Clinical trial NCT05974553: Dialectical Behavior Therapy for Justice-Involved Veterans
Official title: Dialectical Behavior Therapy for Justice-Involved Veterans: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Criminal Behavior
Criminal Recidivism
Psychosocial Functioning
Keywords: Criminal Behavior
Criminal Recidivism
Psychosocial Functioning
Psychotherapy
Psychotherapy, Group
Case Management
Psychiatric Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-08-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multisite clinical trial with parallel experimental design
Primary purpose: TREATMENT

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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of Service / Case Management Inventory
timeFrame: Six times over course of 52 weeks
measure: Inventory of Psychosocial Functioning
timeFrame: Six times over course of 52 weeks
Secondary outcomes:
measure: Beck Scale for Suicidal Ideation
timeFrame: Six times over course of 52 weeks
measure: The Measure of Criminogenic Thinking Styles
timeFrame: Three times over course of 52 weeks
measure: Patient Health Questionnaire-9
timeFrame: Six times over course of 52 weeks
measure: Alcohol Use Disorders Identification Test
timeFrame: Six times over course of 52 weeks
measure: Drug Abuse Screening Test
timeFrame: Six times over course of 52 weeks
measure: DBT-J Case Management Checklist
timeFrame: Six times over course of 52 weeks
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: Six times over course of 52 weeks
measure: Connor-Davidson Resilience Scale
timeFrame: Six times over course of 52 weeks
measure: suicide attempt
timeFrame: 52 weeks
measure: criminal recidivism
timeFrame: 52 weeks
measure: Screen for Nonsuicidal Self Injury
timeFrame: Three times over course of 52 weeks
measure: Difficulties in Emotion Regulation Scale-18
timeFrame: Six times over course of 52 weeks
measure: Triarchic Psychopathy Measure
timeFrame: Three times over course of 52 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
Study officials:
affiliation: James J. Peters Veterans Affairs Medical Center
name: Emily R Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References: