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Идёт набор NCT05974553

Dialectical Behavior Therapy for Justice-Involved Veterans

Без фазы С лечением Criminal Behavior Criminal Recidivism Psychosocial Functioning

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dialectical Behavior Therapy for Justice-Involved Veterans, Supportive Group Psychotherapy for Justice-Involved Veterans.
Кому может быть актуально
Состояния в реестре: Criminal Behavior, Criminal Recidivism, Psychosocial Functioning. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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
  • Поведенческое 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.

Первичные конечные точки

  • Level of Service / Case Management Inventory [Срок оценки: Six times over course of 52 weeks]
  • Inventory of Psychosocial Functioning [Срок оценки: Six times over course of 52 weeks]
Вторичные конечные точки (12)
  • Beck Scale for Suicidal Ideation [Срок оценки: Six times over course of 52 weeks]
  • The Measure of Criminogenic Thinking Styles [Срок оценки: Three times over course of 52 weeks]
  • Patient Health Questionnaire-9 [Срок оценки: Six times over course of 52 weeks]
  • Alcohol Use Disorders Identification Test [Срок оценки: Six times over course of 52 weeks]
  • Drug Abuse Screening Test [Срок оценки: Six times over course of 52 weeks]
  • DBT-J Case Management Checklist [Срок оценки: Six times over course of 52 weeks]
  • Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form [Срок оценки: Six times over course of 52 weeks]
  • Connor-Davidson Resilience Scale [Срок оценки: Six times over course of 52 weeks]
  • suicide attempt [Срок оценки: 52 weeks]
  • criminal recidivism [Срок оценки: 52 weeks]
  • Screen for Nonsuicidal Self Injury [Срок оценки: Three times over course of 52 weeks]
  • Difficulties in Emotion Regulation Scale-18 [Срок оценки: Six times over course of 52 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
  • James J. Peters VA Medical Center, Bronx, NY — The Bronx

Публикации

  • 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. On PMID 42343438

Идентификаторы

NCT: NCT05974553 · D4566-R · 1I01RX004566-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗