Individually Tailored Behavior Therapy for Post-Incarceration Drug Use in Reentry Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Treatment Attendance (Feasibility)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Treatment Attendance (Feasibility)
时间窗: During the intervention period, or up to 10 weeks after the pretreatment assessment, where average treatment duration is 8 weeks
Assessed via attendance at IT-BA treatment sessions, with primary outcomes being treatment uptake (attending ≥1 session) and adherence (attending ≥6 of 12 sessions). Range 0-12 sessions; Higher number indicates greater attendance (positive outcome).
Therapeutic Alliance (Acceptability)
时间窗: At the posttreatment assessment (Time 2), which occurs after treatment completion or a maximum of 3 months after the baseline (Time 1) assessment
Measured using the Working Alliance Inventory - Short Form, Revised (WAI-SR). Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)
Treatment Satisfaction (Acceptability)
时间窗: At the posttreatment assessment (Time 2), which occurs after treatment completion or a maximum of 3 months after the baseline (Time 1) assessment
Measured using the Client Satisfaction Questionnaire (CSQ-8). Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)
Substance use
时间窗: 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.
Measured using the Timeline Follow-Back (TLFB) interview, which assesses frequency and quantity of substance use via calendar-based, semi-structured interview. Higher scores indicate greater substance use frequency or quantity (negative outcome).
Depressive Symptoms
时间窗: 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.
Measured using the Patient Health Questionnaire 9 (PHQ-9 Depression). Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome)
Healthcare Engagement
时间窗: 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.
Defined as the total number of outpatient visits during the assessment period, including primary care, medications for opioid use disorder (MOUD), and behavioral health services. Data sources: self-report; confirmed via electronic health records (EHR). Higher number indicates greater healthcare engagement (positive outcome).
次要结局
- HIV risk behaviors(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(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(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(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(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(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(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(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.)
研究者
Catherine E. Paquette, PhD
Assistant Professor, Dept of Population Health Sciences
Duke University