Supportive Treatment With Enhanced Post-Incarceration Services

NCT07744841 | Not Yet Recruiting

• 2 other identifiers: Pro001201181K23DA063795-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Substance Use Disorders (SUDs)

Keywords

Incarceration; Reentry; Peer Support; Addiction; Drug Use; Primary Care; Community Health Workers; Behavioral Activation; Behavior Therapy

Outcome Measures

Primary Outcomes (6)

• 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).

  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)

  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)

  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).

  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)

  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).

  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 Outcomes (8)

• 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.

Study Arms (2)

FIT TAU

ACTIVE COMPARATOR

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

FIT + IT-BA

EXPERIMENTAL

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

Interventions

Individually Tailored Behavioral Activation BEHAVIORAL

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

FIT + IT-BA

Formerly Incarcerated Transitions Program BEHAVIORAL

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

FIT + IT-BA; FIT TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Catherine E. Paquette, PhD: lead
• National Institute on Drug Abuse (NIDA): collaborator

Related Links

• NC Formerly Incarcerated Transition Program

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Central Study Contacts

Catherine Paquette, PhD

CONTACT

+1 919-681-6801; catherine.paquette@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Dept of Population Health Sciences

Model Details: Adults with current substance use disorders (SUDs) who have been incarcerated in the past year will be recruited from community-based settings and randomly assigned in equal distribution to one of two arms: 1) Formerly Incarcerated Transitions (FIT) program engagement treatment-as-usual (TAU); or 2) FIT program engagement + 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.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share