An interventional study of Individually Tailored Behavioral Activation and Formerly Incarcerated Transitions Program in Substance Use Disorders (SUDs), sponsored by Catherine E. Paquette, PhD. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Catherine E. Paquette, PhD · Not applicable, Interventional, and Health services research
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.
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:
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 120 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →This is the only study on the registry with Catherine E. Paquette, PhD as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Formerly Incarcerated Transitions (FIT) program engagement treatment-as-usual (TAU). As part of the FIT program, all participants will be linked with a community health worker with lived experience of incarceration who provides peer support and coordinates care. All participants will also receive referrals to behavioral health services in the community.
Behavioral: Formerly Incarcerated Transitions Program
Formerly Incarcerated Transitions (FIT) program engagement with an Individually Tailored Behavioral Activation (IT-BA) intervention. As part of the FIT program, all participants will be linked with a community health worker with lived experience of incarceration who provides peer support and coordinates care. 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. All participants will also receive referrals to behavioral health services in the community.
Behavioral: Individually Tailored Behavioral Activation · Behavioral: Formerly Incarcerated Transitions Program
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.
Also known as: 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
Also known as: FIT, FIT TAU
Treatment Attendance (Feasibility)
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: During the intervention period, or up to 10 weeks after the pretreatment assessment, where average treatment duration is 8 weeks
Therapeutic Alliance (Acceptability)
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
Treatment Satisfaction (Acceptability)
Measured using the Client Satisfaction Questionnaire (CSQ-8). Scale range 8 to 32, higher scores indicate greater satisfaction (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
Substance use
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.
Depressive Symptoms
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.
Healthcare Engagement
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.
HIV risk behaviors
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.
Opioid overdose risk behavior
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.
Overdose events
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.
Readiness to change drug use
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.
Steps to change drug use
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.
DSM-5 SUD symptoms
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.
Behavioral activation
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.
Environmental Reward
Measured using the Environmental Reward Observation Scale (EROS); Scale range 10-40, higher scores indicate greater environmental reward (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.
No study locations are listed for this record.
Plan to share: Yes — De-identified study data will be stored long-term in the Duke Research Data Repository following the completion of the study. This repository requires researchers to formally apply to use the data and obtain approval prior to gaining access.
Data sharing details ↗ · research.repository.duke.edu
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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