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

July 29, 2024 updated by: Shireen L. Rizvi, PhD, ABPP, Rutgers, The State University of New Jersey
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Rutgers University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-Injurious Thoughts and Behaviors Interview
Time Frame: Past six months
Interview to assess prevalence rates of suicidal and self-injurious thoughts and behaviors
Past six months
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
At baseline, lifetime history is assessed. At 3-months and 6-months, changes to diagnostic status are assessed.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Difficulties in Emotion Regulation Scale
Time Frame: Past two weeks
Past two weeks
Borderline Symptom List (BSL-23)
Time Frame: Past 1 month
Past 1 month
Brief Symptom Inventory (BSI)
Time Frame: Past 1 week
Past 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2019001864

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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