Supportive Treatment With Enhanced Post-Incarceration Services
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Individually Tailored Behavioral Activation, Formerly Incarcerated Transitions Program.
- Who it may be relevant to
- Registry conditions: Substance Use Disorders (SUDs). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Individually Tailored Behavior Therapy for Post-Incarceration Drug Use in Reentry Primary Care
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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. - Behavioral 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
Primary outcome measures
- Treatment Attendance (Feasibility) [Time frame: During the intervention period, or up to 10 weeks after the pretreatment assessment, where average treatment duration is 8 weeks]
- Therapeutic Alliance (Acceptability) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]
Secondary outcome measures (8)
- HIV risk behaviors [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07744841 · Pro00120118 · 1K23DA063795-01