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.

项目摘要/摘要 我们的目标是改善阿片类药物使用障碍（OUD）的治疗参与和有效性 注射药物（PWID）具有创伤后应激障碍（PTSD）。阿片类药物使用的药物 疾病（MOUDS），例如Metagadone和丁丙诺啡是非常有效但没有使用的。对于pwid， PTSD极为普遍（25-50％），加强非法阿片类药物使用，双倍的药物可能性和 增加HIV/HCV感染的风险。由于PTSD是负结果的可修改风险因素，因此 减轻PTSD症状严重程度可以改善情绪调节，并帮助PWID保持保留至救生 mouds。与纽约州的三个减少危害组织合作，我们建议适应 认知加工疗法（CPT）是一种基于证据的PTSD治疗，可满足PWID的独特需求 PTSD。为OUD人口和SSP交付调整CPT将使我们能够达到较高的PWID 慢性PTSD的比率很少使用常规的医疗机构，并且经历了严重的OUD相关 危害。现场PTSD处理以改善MOUD结果（Optimo）将是CPT的创新模型， 因此，将通过SSP和SSP员工Navigators通过远程医疗来灵活服用CPT 额外的面对面支持。我们的学习团队有与SSP合作的可靠记录以提供 与拥有PTSD的PWID合作，并成功调整了CPT， 资源，高广告环境，同时出现的物质使用障碍以及远程医疗服务。在R61 AIM 1中， 我们将在SSP上调整CPT的PWID和交付。在CDC的系统干预框架的指导下 适应和合并的实施研究框架，我们的修改CPT协议将是 量身定制：1）来自利益相关者顾问委员会的输入以及2）潜在消费者和 SSP员工（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 通过进行单臂开放试验（n = 15）并收集SSP设置的可接受性和可行性 参与者，远程旋转器和SSP导航员的结果和过程措施。见R61 具有可行性和可接受性的里程碑，我们将进行1型混合型有效性 - 实施试验：我们将招募252名SSP参与者，并具有同时发生的OUD和PTSD，并随机分组1：1 为了进行优化或等待列表的控制，比较对PTSD症状的治疗效果，MOUD保留，阿片类药物的使用， 和注射相关的风险（R33 AIM 1）。为了告知未来的扩展工作，我们将系统地评估 Optimo通过 与参与者，提供者和SSP领导的访谈（R33 AIM 2）。完成这些目标将导致 精神卫生保健和穆德的最佳整合以更好地保留高风险的PWID，因此 减少未经处理的Oud的损失。