AzTrials
AzTrials

Criminal BehaviorNCT05974553

Dialectical Behavior Therapy for Justice-Involved Veterans

A study testing Dialectical Behavior Therapy for Justice-Involved Veterans and Supportive Group Psychotherapy for Justice-Involved Veterans in people with Criminal Behavior and Criminal Recidivism, run by VA Office of Research and Development at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dialectical Behavior Therapy for Justice-Involved Veterans and Supportive Group Psychotherapy for Justice-Involved Veterans
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
2 sitesUnited States
Study dates
1 Jan 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Veteran
  • 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

Who cannot join

  • 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 Dialectical Behavior Therapy for Justice-Involved Veterans (DBT-J) program

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

  • James J. Peters VA Medical Center, Bronx, NY

    The Bronx, New York, 10468-3904

Other trials in United States

About this study

Official title: Dialectical Behavior Therapy for Justice-Involved Veterans: A Randomized Clinical Trial

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.

Read the detailed description

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.

Up to 250 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.

Being tested
Dialectical Behavior Therapy for Justice-Involved Veterans, Supportive Group Psychotherapy for Justice-Involved Veterans
Keywords
Criminal Behavior, Criminal Recidivism, Psychosocial Functioning, Psychotherapy, Psychotherapy, Group, Case Management, Psychiatric Rehabilitation
Medical subject headings
Criminal Behavior, Recidivism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialectical Behavior Therapy for Justice-Involved VeteransBehavioural

    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 for Justice-Involved VeteransBehavioural

    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.

Study groups in NCT05974553
Study groupRoleWhat they receive
Dialectical Behavior Therapy for Justice-Involved VeteransExperimental16 weeks of Dialectical Behavior Therapy for Justice-Involved Veterans
Receives: Behavioral: Dialectical Behavior Therapy for Justice-Involved Veterans
Supportive Group PsychotherapyActive comparator16 weeks of supportive group psychotherapy for justice-involved Veterans
Receives: Behavioral: Supportive Group Psychotherapy for Justice-Involved Veterans

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Six times over course of 52 weeks

  2. 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

    Measured: Six times over course of 52 weeks

Secondary outcomes (13)
  1. Beck Scale for Suicidal Ideation

    self-report instrument measuring nature, frequency, and intensity of suicidal ideation; score range = 0-38, with higher scores indicating greater severity of suicidal ideation

    Measured: Six times over course of 52 weeks

  2. The Measure of Criminogenic Thinking Styles

    self-report instrument measuring tendency to adopt thinking styles commonly associated with engagement in criminal behavior; score range = 65-325, with higher scores indicating greater tendency to engage in criminogenic thinking styles

    Measured: Three times over course of 52 weeks

  3. Patient Health Questionnaire-9

    self-report instrument measuring psychological distress; score range = 0-27, with higher scores indicating greater psychological distress

    Measured: Six times over course of 52 weeks

  4. Alcohol Use Disorders Identification Test

    self-report instrument measuring frequency and volume of alcohol use; score range = 0-40, with higher scores indicating more severe alcohol use

    Measured: Six times over course of 52 weeks

  5. Drug Abuse Screening Test

    self-report instrument measuring frequency and volume of non-alcohol related substance use; score range = 0-10, with higher scores indicating more severe drug use

    Measured: Six times over course of 52 weeks

  6. DBT-J Case Management Checklist

    self-report instrument measuring nature and severity of common case management difficulties; score range = 0-3, with higher scores indicating broader, more severe difficulties

    Measured: Six times over course of 52 weeks

  7. Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

    self-report instrument measuring quality of life and perceived satisfaction with life circumstances; score range = 16-80, with higher scores indicating greater perceived satisfaction with life circumstances

    Measured: Six times over course of 52 weeks

  8. Connor-Davidson Resilience Scale

    self-report instrument measuring mental and emotional resilience; score range = 0-4, with higher scores indicating greater resilience

    Measured: Six times over course of 52 weeks

  9. Suicide attempt

    self-reported or medical chart-documented suicide attempt

    Measured: 52 weeks

  10. Criminal recidivism

    new official record-documented arrest, violation, or order of protection filed

    Measured: 52 weeks

  11. Screen for Nonsuicidal Self Injury

    self-report instrument measuring nature and frequency of nonsuicidal self-injury; score range = 0-50, with higher scores indicating greater variation in and frequency of nonsuicidal self-injury

    Measured: Three times over course of 52 weeks

  12. Difficulties in Emotion Regulation Scale-18

    self-report instrument measuring difficulties in emotion regulation; score range = 18-90, with higher scores indicating greater difficulties in emotion regulation

    Measured: Six times over course of 52 weeks

  13. Triarchic Psychopathy Measure

    self-report instrument measuring personality traits commonly associated with psychopathy; score range = 0-3, with higher scores indicating more severe psychopathic personality traits

    Measured: Three times over course of 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start1 Jan 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multisite clinical trial with parallel experimental design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05974553
Sponsor's protocol ID
D4566-R
Other IDs
1I01RX004566-01A1
Status last verified
Oct 2026
First submitted
26 Jul 2023
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To preserve participant confidentiality, individual participant data will not be shared with anyone outside of the immediate research team.

Publications

  • Edwards ER, Holliday R, Alter S, Blonigen D, Decker SE, Dichiara A, Epshteyn G, Forster J, Fortuna AJ, Galietta M, Kimbrel NA, Stimmel M, Thomas S, Tsai J, Goodman M. Dialectical behavior therapy for justice-involved veterans: randomized clinical trial protocol comparing treatment approaches for veterans with criminal-legal involvement. BMC Psychol. 2026 Jun 24. doi: 10.1186/s40359-026-04749-2. Online ahead of print.

    PubMed 42343438

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behavior Therapy for Justice-Involved Veterans and Supportive Group Psychotherapy for Justice-Involved Veterans in people with Criminal Behavior and Criminal Recidivism, run by VA Office of Research and Development at 2 sites 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of Service / Case Management Inventory (time frame: Six times over course of 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05974553, which also lists 1 linked publication.

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 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in