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.

项目总结/摘要 我们的目标是改善阿片类药物使用障碍（OUD）治疗的参与和有效性， 注射毒品（PWID）与并发创伤后应激障碍（PTSD）。使用阿片类药物的药物 美沙酮和丁丙诺啡等抗精神病药物（MOUD）非常有效，但未得到充分利用。对于PWID， PTSD非常常见（25-50%），加剧了非法阿片类药物的使用，使过量服用的可能性增加一倍， 增加HIV/HCV感染的风险。因为创伤后应激障碍是负面OUD结果的一个可改变的风险因素， 降低PTSD症状的严重程度可以改善情绪调节，并帮助PWID保持救生状态 MOUD。我们与纽约州的三个减少危害组织合作， 认知加工疗法（CPT），一种基于证据的PTSD治疗，用于PWID的独特需求， 创伤后应激障碍针对OUD人群和SSP交付调整CPT将使我们能够接触到具有高风险的PWID。 慢性创伤后应激障碍的发生率，不经常使用传统的医疗机构，并经历严重的OUD相关 伤害现场PTSD治疗改善MOUD结局（OPTIMO）将是CPT的创新模式， 灵活剂量的CPT将通过SSP的远程医疗提供，SSP工作人员导航员提供 额外的个人支持。我们的研究团队拥有与SSP合作的良好记录， 现场低障碍MOUD，与患有PTSD的PWID合作，并成功地将CPT适应于低障碍 资源，高逆境的情况下，共同发生的物质使用障碍，和远程保健提供。在R61目标1中， 我们将调整CPT以适应PWID和SSP的交付。以疾病预防控制中心的系统干预框架为指导 适应和实施研究的综合框架，我们修改后的CPT协议将 通过以下方式定制：1）利益攸关方咨询委员会的投入; 2）潜在消费者的反馈， SSP工作人员（6个焦点小组; n = 4-6）。随后，在R61 Aim 2中，我们将初步测试和完善OPTIMO的 通过进行单臂开放试验（n = 15）和收集 参与者、远程提供者和SSP导航员的结果和过程测量。在满足R61后 证明可行性和可接受性的里程碑，我们将进行混合1型有效性- 实施试验：我们将招募252名同时患有OUD和PTSD SSP参与者，并按1：1随机分配 OPTIMO或等待列表控制，比较治疗对PTSD症状，MOUD保留，阿片类药物使用， 和注射相关风险（R33目标1）。为了告知未来的扩展工作，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、提供者和SSP领导层的访谈（R33 Aim 2）。完成这些目标将导致 更优化地整合精神卫生保健和MOUD，以更好地保留PWID的高风险人群， 减少未经治疗的OUD的死亡率。