NCT Number: NCT07744841
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: IT-BA
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 individual needs and goals. CHWs also assist with transportation to/from appointments and may provide smartphones with cellular and internet service to facilitate engagement in care. All FIT patients are also assigned a FIT primary care provider (with appointments coordinated by the CHW), and patients with opioid use disorder are offered an appointment with an MOUD provider. After initial coordination of care, CHWs maintain contact with FIT patients as needed to provide ongoing support
Other names: FIT, FIT TAU
Time frame: 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).
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
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)
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
Measured using the Client Satisfaction Questionnaire (CSQ-8). Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)
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.
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).
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.
Measured using the Patient Health Questionnaire 9 (PHQ-9 Depression). Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome)
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.
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).
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.
Measured using HIV Risk Behavior Scale (HRBS). Scale range 0-55, higher scores indicate greater HIV risk behavior (negative outcome).
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.
Measured using the Opioid Overdose Risk Behavior Scale, v.2 (ORBS-2). Scale range 0-30, higher scores indicate greater overdose risk behavior (negative outcome).
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.
Number of overdose events, via self-report. Higher number of overdose events is a negative outcome.
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.
Measured using the Contemplation Ladder for Drugs. Scale range 1-7, higher scores indicate greater readiness to change (positive outcome).
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.
Measured using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) - Taking Steps subscale. Scale range 8-40, higher scores indicate greater steps to change drug use (positive outcome)
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.
Measured using the DSM-5 Substance Use Symptom Checklist. Scale range 0-11, higher scores reflect greater number of SUD symptoms (negative outcome).
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.
Measured using the Behavioral Activation for Depression Scale (BADS). Scale range 0-150, higher scores indicate greater activation (positive outcome).
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.
Measured using the Environmental Reward Observation Scale (EROS); Scale range 10-40, higher scores indicate greater environmental reward (positive outcome).
Contact information is provided by the study sponsor or research team.
Catherine E. Paquette, PhD
Other
Individually Tailored Behavior Therapy for Post-Incarceration Drug Use in Reentry Primary Care
Acronym: STEPS
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