Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy

Borderline Personality Disorder Clinical Trial

— MAP-DBT  

Official title:

Mapping Treatment Components to Targets in Dialectical Behavior Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626310
• Other study ID #: 1710 1R21MH119530-01A1
• Secondary ID: R21MH119530-01A1
• Status: Completed
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: February 6, 2023

Study information

• Verified date: April 2023
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 6, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Psychological Services Center, University of Massachusetts Amherst	Amherst	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst	National Institute of Mental Health (NIMH), University of Toledo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in coping strategies	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	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Primary	Change in emotional functioning	Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Primary	Change in borderline personality disorder features	Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Secondary	Change in self-reported emotional reactivity	Assessed with self-reported emotions in response to emotional cues presented in the lab	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Secondary	Change in self-reported emotional regulation	Assessed with self-reported emotions in response to regulation instructions for emotional cues presented in the lab	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Secondary	Change in affect-modulated startle	Assessed with eyeblink startle amplitude in response to emotional cues presented in the lab	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Secondary	Change in emotional habituation	Assessed with skin conductance (microsiemens) in response to repeated emotional cues presented in the lab	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Secondary	Change in physiological emotional reactivity	Assessed with skin conductance (microsiemens) in response to emotional cues presented in the lab	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Secondary	Change in deliberate physiological emotional regulation	Assessed with heart rate variability (ms2/hz) in response to emotional cues presented in the lab	Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7