Promoting Retention in Opioid Treatment among Women Experiencing Intimate Partner Violence: A Novel Stepped Care Model Targeting PTSD

摘要 患有阿片类药物使用障碍（OUD）的妇女受到亲密伴侣暴力（IPV）的影响不成比例， PTSD，高达78%的接受阿片类药物使用障碍（MOUD）治疗的女性经历 IPV在过去的6个月里无论PTSD诊断如何，72%-78%的W-IPV经历了临床意义 PTSD相关的功能障碍。PTSD减少治疗保留。干预措施有效地针对 PTSD，以减少物质，但许多人不建议IPV，因为他们是基于自我保护的治疗， 过去发生的创伤-而不是持续的创伤，如IPV。其他综合干预措施 健康状况改善了MOUD治疗的结果，但没有基于证据的治疗方法， 将急需的IPV和PTSD重点纳入MOUD治疗。当前中心治疗+（PCT+） 和通过赋权帮助克服创伤后应激障碍（HOPE）是两个基于证据的，手动化的 为经历IPV（W-IPV）的女性设计的行为干预措施，以减少PTSD症状和其他 创伤相关的结果。PCT+专注于帮助W-IPV科普当前的压力源， 创伤经历;它可以由非临床的专业人员在8个疗程中提供，这些人员可能更多 在MOUD治疗环境中可用且负担得起。一些女性可能对PCT+没有反应，需要 额外的治疗。HOPE是一种IPV特定的认知行为疗法，由 硕士水平的治疗师，并纳入赋权和稳定治疗模式。我们的创新 这种方法将这两种干预措施打包在阶梯式护理模式中，以创建PCT+2 HOPE。这一分阶段 在美国东北部的三个MOUD治疗环境中进行的研究将由 探索、准备、实施和维持（EPIS）框架。我们将探索，准备， 然后实施一项随机对照试验，以评价PCT+2 HOPE与常规治疗， 收集相关数据，为今后的维持提供信息。我们将征求W-IPV的意见， 服务和监督人员告知：在OUD治疗环境中系统识别IPV的协议， 向家庭暴力服务提供者转诊的程序，以及PCT+和HOPE的调整 第三阶段（R33）。然后，我们将评估PCT+2 HOPE对促进MOUD保留的影响 治疗，同时改善次要结局（例如，PTSD，IPV，客户定义的恢复）（R61阶段）。我们将 探讨干预措施的有效性在种族和族裔群体之间和内部是否存在差异， 基于SDOH。在建立伙伴关系的基础上，我们的跨学科研究团队包括社区- 基于OUD和家庭暴力服务提供商，以及在IPV，PTSD和 OUD相关护理;成瘾医学;适应性设计的临床试验;社区合作研究; 健康差距;以及实施科学。我们的研究有可能产生很大的影响， 这是一种可重复和可扩展的方法，可以改变治疗方法，以满足具有OUD的W-IPV的独特需求。

Abstract Women with opioid use disorder (OUD) are disproportionately impacted by intimate partner violence (IPV) and PTSD, with up to 78% of women receiving medication for opioid use disorder (MOUD) treatment experiencing IPV in the past 6 months. Regardless of PTSD diagnosis, 72%-78% of W-IPV experience clinically significant PTSD-related impairment in functioning. PTSD reduces treatment retention. Interventions effectively target PTSD to reduce substance, but many are not advised for IPV because they are exposure-based therapies for trauma that occurred in the past – not for trauma that is ongoing, as with IPV. Integrated interventions for other health conditions improve outcomes for MOUD treatment, yet no evidence-based treatments exist that integrate a much-needed focus on IPV and PTSD into MOUD treatment. Present-Centered Therapy+ (PCT+) and Helping to Overcome PTSD through Empowerment (HOPE) are two evidence-based, manualized behavioral interventions designed for women experiencing IPV (W-IPV) to reduce PTSD symptoms and other trauma-related outcomes. PCT+ focuses on helping W-IPV cope with current stressors that arise from their traumatic experiences; it can be delivered in 8 sessions by nonclinical, professional staff who may be more available and affordable in MOUD treatment settings. Some women may not respond to PCT+ alone and need additional treatment. HOPE is an IPV-specific cognitive behavioral therapy delivered in 16 sessions by Master’s level therapists and incorporates empowerment and stabilization treatment models. Our innovative approach packages these two interventions in a stepped care model to create PCT+2HOPE. This phased study conducted in three MOUD treatment settings in the United States northeast will be guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework. We will explore, prepare for, and then implement a randomized controlled trial to evaluate PCT+2HOPE versus treatment as usual while collecting data relevant for informing future sustainment. We will elicit input from W-IPV as well as direct service and supervisory staff to inform: protocols for systematically identifying IPV in OUD treatment settings, processes for referral to domestic violence service providers, and adaptation of the PCT+ and HOPE interventions (R33 phase). Then, we will evaluate the impact of PCT+2HOPE on promoting retention in MOUD treatment while improving secondary outcomes (e.g, PTSD, IPV, client-defined recovery) (R61 phase). We will explore whether the effectiveness of the interventions differ across and within racial and ethnic groups and based on SDOH. Building on established partnerships, our interdisciplinary study team includes community- based OUD and domestic violence service providers, and academic partners with expertise in IPV, PTSD and OUD-related care; addiction medicine; clinical trials with adaptive designs; community-partnered research; health disparities; and implementation science. Our study has potential for high impact by generating data on a reproducible and scalable approach that may transform treatment for the unique needs of W-IPV with OUD.