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一种 2 型混合集群随机试验的设计、实施和初步结果,该试验将针对重症抑郁症的筛查和治疗纳入为提供阿片类激动剂疗法的专科诊所。

Design, implementation and preliminary results of a type-2 hybrid cluster-randomized trial of integrating screening and treatment for major depressive disorder into specialty clinics providing opioid agonist therapies in Ukraine.

机构信息

Section of Infectious Diseases, Yale School of Medicine, New Haven, CT, United States.

Center for Interdisciplinary Research on AIDS, Yale University, New Haven, CT, United States; Department of Social and Behavioral Sciences, Yale School of Public Health, Yale University, New Haven, CT, United States.

出版信息

Contemp Clin Trials. 2023 Aug;131:107248. doi: 10.1016/j.cct.2023.107248. Epub 2023 May 30.

Abstract

INTRODUCTION

Ukraine has a high prevalence of co-occurring disorders (COD), defined as having both substance use (SUD) and psychiatric disorders. Major depressive disorder (MDD) is the most prevalent psychiatric disorder among people with SUD. People with COD experience poor health outcomes, and international agencies propose integrated COD care. In Ukraine, treatment for SUD is delivered in specialized substance use clinics, without providing any other medical services for comorbidities, including MDD. Here we present the protocol, along the with the preliminary results of the MEDIUM project, including observations over the first 6 months.

METHODS

A cluster-randomized type-2 hybrid trial was conducted to integrate MDD treatment into specialty clinics providing opioid agonist therapies (OAT) in Ukraine. Twelve clinics in four regions underwent randomization to control (N = 1) vs experimental arms (N = 2) in each region. Clinicians at experimental sites received tele-education through modified project ECHO using a facilitated screening, evaluation, and treatment algorithm of depression, with or without financial incentives. Service-, patient- and provider-level data were collected for the analysis every 6 months for 24 months.

PRELIMINARY RESULTS

For service delivery outcomes, 4421 patients enrolled on OAT across all sites were assessed for MDD for screening (76.7%), evaluation with diagnosis (43.5%) and treatment (30.7%) for MDD; 13.8% continued treatment at least for 6 months. For patient-level outcomes, 1345 patients and 54 providers participated in serial surveys every six months.

CONCLUSION

This study will be the first to explore integrated COD care in Ukraine and generate evidence on effective service integration and delivery strategies for people with COD receiving treatment at substance use clinics with broader implications for Eastern Europe and Central Asia region.

摘要

引言

乌克兰共存障碍(COD)的患病率较高,共存障碍定义为同时存在物质使用障碍(SUD)和精神障碍。在 SUD 患者中,最常见的精神障碍是重度抑郁症(MDD)。患有 COD 的人健康状况较差,国际机构提议提供共存障碍综合护理。在乌克兰,SUD 的治疗是在专门的物质使用诊所进行的,没有为共病(包括 MDD)提供任何其他医疗服务。在这里,我们提出了该协议,并展示了 MEDIUM 项目的初步结果,包括前 6 个月的观察结果。

方法

我们进行了一项集群随机 2 型混合试验,以将 MDD 治疗纳入乌克兰提供阿片类激动剂治疗(OAT)的专科诊所。四个地区的 12 个诊所按随机分组,每个地区的对照(N=1)和实验组(N=2)。实验组的临床医生通过使用简化项目 ECHO 进行远程教育,采用抑郁症的简化筛查、评估和治疗算法,提供或不提供财务激励。在 24 个月的时间内,每 6 个月收集一次服务、患者和提供者层面的数据进行分析。

初步结果

在服务提供结果方面,所有地点的 4421 名接受 OAT 的患者接受了 MDD 的筛查(76.7%)、评估(43.5%)和治疗(30.7%);13.8%的患者至少接受了 6 个月的治疗。在患者层面的结果方面,1345 名患者和 54 名提供者每 6 个月参加一次连续调查。

结论

这项研究将是首次探索乌克兰共存障碍综合护理,并为在接受物质使用诊所治疗的共存障碍患者中进行有效的服务整合和提供策略提供证据,这对东欧和中亚地区具有更广泛的意义。

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