure: Change in Borderline Personality Disorder Features - Linear
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
measure: Change in Emotional Functioning - Quad
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
measure: Change in Borderline Personality Disorder Features - Quad
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Secondary outcomes:
measure: Change in Self-reported Emotional Reactivity
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
measure: Change in Self-reported Emotional Regulation
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
measure: Change in Affect-modulated Startle
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
measure: Change in Emotional Habituation
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
measure: Change in Physiological Emotional Reactivity
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
measure: Change in Deliberate Physiological Emotional Regulation
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Other outcomes:
measure: Change in Coping Strategies - Linear
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
measure: Change in Coping Strategies - Quad
timeFrame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Locations:
city: Amherst
country: United States
facility: Psychological Services Center, University of Massachusetts Amherst
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Katherine L Dixon-Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References: