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Dialectical Behavior Therapy Rutgers University Research Program (DBT-RU)

Primary Purpose

Borderline Personality Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical Behavior Therapy
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring borderline personality disorder, suicidal behaviors, dialectical behavior therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A. Age 18 years or older. B. Agreement to take part in assessments, videotaping/audiotaping and coding of their sessions by research personnel.

C. Agreement to pay for mental health services at the DBT-RU, and to participate in research assessments as volunteers.

D. Residence within commuting distance of clinic (< 45 minutes) E. Agreement to discontinue other forms of therapy F. Meets criteria for borderline personality disorder (BPD)

Exclusion Criteria:

  • A. Clients who need mental health services not available at the DBT-RU, such as treatment for schizophrenia or life-threatening anorexia, or who are currently obtaining optimum professional treatment that should not be ended.

B. Non-English speaking. C. Present DSM-IV diagnosis of Mental Retardation. D. Unable to understand research consent forms.

Sites / Locations

  • Rutgers University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dialectical Behavior Therapy

Arm Description

All participants receive six months of standard DBT which includes individual therapy, skills training, and as-needed phone consultation.

Outcomes

Primary Outcome Measures

Self-Injurious Thoughts and Behaviors Interview
Interview to assess prevalence rates of suicidal and self-injurious thoughts and behaviors
Structured Clinical Interview for DSM-5
Interview to assess lifetime and current rates of psychological disorders

Secondary Outcome Measures

Difficulties in Emotion Regulation Scale
Borderline Symptom List (BSL-23)
Brief Symptom Inventory (BSI)

Full Information

First Posted
April 18, 2017
Last Updated
April 14, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT03123198
Brief Title
Dialectical Behavior Therapy Rutgers University Research Program
Acronym
DBT-RU
Official Title
Dialectical Behavior Therapy Rutgers University Research Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2010 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This protocol establishes a research oriented psychological treatment clinic within the Graduate School of Applied and Professional Psychology (GSAPP), called the Dialectical Behavior Therapy Rutgers University Research Program (DBT-RU). The overall aim of the proposed research is to find ways to improve therapist training in existing treatments for complex and difficult-to-treat problems (e.g., DBT, prolonged exposure), develop new and more effective treatments, and improve understanding of severe psychopathology. Consequently, this proposed research will have four branches: (1) training of research clinicians and evaluation of training methods; (2) training of clinical evaluators for the research studies and evaluation of assessment training methods; (3) assessment of treatment outcome, including assessment of mediators and moderators of change (both clinician and client data); (4) assessment and analyses of psychopathology of subject populations who participate in the DBT-RU.
Detailed Description
DBT is an evidence-based and empirically supported treatment for borderline personality disorder (BPD), suicide, and self-injury. DBT is traditionally administered for a minimum of 6 months in an outpatient setting but has been adapted to be used in other treatment settings (e.g., intensive outpatient). DBT consists of multiple key components, including weekly individual therapy, group skills training, and option to engage in out-of-session contact with their provider via telephone to receive coaching on how to use DBT skills to manage real-life issues (e.g., urges to harm self). To date, more than a dozen randomized control trials (RCTs) and quasi-experimental studies have been conducted, and compared to 12 months of treatment as usual (TAU), DBT has been shown to result in significantly greater reduction in frequency and severity of self-injurious behaviors, inpatient hospitalizations, suicidal ideation, and substance abuse (see Panos, Jackson, Hasan, & Panos, 2014 ). This research aims to (1) advance our understanding of underlying mechanisms driving treatment outcomes; (2) isolate the effects of particular components and strategies employed in DBT on various outcomes (e.g., suicide), (3) enhance training and evaluation methods for research clinicians; (4) test to see if benefits in DBT are sustained over a period of time beyond follow-up; and (5) advance our knowledge of how DBT operates in everyday life to reduce day-to-day emotion dysregulation and related target behaviors (e.g., suicidal behavior).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
borderline personality disorder, suicidal behaviors, dialectical behavior therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dialectical Behavior Therapy
Arm Type
Experimental
Arm Description
All participants receive six months of standard DBT which includes individual therapy, skills training, and as-needed phone consultation.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy
Intervention Description
DBT is a multimodal comprehensive psychosocial treatment.
Primary Outcome Measure Information:
Title
Self-Injurious Thoughts and Behaviors Interview
Description
Interview to assess prevalence rates of suicidal and self-injurious thoughts and behaviors
Time Frame
Past six months
Title
Structured Clinical Interview for DSM-5
Description
Interview to assess lifetime and current rates of psychological disorders
Time Frame
At baseline, lifetime history is assessed. At 3-months and 6-months, changes to diagnostic status are assessed.
Secondary Outcome Measure Information:
Title
Difficulties in Emotion Regulation Scale
Time Frame
Past two weeks
Title
Borderline Symptom List (BSL-23)
Time Frame
Past 1 month
Title
Brief Symptom Inventory (BSI)
Time Frame
Past 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A. Age 18 years or older. B. Agreement to take part in assessments, videotaping/audiotaping and coding of their sessions by research personnel. C. Agreement to pay for mental health services at the DBT-RU, and to participate in research assessments as volunteers. D. Residence within commuting distance of clinic (< 45 minutes) E. Agreement to discontinue other forms of therapy F. Meets criteria for borderline personality disorder (BPD) Exclusion Criteria: A. Clients who need mental health services not available at the DBT-RU, such as treatment for schizophrenia or life-threatening anorexia, or who are currently obtaining optimum professional treatment that should not be ended. B. Non-English speaking. C. Present DSM-IV diagnosis of Mental Retardation. D. Unable to understand research consent forms.
Facility Information:
Facility Name
Rutgers University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33051036
Citation
Fitzpatrick S, Bailey K, Rizvi SL. Changes in Emotions Over the Course of Dialectical Behavior Therapy and the Moderating Role of Depression, Anxiety, and Posttraumatic Stress Disorder. Behav Ther. 2020 Nov;51(6):946-957. doi: 10.1016/j.beth.2019.12.009. Epub 2019 Dec 30.
Results Reference
derived

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Dialectical Behavior Therapy Rutgers University Research Program

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