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

• ClinicalTrials.gov Identifier: NCT03123198
• Recruitment Status: Active, not recruiting
• First Posted: April 21, 2017
• Last Update Posted: April 18, 2023
• Sponsor: Rutgers, The State University of New Jersey
• Information provided by (Responsible Party): Shireen L. Rizvi, PhD, ABPP, Rutgers, The State University of New Jersey

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.

Condition or disease	Intervention/treatment	Phase
Borderline Personality Disorder	Behavioral: Dialectical Behavior Therapy	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dialectical Behavior Therapy Rutgers University Research Program
• Actual Study Start Date: March 2010
• Estimated Primary Completion Date: March 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dialectical Behavior Therapy; All participants receive six months of standard DBT which includes individual therapy, skills training, and as-needed phone consultation.	Behavioral: Dialectical Behavior Therapy; DBT is a multimodal comprehensive psychosocial treatment.

Outcome Measures

Primary Outcome Measures :

1. Self-Injurious Thoughts and Behaviors Interview [ Time Frame: Past six months ]
   Interview to assess prevalence rates of suicidal and self-injurious thoughts and behaviors
2. Structured Clinical Interview for DSM-5 [ Time Frame: At baseline, lifetime history is assessed. At 3-months and 6-months, changes to diagnostic status are assessed. ]
   Interview to assess lifetime and current rates of psychological disorders

Secondary Outcome Measures :

1. Difficulties in Emotion Regulation Scale [ Time Frame: Past two weeks ]
2. Borderline Symptom List (BSL-23) [ Time Frame: Past 1 month ]
3. Brief Symptom Inventory (BSI) [ Time Frame: Past 1 week ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New Jersey

Rutgers University

Piscataway, New Jersey, United States, 08854

Sponsors and Collaborators

Rutgers, The State University of New Jersey

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Shireen L. Rizvi, PhD, ABPP, Associate Professor of Clinical Psychology, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT03123198
• Other Study ID Numbers: Pro2019001864
• First Posted: April 21, 2017
• Last Update Posted: April 18, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shireen L. Rizvi, PhD, ABPP, Rutgers, The State University of New Jersey:

borderline personality disorder; suicidal behaviors; dialectical behavior therapy

Additional relevant MeSH terms:

Personality Disorders; Borderline Personality Disorder; Mental Disorders