Onsite PTSD Treatment to Improve MOUD Outcomes (OPTIMO): a hybrid Type 1 effectiveness-implementation trial of harm reduction PTSD care at syringe service programs

项目摘要/摘要 我们的目标是改善阿片使用障碍(OUD)治疗的参与度和有效性 注射药物(PWID)合并创伤后应激障碍(PTSD)。阿片类药物的使用 美沙酮和丁丙诺啡等精神障碍(Mouds)非常有效，但未得到充分利用。对于PWID， 创伤后应激障碍非常常见(25%-50%)，加剧了非法阿片类药物的使用，使过量服药的可能性增加了一倍，以及 增加感染艾滋病毒/丙型肝炎病毒的风险。因为创伤后应激障碍是不良结局的一个可改变的风险因素， 降低创伤后应激障碍症状的严重程度可以改善情绪调节，并有助于保留PWID以挽救生命 穆兹。通过与纽约州的三个减少伤害组织合作，我们建议适应 认知处理疗法(CPT)，一种循证的创伤后应激障碍治疗，针对PWID的独特需求 创伤后应激障碍。使CPT适应于OUD人群和SSP交付将使我们能够接触到具有高 慢性创伤后应激障碍的发生率，不经常使用传统医疗机构，以及经历严重的与OUD相关的 伤害。现场创伤后应激障碍治疗以改善Moud预后(Optimo)将是CPT的创新模式， 因此，灵活剂量的CPT将通过远程医疗在SSP提供，SSP工作人员导航员提供 额外的面对面支持。我们的研究团队在与SSP合作方面有着良好的记录，以提供 现场低障碍模具，与患有创伤后应激障碍的PWID合作，并成功使CPT适应低 资源、高逆境、共生物质使用障碍和远程保健服务。在R61目标1中， 我们将调整CPT以适应PWID和在SSP的交付。在疾控中心系统干预框架的指导下 适应和实施研究的综合框架，我们修改后的CPT协议将是 通过：1)来自利益相关者咨询委员会的意见和2)来自潜在消费者的反馈 SSP工作人员(6个重点小组；n=4-6)。随后，在R61目标2中，我们将初步测试和提炼Optimo的 单臂开放试验(n=15)在SSP设置中的接受性和可行性 参与者、远程服务提供商和SSP导航员提供的成果和流程措施。在满足R61之后 证明了可行性和可接受性的里程碑，我们将进行混合类型1有效性- 实施试验：我们将招募252名患有OUD和PTSD的SSP参与者，并随机进行1：1 优化或等待名单对照，比较创伤后应激障碍症状、Moud滞留、阿片类药物使用、 和注射相关风险(R33目标1)。为了为未来的扩展工作提供信息，我们将系统地评估 Optimo的覆盖范围、采用、实施和预期维护及其决定因素 与参与者、供应商和SSP领导层的访谈(R33目标2)。完成这些目标将导致 更好地整合精神卫生保健和MODS，以更好地留住PWID的高危人群，因此 减少未经处理的OUD的费用。

Project Summary/Abstract Our goal is to improve opioid use disorder (OUD) treatment engagement and effectiveness for people who inject drugs (PWID) with co-occurring posttraumatic stress disorder (PTSD). Medications for opioid use disorder (MOUDs) such as methadone and buprenorphine are highly effective but underused. For PWID, PTSD is exceedingly common (25-50%), intensifies illicit opioid use, doubles overdose likelihood, and increases risk of HIV/HCV infection. Because PTSD is a modifiable risk factor for negative OUD outcomes, reducing PTSD symptom severity can improve emotional regulation, and help PWID stay retained to lifesaving MOUDs. In collaboration with three harm reduction organizations in New York State, we propose to adapt Cognitive Processing Therapy (CPT), an evidence-based PTSD treatment, for the unique needs of PWID with PTSD. Adapting CPT for the OUD population and SSP delivery will allow us to reach PWID who have high rates of chronic PTSD, infrequently use conventional healthcare settings, and experience severe OUD-related harms. Onsite PTSD Treatment to Improve MOUD Outcomes (OPTIMO) will be an innovative model of CPT, whereby flexibly dosed CPT will be delivered via telehealth at SSPs and SSP staff navigators provide additional in-person support. Our study team has a proven track record of collaborating with SSPs to provide onsite low-barrier MOUDs, working with PWID who have PTSD, and successfully adapting CPT to low resource, high adversity contexts, co-occurring substance use disorders, and telehealth delivery. In R61 Aim 1, we will adapt CPT for PWID and delivery at SSPs. Guided by CDC’s framework for systematic intervention adaptation and Consolidated Framework for Implementation Research, our modified CPT protocol will be tailored through: 1) input from a stakeholder advisory board and 2) feedback from potential consumers and SSP staff (6 focus groups; n = 4-6). Subsequently, in R61 Aim 2, we will preliminarily test and refine OPTIMO’s acceptability and feasibility in the SSP setting by conducting a one-armed open trial (n = 15) and collecting outcome and process measures from participants, teleproviders, and SSP navigators. Upon meeting R61 milestones of demonstrated feasibility and acceptability, we will conduct a hybrid Type 1 effectiveness- implementation trial: we will enroll 252 SSP participants with co-occurring OUD and PTSD and randomize 1:1 to OPTIMO or wait-list control, comparing treatment effects on PTSD symptoms, MOUD retention, opioid use, and injection-related risks (R33 Aim 1). To inform future scaling efforts, we will systematically evaluate OPTIMO’s reach, adoption, implementation, and anticipated maintenance and their determinants through interviews with participants, providers, and SSP leadership (R33 Aim 2). Completing these aims will lead to more optimal integration of mental health care and MOUDs to better retain a high-risk population of PWID, thus reducing the toll of untreated OUD.