HEAL Together: Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase

Sponsor
University of Maryland, College Park (Other)
Overall Status
Completed
CT.gov ID
NCT04248933
Collaborator
University of Maryland, Baltimore (Other), National Center for Complementary and Integrative Health (NCCIH) (NIH)
37
2
1
15.3
18.5
1.2

Study Details

Study Description

Brief Summary

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 pilot trial, the investigators will evaluate the feasibility, acceptability, and fidelity of this approach (implementation outcomes) and preliminary effectiveness on methadone treatment retention at three months.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer-Delivered Behavioral Activation (Peer Activate)
N/A

Detailed Description

Opioid use disorder (OUD) disproportionately affects low-income, racial/ethnic minorities (Stahler, 2018). MOUD is efficacious for treating OUD. However, adherence to MOUD is often low, which includes poor treatment retention, especially among low-income, racial/ethnic minority individuals (Stahler, 2018;Williams, 2017). This may be due to barriers such as stigma, challenges navigating services, housing instability, fluctuating motivation and readiness, and other structural and psychosocial factors (Timko, 2016;Carroll, 2015).

Peer recovery coaches (PRCs) may be uniquely suited to address these barriers to retention (Jack, 2017;Bassuk, 2016). PRCs are trained individuals who have a personal, lived experience with substance use. Using their lived experience, PRCs can support individuals with OUD to stay retained in care. Rapid increases in the use of PRCs nationwide demonstrates the appeal of employing PRCs as a potentially sustainable solution to support the behavioral treatment needs in OUD care. Yet, few evidence-based interventions have been evaluated for PRC delivery to promote MOUD retention.

Prior research has been inconclusive regarding psychosocial interventions to support MOUD retention (Timko, 2016;Carroll, 2017). Reinforcement-based approaches, such as contingency management, have empirical support for improving MOUD retention, but also can have low adoption in community settings due to organizational and provider barriers, including cost in medically underserved areas (Timko, 2016;Carroll, 2017;Carroll, 2015). Successful interventions need to be not only effective in improving MOUD retention, but also be feasible and sustainable to deliver for underserved populations.

Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving MOUD retention for low-income, minority individuals with OUD (Magidson, 2011). Originally developed as an efficacious treatment for depression, BA aims to increase positive reinforcement by promoting engagement in adaptive, valued behaviors (Lejuez, 2011). By targeting increases in positive reinforcement, BA has been effective in improving substance use disorder (SUD) treatment retention and preventing future relapse among low-income, minority individuals with SUD. Further, BA has improved medication adherence (i.e., for HIV) among low-income, minority populations with SUD, as well as depression, which may also be a barrier to MOUD retention. Importantly for implementation, BA has previously been implemented in low-resource settings (largely internationally) using lay health workers (e.g., peers, community health workers). However, to date, prior work has yet to evaluate a PRC-delivered BA intervention to support MOUD retention.

This study builds upon formative work to adapt and evaluate PRC-delivered BA to support MOUD retention for low-income, minority individuals initiating methadone at an outpatient, opioid treatment program in a medically underserved community in Baltimore, Maryland (Magidson, 2011;Magidson, 2018;Satinsky, 2020). The current study has three phases, the first being formative, qualitative work, to adapt the proposed treatment approach. The second phase is a pilot trial (current phase). The pilot trial is an open-label, Type 1 hybrid effectiveness-implementation trial assessing the feasibility, acceptability, and fidelity (implementation outcomes) of a PRC-delivered BA intervention for MOUD retention in methadone maintenance, and evaluating retention in the methadone program at three months (primary effectiveness outcome).

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MAT Among Low-Income, Minority Individuals With OUD - Pilot Phase
Actual Study Start Date :
Oct 9, 2020
Actual Primary Completion Date :
Oct 19, 2021
Actual Study Completion Date :
Jan 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peer-Delivered Behavioral Activation ("Peer Activate")

Participants in the Peer Activate intervention will receive a PRC-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 Peer Activate intervention will consist of weekly one-hour BA sessions led by a PRC for a period of twelve weeks. In these sessions, participants will receive individualized support in learning skills to assist in their retention and persistence in methadone treatment and will be guided through exercises aimed at incorporating substance-free, rewarding activities into their daily life. Participants will have the option to attend weekly one-hour group sessions led by a PRC to reinforce the skills learned in individual sessions.

Outcome Measures

Primary Outcome Measures

  1. MOUD Retention Rate [Measured daily from intake to post-treatment (approximately 12-weeks)]]

    The number of days (frequency) a participant visits the clinic for methadone treatment as indicated by daily clinic records.

  2. Intervention Feasibility: % of patients who agree to participate in the intervention [Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment 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.

Secondary Outcome Measures

  1. Intervention Acceptability: % of patients enrolled who attend ≥75% sessions [Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment 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.

  2. Intervention Fidelity [Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)]

    Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRC adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity, and we will assess the % of intervention components delivered as intended.

Other Outcome Measures

  1. Change in opioid use [Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)]

    Assess point prevalence of indicators of opioid use in urinalysis.

  2. Change in methadone use [Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)]

    Assess point prevalence of indicators of methadone use in urinalysis.

  3. Change in depressive symptoms [Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)]

    Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Initiated methadone at the study site or demonstrated challenges with methadone adherence in the past three months (e.g., at least one indicator of a missed methadone dose)

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland Baltimore Drug Treatment Center Baltimore Maryland United States 21223
2 University of Maryland, College Park College Park Maryland United States 20742

Sponsors and Collaborators

  • University of Maryland, College Park
  • University of Maryland, Baltimore
  • National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jessica F Magidson, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jessica Magidson, Assistant Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier:
NCT04248933
Other Study ID Numbers:
  • 1531148
  • R61AT010799
First Posted:
Jan 30, 2020
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jessica Magidson, Assistant Professor, University of Maryland, College Park
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022