About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: FIT TAUActive comparator 1 intervention

Group B: FIT + IT-BAExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

2

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

3

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

4

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