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临床试验/NCT05974553
NCT05974553招募中不适用

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

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
4
主要终点
Level of Service / Case Management Inventory

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Level of Service / Case Management Inventory

时间窗: 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

Inventory of Psychosocial Functioning

时间窗: 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

次要结局

  • Beck Scale for Suicidal Ideation(Six times over course of 52 weeks)
  • Patient Health Questionnaire-9(Six times over course of 52 weeks)
  • Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form(Six times over course of 52 weeks)
  • Connor-Davidson Resilience Scale(Six times over course of 52 weeks)
  • The Measure of Criminogenic Thinking Styles(Three times over course of 52 weeks)
  • suicide attempt(52 weeks)
  • Screen for Nonsuicidal Self Injury(Three times over course of 52 weeks)
  • Difficulties in Emotion Regulation Scale-18(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)
  • DBT-J Case Management Checklist(Six times over course of 52 weeks)
  • criminal recidivism(52 weeks)
  • Triarchic Psychopathy Measure(Three times over course of 52 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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