- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974553
Dialectical Behavior Therapy for Justice-Involved Veterans
Dialectical Behavior Therapy for Justice-Involved Veterans: A Randomized Clinical Trial
Study Overview
Status
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:
- 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.
- 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).
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emily R Edwards, PhD
- Phone Number: 3865 (718) 584-9000
- Email: emily.edwards5@va.gov
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
Contact:
- Ryan Holliday, PhD
- Email: ryan.holliday@va.gov
-
-
New York
-
Bronx, New York, United States, 10468-3904
- Recruiting
- James J. Peters VA Medical Center, Bronx, NY
-
Contact:
- Emily R Edwards, PhD
- Phone Number: 3865 718-584-9000
- Email: emily.edwards5@va.gov
-
Principal Investigator:
- Emily R Edwards, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dialectical Behavior Therapy for Justice-Involved Veterans
16 weeks of 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
|
Active Comparator: Supportive Group Psychotherapy
16 weeks of 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of Service / Case Management Inventory
Time Frame: Six times over course of 52 weeks
|
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
Time Frame: Six times over course of 52 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
suicide attempt
Time Frame: 52 weeks
|
self-reported or medical chart-documented suicide attempt
|
52 weeks
|
criminal recidivism
Time Frame: 52 weeks
|
new official record-documented arrest, violation, or order of protection filed
|
52 weeks
|
Beck Scale for Suicidal Ideation
Time Frame: Six times over course of 52 weeks
|
self-report instrument measuring nature, frequency, and intensity of suicidal ideation; score range = 0-38, with higher scores indicating greater severity of suicidal ideation
|
Six times over course of 52 weeks
|
The Measure of Criminogenic Thinking Styles
Time Frame: Three times over course of 52 weeks
|
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
|
Three times over course of 52 weeks
|
Patient Health Questionnaire-9
Time Frame: Six times over course of 52 weeks
|
self-report instrument measuring psychological distress; score range = 0-27, with higher scores indicating greater psychological distress
|
Six times over course of 52 weeks
|
Alcohol Use Disorders Identification Test
Time Frame: Six times over course of 52 weeks
|
self-report instrument measuring frequency and volume of alcohol use; score range = 0-40, with higher scores indicating more severe alcohol use
|
Six times over course of 52 weeks
|
Drug Abuse Screening Test
Time Frame: Six times over course of 52 weeks
|
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
|
Six times over course of 52 weeks
|
DBT-J Case Management Checklist
Time Frame: Six times over course of 52 weeks
|
self-report instrument measuring nature and severity of common case management difficulties; score range = 0-3, with higher scores indicating broader, more severe difficulties
|
Six times over course of 52 weeks
|
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time Frame: Six times over course of 52 weeks
|
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
|
Six times over course of 52 weeks
|
Connor-Davidson Resilience Scale
Time Frame: Six times over course of 52 weeks
|
self-report instrument measuring mental and emotional resilience; score range = 0-4, with higher scores indicating greater resilience
|
Six times over course of 52 weeks
|
Screen for Nonsuicidal Self Injury
Time Frame: Three times over course of 52 weeks
|
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
|
Three times over course of 52 weeks
|
Difficulties in Emotion Regulation Scale-18
Time Frame: Six times over course of 52 weeks
|
self-report instrument measuring difficulties in emotion regulation; score range = 18-90, with higher scores indicating greater difficulties in emotion regulation
|
Six times over course of 52 weeks
|
Triarchic Psychopathy Measure
Time Frame: Three times over course of 52 weeks
|
self-report instrument measuring personality traits commonly associated with psychopathy; score range = 0-3, with higher scores indicating more severe psychopathic personality traits
|
Three times over course of 52 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Emily R Edwards, PhD, James J. Peters Veterans Affairs Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D4566-R
- 1I01RX004566-01A1 (Other Grant/Funding Number: Department of Veterans Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Criminal Behavior
-
University of MichiganNational Center for Advancing Translational Sciences (NCATS)CompletedCriminal BehaviorUnited States
-
University of MichiganSIMmersion, LLCActive, not recruitingCriminal BehaviorUnited States
-
Iowa State UniversityEnrolling by invitationViolence | Criminal BehaviorUnited States
-
University of New MexicoActive, not recruitingChild Abuse | Parenting | Child Behavior | Child Development | Delinquency | Criminal Behavior | Child NeglectUnited States
-
The Mind Research NetworkRecruitingCriminal Behavior | Stimulant AbuseUnited States
-
Wetenschappelijk Onderzoek en DatacentrumLeiden University; Utrecht UniversityRecruitingDelinquency | Criminal Recidivism | Antisocial BehaviorNetherlands
-
Botec Analysis, LLCUnknownSubstance Abuse | Criminal BehaviorUnited States
-
Botec Analysis, LLCPennsylvania Department of Corrections; Bureau of Justice AssistanceUnknownSubstance Abuse | Criminal Behavior
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)Enrolling by invitationSubstance-Related Disorders | Opioid-Related Disorders | Substance Use | Recidivism | Criminal BehaviorUnited States
-
Karolinska InstitutetRecruitingSubstance Use Disorders | Criminal BehaviorSweden
Clinical Trials on Dialectical Behavior Therapy for Justice-Involved Veterans
-
VA Office of Research and DevelopmentCompleted
-
University Hospital, Strasbourg, FranceRecruitingEncephalitis | Meningitis | Acquired Brain Injury | Cerebral Anoxia | Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic) | Brain Tumor (After Recovery)France
-
Weill Medical College of Cornell UniversityCompleted
-
Pontificia Universidad Catolica de ChileUniversity Diego PortalesNot yet recruitingBorderline Personality DisorderChile
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedSuicide | Post-traumatic Stress Disorder | Self-injurious BehaviorUnited States
-
Haukeland University HospitalRecruitingSuicidal Ideation | Self-harm | Suicide and Self-harmNorway
-
Fordham UniversityNot yet recruitingAntisocial Personality DisorderUnited States
-
Rutgers, The State University of New JerseyActive, not recruitingBorderline Personality DisorderUnited States
-
University of ManitobaCompletedBorderline Personality DisorderCanada
-
Alexandria UniversityCompleted