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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03123198
Other study ID # Pro2019001864
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 2010
Est. completion date December 2025

Study information

Verified date April 2023
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dialectical Behavior Therapy
DBT is a multimodal comprehensive psychosocial treatment.

Locations

Country Name City State
United States Rutgers University Piscataway New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-Injurious Thoughts and Behaviors Interview Interview to assess prevalence rates of suicidal and self-injurious thoughts and behaviors Past six months
Primary Structured Clinical Interview for DSM-5 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 Difficulties in Emotion Regulation Scale Past two weeks
Secondary Borderline Symptom List (BSL-23) Past 1 month
Secondary Brief Symptom Inventory (BSI) Past 1 week
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