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

促进经历亲密伴侣暴力的女性保留阿片类药物治疗：一种针对 PTSD 的新型阶梯式护理模式

• 批准号: 10812139
• 负责人: E. Jennifer Edelman
• 金额: $ 127.15万
• 依托单位: YALE UNIVERSITY
• 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/10812139
• 关键词: Address; Affect; Behavior Therapy; Caring; Client; Clinic; Clinical Trials; Cognitive Therapy; Communities; Country; Data; Diagnosis; Domestic Violence; Dose; Effectiveness; Effectiveness of Interventions; Eligibility Determination; Ethnic Population; Evidence based intervention; Evidence based treatment; Exploration, Preparation, Implementation, and Sustainment; Future; Health; Hybrids; Impairment; Individual; Interdisciplinary Study; Intervention; Knowledge; Manuals; Medicine; Mental Depression; Mental Health; Modeling; National Institute of Drug Abuse; Nature; Opioid; Outcome; Personal Satisfaction; Phase; Post-Traumatic Stress Disorders; Process; Protocols documentation; Provider; Randomized, Controlled Trials; Recovery; Reproducibility; Research; Resources; Role; Service delivery model; Services; Structure; Symptoms; Training; Trauma; United States; Woman; Work; addiction; clinically significant; community involvement; compare effectiveness; coping; design; effective intervention; empowerment; evidence base; experience; health disparity; health related quality of life; implementation science; implementation/effectiveness; improved; improved outcome; individualized medicine; innovation; intimate partner violence; medication for opioid use disorder; member; novel; opioid overdose; opioid use disorder; post-traumatic stress; primary outcome; process evaluation; psychologic; racial minority population; racial population; reduced substance use; response; satisfaction; secondary outcome; service providers; social health determinants; stressor; substance use; therapy design; treatment as usual; treatment program; violence exposure

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.

抽象的 患有阿片类药物使用障碍 (OUD) 的女性尤其容易受到亲密伴侣暴力 (IPV) 和 创伤后应激障碍 (PTSD)，高达 78% 接受阿片类药物使用障碍 (MOUD) 药物治疗的女性正在接受治疗 在过去 6 个月的 PTSD 诊断中，72%-78% 的 W-IPV 经历有临床意义。 创伤后应激障碍（PTSD）相关的功能障碍可有效降低治疗的保留率。 PTSD 可以减少物质，但许多人不建议进行 IPV，因为它们是基于暴露的疗法 过去发生的创伤 – 不适用于正在进行的创伤，如针对其他疾病的综合干预措施。 健康状况可改善 MOUD 治疗的结果，但尚无基于证据的治疗方法可以证明 将急需的 IPV 和 PTSD 关注纳入 MOUD 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操作 专为经历 IPV 的女性 (W-IPV) 设计的行为干预措施，以减少 PTSD 症状和其他症状 PCT+ 专注于帮助 W-IPV 应对当前由其产生的压力源。 创伤经历；可以由非临床专业人员（可能更多）分 8 次进行讲授 在 MOUD 治疗环境中可用且负担得起，一些女性可能无法单独对 PCT+ 做出反应，并且需要。 HOPE 是一种针对 IPV 的认知行为疗法，由 16 次疗程提供。 硕士水平的治疗师并结合了我们的创新治疗模式。 方法将这两种干预措施整合到阶梯式护理模型中，以创建 PCT+2HOPE。 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、 然后实施随机对照试验来评估 PCT+2HOPE 与常规治疗的比较 收集与指导未来维持相关的数据。我们将征求 W-IPV 的意见以及直接意见。 服务和监督人员告知： 在 OUD 治疗环境中系统识别 IPV 的协议， 转介至家庭暴力服务提供者的流程以及 PCT+ 和 HOPE 的调整 然后，我们将评估 PCT+2HOPE 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）。 探讨干预措施的有效性在种族和族裔群体之间以及内部是否存在差异，以及 以 SDOH 为基础，我们的跨学科研究团队包括社区- 总部位于 OUD 和家庭暴力服务提供商，以及在 IPV、PTSD 和 OUD 相关护理；具有适应性设计的临床试验； 我们的研究通过生成数据具有巨大影响力。 一种可重复且可扩展的方法，可以改变 OUD 的 W-IPV 独特需求的治疗方法。