A Non-Inferiority Trial Testing Delivery of Written Exposure Therapy by Community Health Workers for Treatment of PTSD During Pregnancy

项目摘要/摘要 患有创伤后应激障碍(PTSD)的孕妇不良妊娠风险增加 结果，然而，大多数有心理健康需要的孕妇没有得到治疗， 低收入、种族和少数民族妇女在治疗利用方面的差距。围产期心理 卫生治疗方面的差距首先是行为卫生人力短缺和缺乏数据的结果 关于妊娠期创伤后应激障碍的治疗。由于种族主义的进一步影响，心理健康污名和医疗不信任 全身心投入到护理中。书面暴露疗法(WEW)是一种简短的5个疗程的创伤后应激障碍治疗 以解决一线治疗的能力限制问题(例如，培训和交付的时间负担)。 与一线创伤后应激障碍治疗相比，WEW已经显示出非劣势(和较少的辍学)。AS 因此，WEW的经验支持和实施优势表明，这种干预措施有望在 解决在通常产科护理环境中看到的孕妇的创伤后应激障碍。培训非心理健康 专业人员，如社区卫生工作者(CHW)，提供湿润卫生可能会双重解决劳动力能力问题 挑战和患者参与因素，如污名。这项研究的目的是进行一项 观察湿润暴露疗法治疗妊娠期创伤后应激障碍的随机对照试验 与主动控制条件[即，情绪集中支持性治疗(EFST)]和 社区卫生工作者的湿式分娩(CHW-WEW)与心理健康临床医生的湿式分娩。一个 共有240名患有创伤后应激障碍的孕妇在波士顿医疗中心(BMC)接受产科护理，这是一家大型医院 将招募一家照顾种族和民族多样性人口的安全网医院。在此之后 在基线检查中，妇女将被随机分为CHW-WEW(N=80)、标准WEW(N=80)或EFST(N=80)。 在任何一种潮湿条件下的参与者都将收到5个单独的课程，重点是使用写作来激活 创伤记忆，处理情感，创造意义。EFST参与者将获得5名个人 支持性治疗的疗程。参与者将完成创伤后应激障碍和其他方面的既定测量 心理症状(例如，抑郁)和建议的基线治疗参与度调节因素， 治疗后，以及产后1、6和12个月。患者和提供者也将完成措施和 治疗后面谈以评估湿法分娩的可行性、可接受性和适当性 在通常的护理环境中进行治疗。目标1是确定a)CHW-湿是否不劣于标准湿 B)CHW-WEW比标准湿法具有更好的保留率。目标2是证明湿润疗法的有效性。 产科环境下创伤后应激障碍的治疗(与EFST相比)。探索性目标3将检查治疗的主持人 参与，如心理健康污名，为提供湿性治疗的个性化方法提供信息。目标 4是对湿法输送方法进行工艺评估。这项研究将为未来的努力提供参考 改善妊娠期创伤后应激障碍的治疗机会和护理质量。

Project Summary/Abstract Pregnant women with posttraumatic stress disorder (PTSD) are at increased risk for adverse pregnancy outcomes, yet the majority of pregnant women with mental health needs do not receive treatment, with disparities in treatment utilization among low-income and racial and ethnic minority women. Perinatal mental health treatment gaps are foremost a consequence of behavioral health workforce shortages and a lack of data on PTSD treatment during pregnancy. Mental health stigma and medical mistrust due to racism further impact engagement in care. Written Exposure Therapy (WET) is a brief 5-session PTSD treatment that was designed to address the capacity-limiting concerns of first-line treatments (e.g., time burden of training and delivery). WET has demonstrated non-inferiority (and fewer dropouts) when compared to first-line PTSD treatments. As such, the empirical support and implementation advantages of WET suggest the promise of this intervention in addressing PTSD among pregnant women seen in usual care obstetrics settings. Training non-mental health specialists, such as community health workers (CHWs), to deliver WET may dually address workforce capacity challenges and patient engagement factors such as stigma. The objective of this research is to conduct a randomized controlled trial to examine both the effectiveness of WET for treatment of PTSD during pregnancy against an active control condition [i.e., emotion focused supportive therapy (EFST)] and the non-inferiority of WET delivery with a community health worker (CHW-WET) vs. WET delivery with a mental health clinician. A total of 240 pregnant women with PTSD receiving obstetrical care at Boston Medical Center (BMC), a large safety net hospital that cares for a racially and ethnically diverse population, will be recruited. Following a baseline visit, women will be randomized to either CHW-WET (N=80), standard WET (N=80), or EFST (N=80). Participants in either WET condition will receive 5 individual sessions focused on the use of writing to activate the trauma memory, process emotions, and make meaning. EFST participants will receive 5 individual sessions of supportive therapy. Participants will complete well-established measures of PTSD and other psychological symptoms (e.g., depression) and proposed moderators of treatment engagement at baseline, post-treatment, and 1-, 6-, and 12-months postpartum. Patients and providers will also complete measures and interviews following treatment to assess feasibility, acceptability, and appropriateness of the WET delivery approaches in a usual care setting. Aim 1 is to determine if a) CHW-WET is non-inferior to standard WET and b) CHW-WET has better retention than standard WET. Aim 2 is to demonstrate the effectiveness of WET for treatment of PTSD (vs. EFST) in an obstetrics setting. Exploratory Aim 3 will examine moderators of treatment engagement such as mental health stigma to inform a personalized approach to WET treatment delivery. Aim 4 is to conduct a process evaluation of the WET delivery approaches. This study will inform future efforts to improve access to and quality of care for treatment of PTSD during pregnancy.