跳至主要内容
临床试验/NCT04248933
NCT04248933已完成不适用

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

University of Maryland, College Park4 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
4
主要终点
MOUD Retention Rate: % of Patients Retained at 3 Months

研究概览

简要总结

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, minoritized 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.

详细描述

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

This study builds upon formative work to adapt and evaluate PRS-delivered BA to support MOUD retention for low-income, minoritized 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 PRS-delivered BA intervention for MOUD retention in methadone treatment, and evaluating retention in the methadone program at three months (primary effectiveness outcome).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

MOUD Retention Rate: % of Patients Retained at 3 Months

时间窗: Measured daily from intake to post-treatment (approximately 12-weeks)

Percent of patients retained in MOUD treatment at three months (i.e. still engaged in care) after intervention enrollment.

Intervention Feasibility: % of Patients Who Agree to Participate in the Intervention

时间窗: 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, was measured quantitatively as the % of patients who agreed to participate in the intervention.

次要结局

  • Intervention Fidelity: Percentage of Intervention Components Delivered by Peer as Intended(Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment))
  • Intervention Acceptability: % of Patients Who Attend ≥75% Sessions(Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Magidson

Associate Professor

University of Maryland, College Park

研究点 (4)

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