Dialectical Behavior Therapy for Justice-Involved Veterans

NCT ID: NCT05974553

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-12-31

Brief Summary

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Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J) is a comprehensive, integrative program distinctively designed to address the range of mental health, substance use, case management, and legal needs of Veterans with current or ongoing criminal justice involvement. Data from two prior clinical trials attest to the program's feasibility and acceptability and preliminarily suggest participation in the program may yield meaningful improvements in risk for criminal behavior and resolution of high-priority case management needs. However, continued research is needed to further investigate the program's efficacy. This Phase III clinical trial aims to investigate the superiority of DBT-J over a supportive group therapy treatment in decreasing risk of future criminal behavior and increasing psychosocial functioning. Secondary and exploratory aims will also investigate superiority of DBT-J in improving secondary treatment targets, potential differential efficacy across special-interest Veteran subgroups, and long-term consequences of program participation.

Detailed Description

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Despite substantial efforts to curb Veteran suicide, Veterans continue to die by suicide at rates that far exceed their civilian peers. To date, substantial resources have been invested into understanding and treating underlying risk factors and precipitants of Veteran suicide. However, criminal justice involvement remains an under-examined and under-assessed risk factor for Veteran suicide. Accumulating research suggests justice-involved Veterans are a high-risk, high need population, particularly within the Veterans Health Administration. For example, 11% of Veteran suicides are precipitated by legal troubles; 79% of Veterans receiving VA supportive housing assistance have a history of one or more arrests; and 58% of Veterans receiving outpatient VHA substance use treatment have a history of three or more arrests. Risk for suicide among justice-involved Veterans is particularly elevated among those with co-occurring difficulties, such as mental health concerns and/or housing instability. Adequately addressing Veteran suicide - both for justice-involved Veterans and the broader Veteran population - therefore likely requires interventions to address the legal and co-occurring difficulties of at-risk Veterans.

Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J) is distinctively designed to address these range of needs faced by justice-involved Veterans, including heightened suicide risk, antisocial behaviors, mental health and substance use concerns, community-based structural barriers, and case management difficulties. Combining elements of three prominent, evidence-based models, DBT-J provides 16 weeks of group psychotherapy, case management services, and measurement-based care to Veterans with ongoing or recent criminal justice involvement. Data from two prior clinical trials attest to the feasibility and acceptability of DBT-J within VHA behavioral health settings. Although preliminary, data also suggest participation in DBT-J may yield meaningful reductions in risk for future criminal behavior and resolution of high-priority case management needs. Continued research, however, is needed to further investigate the program's efficacy.

Toward these aims, this Phase III clinical trial will:

1. Primary Aims 1-2: Assess the superiority of DBT-J over supportive group therapy in decreasing risk of future criminal behavior and increasing psychosocial functioning.
2. Secondary Aim: Assess the superiority of DBT-J over supportive group therapy in improving secondary treatment targets (i.e., suicidal ideation, criminogenic thinking, psychological distress, substance use, case management needs, quality of life, resilience, suicide-related behavior, and criminal recidivism).
3. Exploratory Aims 1-2: Assess for differential efficacy of DBT-J across high-priority JIV subgroups (i.e., violent versus nonviolent most recent offense type, presence/absence of a substance use disorder, and presence/absence of a severe mental illness); assess long-term impact of DBT-J participation (versus participation in supportive group therapy) on primary and secondary treatment targets.

A total of 200 Veterans with current or recent involvement in the criminal justice system will be recruited from the greater New York City, New York and Denver, Colorado areas to participate in this clinical trial. Veterans will be randomly assigned to receive either 16 weeks of DBT-J or 16 weeks of supportive group therapy followed by a 36 week observational period. Comprehensive assessments of Veteran risk for future criminal justice involvement, psychosocial functioning, suicidal ideation, criminogenic thinking, psychological distress, substance use, case management needs, quality of life, resilience, suicide-related behavior, and criminal recidivism will be administered periodically throughout study completion. Analyses of variance will then be used to compare study conditions on primary and secondary treatment targets and to compare high-priority participant subgroups on primary and secondary treatment targets.

Conditions

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Criminal Behavior Criminal Recidivism Psychosocial Functioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multisite clinical trial with parallel experimental design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
All outcomes assessors are blind to participant study condition. Participants, study providers, and investigators will not be blind to study condition.

Study Groups

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Dialectical Behavior Therapy for Justice-Involved Veterans

16 weeks of Dialectical Behavior Therapy for Justice-Involved Veterans

Group Type EXPERIMENTAL

Dialectical Behavior Therapy for Justice-Involved Veterans

Intervention Type BEHAVIORAL

16 weeks of Dialectical Behavior Therapy for Justice-Involved Veterans, including weekly 60-minute group therapy and biweekly 30-minute individual case management

Supportive Group Psychotherapy

16 weeks of supportive group psychotherapy for justice-involved Veterans

Group Type ACTIVE_COMPARATOR

Supportive Group Psychotherapy for Justice-Involved Veterans

Intervention Type BEHAVIORAL

16 weeks of clinician-facilitated supportive group psychotherapy for justice-involved Veterans, including weekly 75-minute group psychotherapy (20 hours total intervention). All interventions delivered via telehealth.

Interventions

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Dialectical Behavior Therapy for Justice-Involved Veterans

16 weeks of Dialectical Behavior Therapy for Justice-Involved Veterans, including weekly 60-minute group therapy and biweekly 30-minute individual case management

Intervention Type BEHAVIORAL

Supportive Group Psychotherapy for Justice-Involved Veterans

16 weeks of clinician-facilitated supportive group psychotherapy for justice-involved Veterans, including weekly 75-minute group psychotherapy (20 hours total intervention). All interventions delivered via telehealth.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Veteran aged 18+
* Able to provide consent
* Current or recent history of criminal justice involvement, defined as

* (a) criminal arrest, order of protection, or incarceration within two years prior to participation and/or
* (b) supervision by probation or parole at the time of participation

Exclusion Criteria

* Limited English proficiency
* Inability to tolerate group therapy format
* Enrollment in a concurrent clinical trial
* Current or scheduled enrollment in a DBT- or RNR-based program
* Prior participation in DBT-J program
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily R Edwards, PhD

Role: PRINCIPAL_INVESTIGATOR

James J. Peters Veterans Affairs Medical Center

Locations

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Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Site Status RECRUITING

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily R Edwards, PhD

Role: CONTACT

(718) 584-9000 ext. 3865

Sharon Alter, MA

Role: CONTACT

(718) 584-9000 ext. 3696

Facility Contacts

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Ryan Holliday, PhD

Role: primary

Marianne S Goodman, MD

Role: primary

718-584-9000 ext. 5188

Angela Abreu

Role: backup

(718) 584-9000 ext. 6028

Other Identifiers

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1I01RX004566-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D4566-R

Identifier Type: -

Identifier Source: org_study_id

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