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Набор скоро начнётся NCT07744841

Supportive Treatment With Enhanced Post-Incarceration Services

Без фазы С лечением Substance Use Disorders (SUDs)

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: Individually Tailored Behavioral Activation, Formerly Incarcerated Transitions Program.
Кому может быть актуально
Состояния в реестре: Substance Use Disorders (SUDs). 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Individually Tailored Behavior Therapy for Post-Incarceration Drug Use in Reentry Primary Care

Обзор

This study aims to improve health outcomes for people who use drugs after release from incarceration, a period of high risk for overdose and other adverse outcomes. It will examine an individually tailored behavioral activation (IT-BA) intervention integrated into a reentry primary care program with peer support. The goal is to reduce substance use, improve mental health, and increase engagement in healthcare.

Подробное описание

People who use drugs (PWUD) often experience adverse outcomes in the year following release from incarceration, including overdose, suicide, and infectious disease acquisition. Depressive symptoms and illicit drug use are key mediators of these adverse outcomes, and risk is compounded by low health service engagement among PWUD. Yet empirically supported interventions that directly target these mechanisms among people with past-year incarceration are lacking. The proposed study addresses this gap.

Current models that integrate medical care with peer support can improve outcomes for formerly incarcerated people but do not adequately address mental health and drug use. The Formerly Incarcerated Transitions (FIT) program in North Carolina employs the Transitions Care Network (TCN) model of reentry primary care enhanced with peer support and linkage to care (including medication for opioid use disorder). Research on the TCN has demonstrated positive outcomes for individuals with recent incarceration, yet PWUD in these programs often continue to use drugs and have low engagement in behavioral health services. There is a need for integrated care models that incorporate tailored treatment approaches to engage more PWUD in treatment for mental and behavioral health after incarceration.

Individually Tailored Behavioral Activation (IT-BA) represents a promising intervention approach for PWUD that would complement integrated care models like the TCN. Behavioral Activation (BA) is an empirically supported intervention that is effective in treating both substance use disorder (SUD) and depression. IT-BA is an individually tailored, low-barrier version of BA that was adapted by Dr. Paquette and has demonstrated preliminary efficacy among PWUD. However, it has not yet been studied as part of integrated care models or among people with past-year incarceration, who experience the greatest risk of adverse health outcomes. This study will evaluate IT-BA as an adjunct to the FIT program for PWUD with recent incarceration. Combining IT-BA with enhanced reentry primary care will target multiple mechanisms contributing to post-release adverse outcomes among PWUD, including depressive symptoms, illicit drug use, and health service disengagement.

The overall goal of this research project is to evaluate an individually tailored behavioral intervention, combined with enhanced reentry primary care for drug use, to address the complex health and behavioral needs of PWUD experiencing recent incarceration.

Specific Aims:

* Aim 1: Identify barriers and facilitators to implementing individually tailored behavior therapy for drug use in a primary care setting. * Aim 2: Develop a protocol for integrating the IT-BA treatment with the FIT program using a community-engaged approach. * Aim 3: Test the feasibility, acceptability, and initial efficacy of IT-BA as an adjunct to the FIT enhanced reentry primary care program.

Вмешательства

  • Поведенческое Individually Tailored Behavioral Activation
    IT-BA is an individually tailored, low-barrier version of Behavioral Activation (BA) that was adapted by Dr. Paquette and has demonstrated preliminary efficacy among people who use drugs (PWUD). IT-BA will be delivered in 12 sessions over 8 weeks in a low-barrier, flexible hybrid format with the option of in-person and/or teletherapy appointments.
  • Поведенческое Formerly Incarcerated Transitions Program
    The FIT program provides integrated medical care enhanced with peer support and linkage to care for individuals who have been incarcerated within the past year and have at least one chronic health condition, including substance use disorders. After the intake assessment, which includes evaluation of medical and psychosocial needs, community health workers (CHWs) provide peer support and help connect patients to appropriate services at FIT clinic sites and in the community based on their individu

Первичные конечные точки

  • Treatment Attendance (Feasibility) [Срок оценки: During the intervention period, or up to 10 weeks after the pretreatment assessment, where average treatment duration is 8 weeks]
  • Therapeutic Alliance (Acceptability) [Срок оценки: At the posttreatment assessment (Time 2), which occurs after treatment completion or a maximum of 3 months after the baseline (Time 1) assessment]
  • Treatment Satisfaction (Acceptability) [Срок оценки: At the posttreatment assessment (Time 2), which occurs after treatment completion or a maximum of 3 months after the baseline (Time 1) assessment]
  • Substance use [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]
  • Depressive Symptoms [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]
  • Healthcare Engagement [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]
Вторичные конечные точки (8)
  • HIV risk behaviors [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]
  • Opioid overdose risk behavior [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]
  • Overdose events [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]
  • Readiness to change drug use [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]
  • Steps to change drug use [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]
  • DSM-5 SUD symptoms [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]
  • Behavioral activation [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]
  • Environmental Reward [Срок оценки: Baseline (Time 1; month 0), posttreatment (Time 2; month 2), 1-month follow-up (Time 3; month 3), 3-month follow-up (Time 4; month 5), and 6-month follow-up (Time 5; month 8). Post-baseline assessments may occur within a 1-month window.]

Критерии участия

Критерии включения

  • Be aged 18 years or older
  • Have recent illicit drug use, defined as use of any illegal drug in the past week
  • Meet DSM-5 criteria for a current (past 12 months) substance use disorder associated with any illegal drug
  • Have been released from jail or prison (at least 30 consecutive days incarcerated) within the past year

Критерии исключения

  • Currently engaged in psychosocial treatment for drug use
  • Unable to speak and understand English
  • Unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate (e.g., dementia)

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
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07744841 · Pro00120118 · 1K23DA063795-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗