Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence (HEAL Together)

July 5, 2023 updated by: University of Maryland, College Park

Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MT Among Low-Income, Minority Individuals With OUD

The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minority individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT), we will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over six months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The opioid use disorder (OUD) crisis disproportionately affects low-income, racial/ethnic minorities. There is a pressing need to improve retention in medication for opioid use disorder (MOUD), particularly among low-income, racial/ethnic minorities. Training peer recovery specialists (PRSs), individuals with their own lived experience with substance use disorder (SUD), in evidence-based interventions (EBIs) may be a promising strategy to improve MOUD retention for low-income, minority individuals with OUD. Yet, few EBIs have been evaluated for PRS delivery to promote MOUD retention.

Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving MOUD retention for low-income, minority individuals with OUD. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, and improving medication adherence (i.e., for HIV) among low-income, minority populations with SUD as well as depression, which is a barrier to MOUD retention. Importantly for implementation, BA also is feasible and cost-effective using lay counselor delivery. Following from this prior research, BA is an ideal EBI to evaluate for improving MOUD retention using a PRS-delivered model.

This Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT) builds upon our team's formative work, as well as our recent open label-pilot (R61AT010799) to develop and pilot the PRS-delivered BA approach. Guided by Aarons' stage model and Proctor's model of implementation, we proposed a mixed-methods, Type 1 hybrid effectiveness-implementation study to evaluate implementation and the effectiveness of the intervention on MT retention.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Valerie D Bradley, MPS
  • Phone Number: 443-405-2849
  • Email: vbradley@umd.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21223
        • Recruiting
        • University of Maryland Baltimore (UMD Drug Treatment Center)
        • Contact:
        • Sub-Investigator:
          • Melanie Bennett, PhD
        • Sub-Investigator:
          • Aaron Greenblatt, PhD
        • Sub-Investigator:
          • Annabelle M Belcher, PhD
      • College Park, Maryland, United States, 20742
        • Not yet recruiting
        • University of Maryland College Park
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Initiated methadone at the study site in the past three months (and no less than two weeks prior to study enrollment) or demonstrated challenges with methadone adherence in the past three months as indicated by one or more of the following: a) at least one missing take-home bottle at the time of bottle return; b) screened negative for methadone in routinely administered clinic urinalysis tests; c) transitioned from an extended take-home bottle schedule to daily dosing schedule; or d) at least one missed methadone dose in the past 3 months as identified through clinic records
  • Minimum of 18 years old

Exclusion Criteria:

  • Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation
  • Inability to understand the study and provide informed consent in English
  • Positive pregnancy status at enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer-Delivered Behavioral Activation ("Peer Activate")
Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention.
Behavioral: Peer-Delivered Behavioral Activation ("Peer Activate")
The PRS-delivered Peer Activate intervention will consist of approximately four weekly "core" sessions (approximately 30 minutes-1 hour) with two additional sessions to reinforce core content, and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to assist in their retention and persistence in methadone treatment and incorporating value-driven, substance-free, rewarding activities into their daily life.
No Intervention: Treatment As Usual
Participants in the TAU group will receive treatment as usual (weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MT Retention
Time Frame: Measured at final follow up (approximately six-months post-baseline assessment)
Defined dichotomously as retention (yes/no) in methadone treatment
Measured at final follow up (approximately six-months post-baseline assessment)
MT Persistence
Time Frame: Measured at final follow up (approximately six-months post-baseline)
Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)
Measured at final follow up (approximately six-months post-baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Feasibility Measured by Intervention Initiation
Time Frame: Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment)
Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention. We will also collect qualitative feedback relating to feasibility.
Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment)
Intervention Acceptability Measured by Intervention Attendance
Time Frame: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)
Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, we will measure the % of patients enrolled who attend ≥75% sessions. We will also collect qualitative feedback relating to acceptability.
Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)
Intervention Fidelity Measured by Independent Rating
Time Frame: Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and we will assess the % of intervention components delivered as intended.
Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
MT Retention
Time Frame: Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
Defined dichotomously as retention (yes/no) in methadone treatment
Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
MT Persistence
Time Frame: Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)
Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
Changes in substance use
Time Frame: Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
Assess prevalence of opioid use and other substance use (urinalysis and timeline follow back)
Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms
Time Frame: Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)
Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.
Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)
Change in depressive symptoms
Time Frame: Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.
Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
Changes in substance use
Time Frame: Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)
Assess prevalence of opioid use and other substance use (urinalysis and timeline followback)
Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, College Park

Collaborators

University of Maryland, Baltimore
Henry Ford Health System

Investigators

  • Principal Investigator: Jessica F Magidson, PhD, University of Maryland, College Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1816868

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After all primary analyses are complete, de-identified data will be made available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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