Antisocial Personality DisorderDBT-ASPDNCT04773340
Adapting Dialectical Behavior Therapy for the Treatment of Criminal Offenders With Antisocial Personality Disorder
An observational study of Antisocial Personality Disorder, run by Fordham University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antisocial Personality Disorder
- What is being tested?
- Dialectical Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Criminal offenders on probation in the Southern District of New York's intensive supervision program.
Who may be able to join
- Over 18, English speaking, Participating in RISE Court program
Who cannot join
- Evidence of psychotic symptoms that would preclude meaningful participation in treatment.
Trial locations and contacts
1 site in 1 country.
Michele Galietta, PhD contact
United States1 site
Fordham University Community Mental Health Clinic
The Bronx, New York, 104580000
BARRY ROSENFELD, PhD, 718-817-3794, ROSENFELD@FORDHAM.EDU
Christopher Conway, PhD, 718-817-0106, cconway26@fordham.edu
About this study
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).
Read the detailed 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.
- Conditions
- Antisocial Personality Disorder
- Being tested
- Dialectical Behavior Therapy
- Medical subject headings
- Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior TherapyBehavioural
Behaviorally-focused intervention for individuals with personality disorder and a history of significant behavioral problems.
| Study group | Role | What they receive |
|---|---|---|
| DBT intervention | Adaptation of Dialectical Behavior Therapy designed for repeat criminal offenders at high risk of reoffense. Receives: Behavioral: Dialectical Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the treatment program
Individuals will be classified as "completers" if they have finished the entire 16 week treatment program
Measured: 4 months after initiation of treatment
Secondary outcomes (5)
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
Measured: Post-treatment (approximately 4 months after initiation of treatment)
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
Measured: Post-treatment (approximately 4 months after initiation of treatment)
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
Measured: Post-treatment (approximately 4 months after initiation of treatment)
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
Measured: Post-treatment (approximately 4 months after initiation of treatment)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Oct 2021 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antisocial Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fordham University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry Rosenfeld, Fordham University
- Investigators
- Barry Rosenfeld, PhD, Principal investigator, Fordham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773340
- Sponsor's protocol ID
- 957186
- Acronym
- DBT-ASPD
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Because this is a pilot study it is unclear whether data will be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Dialectical Behavior Therapy for the Treatment of Criminal Offenders With Antisocial Personality Disorder
- ClinicalTrials.gov ID
- NCT04773340
- Acronym / sponsor ID
- DBT-ASPD / 957186
- Conditions
- Antisocial Personality Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fordham UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBT intervention | – | Behavioral: Dialectical Behavior TherapyAdaptation of Dialectical Behavior Therapy designed for repeat criminal offenders at high risk of reoffense. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Criminal offenders on probation in the Southern District of New York's intensive supervision program.
Key inclusion criteria (1 listed)
- Over 18, English speaking, Participating in RISE Court program
Key exclusion criteria (1 listed)
- Evidence of psychotic symptoms that would preclude meaningful participation in treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavior TherapyBehaviorally-focused intervention for individuals with personality disorder and a history of significant behavioral problems. | Behavioural | DBT intervention |
Primary outcome
Completion of the treatment program
Time frame: 4 months after initiation of treatment
Individuals will be classified as "completers" if they have finished the entire 16 week treatment program
5 secondary outcomes
Impulsivitity,
Time frame: Post-treatment (approximately 4 months after initiation of treatment)
Distress tolerance
Time frame: Post-treatment (approximately 4 months after initiation of treatment)
Emotion regulation
Time frame: Post-treatment (approximately 4 months after initiation of treatment)
Mindfulness
Time frame: Post-treatment (approximately 4 months after initiation of treatment)
Renewed criminal charges following completion of treatment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Undecided. Because this is a pilot study it is unclear whether data will be made available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Galietta, PhD contact
Barry Rosenfeld, PhD principal investigator
Fordham University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antisocial Personality Disorder, run by Fordham University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barry Rosenfeld, PhD (718-817-3794, rosenfeld@fordham.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of the treatment program (time frame: 4 months after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.