NCT05974553

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jan 2024Dec 2027

First Submitted

Initial submission to the registry

July 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

3.5 years

First QC Date

July 26, 2023

Last Update Submit

November 18, 2025

Conditions

Keywords

Criminal BehaviorCriminal RecidivismPsychosocial FunctioningPsychotherapyPsychotherapy, GroupCase ManagementPsychiatric Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Level of Service / Case Management Inventory

    semi-structured interview assessment of risk for future criminal justice involvement; score range = 0-43, with higher scores indicating greater risk for future criminal justice involvement

    Six times over course of 52 weeks

  • Inventory of Psychosocial Functioning

    self-report instrument measuring functional impairments in romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care; score range = 0-100, with higher scores indicating greater impairment in psychosocial functioning

    Six times over course of 52 weeks

Secondary Outcomes (13)

  • Beck Scale for Suicidal Ideation

    Six times over course of 52 weeks

  • The Measure of Criminogenic Thinking Styles

    Three times over course of 52 weeks

  • Patient Health Questionnaire-9

    Six times over course of 52 weeks

  • Alcohol Use Disorders Identification Test

    Six times over course of 52 weeks

  • Drug Abuse Screening Test

    Six times over course of 52 weeks

  • +8 more secondary outcomes

Study Arms (2)

Dialectical Behavior Therapy for Justice-Involved Veterans

EXPERIMENTAL

16 weeks of Dialectical Behavior Therapy for Justice-Involved Veterans

Behavioral: Dialectical Behavior Therapy for Justice-Involved Veterans

Supportive Group Psychotherapy

ACTIVE COMPARATOR

16 weeks of supportive group psychotherapy for justice-involved Veterans

Behavioral: Supportive Group Psychotherapy for Justice-Involved Veterans

Interventions

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

Dialectical Behavior Therapy 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.

Supportive Group Psychotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

RECRUITING

MeSH Terms

Conditions

Criminal BehaviorRecidivism

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Emily R Edwards, PhD

    James J. Peters Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily R Edwards, PhD

CONTACT

Sharon Alter, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All outcomes assessors are blind to participant study condition. Participants, study providers, and investigators will not be blind to study condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multisite clinical trial with parallel experimental design
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 3, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

To preserve participant confidentiality, individual participant data will not be shared with anyone outside of the immediate research team.

Locations