Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy

NCT04626310 | Completed Results DMC

• 2 other identifiers: 1710 1R21MH119530-01A1R21MH119530-01A1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

Dialectical behavior therapy; Emotions; Behavior and Behavior mechanisms; Randomized Controlled Trials

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Change in Self-reported Emotional Reactivity

  Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

• Change in Self-reported Emotional Regulation

  Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

• Change in Affect-modulated Startle

  Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

• Change in Emotional Habituation

  Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

• Change in Physiological Emotional Reactivity

  Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7

Other Outcomes (2)

• Change in Coping Strategies - Linear

  Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

• Change in Coping Strategies - Quad

  Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14

Study Arms (3)

Dialectical behavior therapy - emotion regulation skills training

EXPERIMENTAL

Dialectical behavior therapy - emotion regulation skills training

Behavioral: Dialectical behavior therapy - emotion regulation skills training

Dialectical behavior therapy - interpersonal effectiveness skills training

EXPERIMENTAL

Dialectical behavior therapy - interpersonal effectiveness skills training

Behavioral: Dialectical behavior therapy - interpersonal effectiveness skills training

Non-skills-oriented interpersonal psychotherapy group

ACTIVE COMPARATOR

Non-skills-oriented interpersonal psychotherapy group

Behavioral: Interpersonal psychotherapy

Interventions

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 - emotion regulation skills training

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.

Dialectical behavior therapy - interpersonal effectiveness skills training

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.

Non-skills-oriented interpersonal psychotherapy group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Toledo: collaborator

Study Sites (1)

Psychological Services Center, University of Massachusetts Amherst

Amherst, Massachusetts, 01002, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder; Behavior

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Please note that initial results have not yet been peer-reviewed. As a pilot study conducted during COVID, this study was pivoted to offer telehealth during a time of social distancing. This likely increased amount of missing data for in-person assessed visits. Relatively low power for mixed effects models suggest alternative approaches to data analysis may need to be considered, but initial trial results are presented as originally proposed.

Results Point of Contact

• Title: Katherine Dixon-Gordon, PhD
• Organization: University of Massachusetts Amherst

katiedg@umass.edu

413-545-0226

Study Officials

• Katherine L Dixon-Gordon, PhD

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 12, 2020
• Study Start: October 26, 2020
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data are expected to be cleaned scored and uploaded by Jan 2024
• Access Criteria: Data will be available through NDA

Locations

US (1)