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

改善 MOUD 结果的现场 PTSD 治疗 (OPTIMO)：注射器服务项目中减少伤害 PTSD 护理的 1 型混合有效性实施试验

• 批准号: 10812813
• 负责人: Aaron D Fox
• 金额: $ 91.58万
• 依托单位: CITY COLLEGE OF NEW YORK
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10812813
• 关键词: Abstinence; Adopted; Adoption; Affective; Belief; Buprenorphine; Caring; Chronic; Chronic Post Traumatic Stress Disorder; Client; Cognition; Cognitive; Collaborations; Consolidated Framework for Implementation Research; Data; Diagnosis; Dose; Drug usage; Effectiveness; Emotions; Enrollment; Expectancy; Feedback; Focus Groups; Future; Goals; HIV; HIV/HCV; Harm Reduction; Health Personnel; Hepatitis C; Hybrids; Individual; Injecting drug user; Injections; Intervention; Interview; Leadership; Length; Life; Maintenance; Mediator; Mental Health; Mental Health Services; Methadone; Methods; Modeling; Modification; Needle-Exchange Programs; New York; Opioid; Outcome; Outcome Measure; Overdose; Overdose reduction; Pain; Participant; Persons; Phase; Population; Post-Traumatic Stress Disorders; Procedures; Process Measure; Protocols documentation; Provider; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Resources; Risk; Risk Factors; Risk Reduction; Rural; Self Efficacy; Series; Services; Severities; Site; Substance Use Disorder; Symptoms; Testing; Training; Trauma; Waiting Lists; acceptability and feasibility; addiction; comorbidity; coping; effectiveness outcome; effectiveness-implementation RCT; effectiveness/implementation hybrid; effectiveness/implementation trial; emotion dysregulation; emotion regulation; evidence base; experience; flexibility; health care settings; high risk population; illicit opioid; implementation outcomes; improved; individual patient; injection drug use; innovation; intervention refinement; marginalization; medical specialties; medication for opioid use disorder; meetings; modifiable risk; mortality; opioid therapy; opioid use; opioid use disorder; overdose risk; participant interview; recruit; reduce symptoms; retention rate; skills; symptomatic improvement; telehealth; traditional care; treatment comparison; treatment effect

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.

项目概要/摘要 我们的目标是提高阿片类药物使用障碍 (OUD) 治疗的参与度和有效性 注射毒品 (PWID) 并同时发生创伤后应激障碍 (PTSD)。 美沙酮和丁丙诺啡等精神障碍（MOUD）对于注射吸毒者非常有效，但未得到充分利用。 创伤后应激障碍（PTSD）极为常见（25-50%），加剧了阿片类药物的非法使用，使过量用药的可能性加倍，并且 因为 PTSD 是 OUD 负面结果的一个可改变的危险因素， 减轻 PTSD 症状的严重程度可以改善情绪调节，并帮助吸毒者继续挽救生命 我们与纽约州的三个减少危害组织合作，建议进行调整。 认知处理疗法 (CPT) 是一种基于证据的 PTSD 治疗方法，可满足吸毒者的独特需求 适应 OUD 人群的 CPT 和 SSP 交付将使我们能够接触到患有高精神障碍的注射吸毒者。 慢性 PTSD 的发生率、不经常使用传统医疗机构以及经历严重的 OUD 相关症状 改善 MOUD 结果的现场 PTSD 治疗 (OPTIMO) 将是 CPT 的创新模式， 因此，灵活剂量的 CPT 将通过 SSP 的远程医疗提供，并且 SSP 工作人员导航员提供 我们的研究团队在与 SSP 合作提供额外的面对面支持方面有着良好的记录。 现场低门槛 MOUD，与患有 PTSD 的吸毒者合作，并成功使 CPT 适应低门槛 在 R61 目标 1 中，资源、高逆境、同时发生的物质使用障碍和远程医疗服务。 我们将在 CDC 系统干预框架的指导下，针对注射吸毒者和 SSP 实施 CPT。 适应和实施研究综合框架，我们修改后的 CPT 协议将是 通过以下方式量身定制：1) 利益相关者咨询委员会的意见和 2) 潜在消费者的反馈和 SSP 工作人员（6 个焦点小组；n = 4-6） 随后，在 R61 目标 2 中，我们将初步测试和完善 OPTIMO。 通过进行单臂开放试验（n = 15）并收集数据，确定 SSP 设置中的可接受性和可行性 参加者、电信提供商和 SSP 导航员的结果和过程测量。 证明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 名同时患有 OUD 和 PTSD 的 SSP 参与者，并按 1:1 随机分配 与 OPTIMO 或等候名单对照相比，比较对 PTSD 症状、MOUD 保留、阿片类药物使用的治疗效果， 以及与注入相关的风险（R33 目标 1），为了为未来的建模工作提供信息，我们将系统地进行评估。 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、提供者和 SSP 领导层的访谈（R33 目标 2）将导致： 更优化地整合精神卫生保健和 MOUD，以更好地留住注射吸毒者的高危人群，从而 减少未经处理的 OUD 造成的损失。