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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04773340
Other study ID # 957186
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date September 30, 2023

Study information

Verified date February 2021
Source Fordham University
Contact Barry Rosenfeld, PhD
Phone 718-817-3794
Email rosenfeld@fordham.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This pilot study is intended to adapt and refine an intervention grounded in the principles of Dialectical Behavior Therapy, for the treatment of repeat criminal offenders with antisocial personality disorder. This study will be open to individuals participating in an intensive supervision program operated by the U.S. District Court of the Southern District of New York (the RISE Court program).


Description:

Antisocial personality disorder (ASPD) is among the most damaging and costly mental disorders, yet little research has sought to address the root causes of this disorder. Indeed, many clinicians consider ASPD to be "untreatable", and have largely relegated the management of this challenging disorder to the criminal justice system, effectively relinquishing responsibility for understanding and treating ASPD. Although a number of interventions are utilized by the criminal justice system, these interventions have typically focused on specific problem behaviors, such as anger management and substance abuse. These interventions, along with the more broad-based approaches occasionally studied (e.g., criminal cognitions) focus primarily on cognitive processing, effectively ignoring core elements of ASPD such as impulsivity and emotion dysregulation. Recently, however, growing interest has centered on Dialectical Behavior Therapy as a potential intervention approach, particularly given the emphasis on tangible behaviors and the acquisition of skills to address the core elements of APSD. The proposed study builds upon an innovative rehabilitative program developed by the U.S. District Court in New York. Beginning in 2020, the Fordham Community Mental Health Clinic has provided a DBT-based intervention to participants in this rehabilitation program. This population is comprised of repeat criminal offenders who are deemed at high risk for reoffending by the Probation Department, the vast majority of whom meet diagnostic criteria for ASPD. This intervention, which builds on the researcher team's past work treating offenders with a history of stalking and intimate partner violence, has the potential to advance the utility of DBT for treatment of this challenging population. The present application proposes to advance this goal, by adapting DBT to target core symptoms of ASPD, including impulsivity, difficulties in emotional processing, and problem solving deficits. By adapting traditional DBT, this intervention hopes to demonstrate increased success in retaining and engaging this challenging population in treatment, decreasing the extent of problematic behaviors, and reducing the rates of violent and criminal reoffense. Most importantly, this application takes an experimental therapeutics approach, by identifying potential mediators of successful change in ASPD and quantifying the extent to which DBT impacts these traits and behaviors. Although DBT is not expected to "cure" ASPD, even modest improvements in the treatability of this challenging population would translate into substantial benefits given the high social, economic and health care costs associated with this disorder. Given these goals, the present application seeks to a) demonstrating the feasibility and acceptability of this intervention, b) reduce problematic character traits and behaviors (e.g., decreased impulsivity, increased emotion recognition), and c) reduce the rates of re-offending.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date September 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Over 18, English speaking, Participating in RISE Court program Exclusion Criteria: - Evidence of psychotic symptoms that would preclude meaningful participation in treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dialectical Behavior Therapy
Behaviorally-focused intervention for individuals with personality disorder and a history of significant behavioral problems.

Locations

Country Name City State
United States Fordham University Community Mental Health Clinic Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Fordham University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Completion of the treatment program Individuals will be classified as "completers" if they have finished the entire 16 week treatment program 4 months after initiation of treatment
Secondary Impulsivitity, Impulsivity will be measured with a self-report measure, the UPPS-P Impulsivity Scale, which will be administered prior to, and following completion of treatment Post-treatment (approximately 4 months after initiation of treatment)
Secondary Distress tolerance Distress tolerance will be measured with a self-report measure, the Distress Tolerance Scale, which will be administered prior to, and following completion of treatment Post-treatment (approximately 4 months after initiation of treatment)
Secondary Emotion regulation Distress tolerance will be measured with a self-report measure, the Difficulties in Emotion Regulation Scale, which will be administered prior to, and following completion of treatment Post-treatment (approximately 4 months after initiation of treatment)
Secondary Mindfulness Mindfulness will be measured with a self-report measure, the Mindful Attention Awareness Scale, which will be administered prior to, and following completion of treatment Post-treatment (approximately 4 months after initiation of treatment)
Secondary Renewed criminal charges following completion of treatment Participants will be monitored for at least one year following treatment in order to determine whether they have been charged with any additional criminal offenses 1 year
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