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

社区卫生工作者书面暴露疗法治疗妊娠期 PTSD 的非劣效性试验

基本信息

批准号：
10685463
负责人：
Yael I Nillni
金额：
$ 50.3万
依托单位：
BOSTON UNIVERSITY MEDICAL CAMPUS
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-17 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10685463
关键词：
Address Affect Aftercare Black race Boston Caring Characteristics Clinic Clinical Cognitive Communities Community Health Aides Data Discipline of obstetrics Discrimination Dropout Effectiveness Emotions Evidence based treatment Feasibility Studies Future Health Disparities Research Health Personnel Hospitals Impairment Improve Access Individual Infant Intervention Interview Length Low Birth Weight Infant Low income Maternal Health Maternal Mortality Measures Medical Medical center Memory Mental Depression Mental Health Minority Minority Women New England Outcome Participant Patients Perinatal Population Heterogeneity Post-Traumatic Stress Disorders Postpartum Depression Postpartum Period Pregnancy Pregnancy Outcome Pregnant Women Premature Birth Process Provider Publications Quality of Care Race Randomized Randomized, Controlled Trials Research Risk Specialist Stigmatization Stress Supportive care Surveys Symptoms System Testing Time Training Trauma United States National Institutes of Health Vision Visit Woman Writing active control addiction adverse pregnancy outcome behavioral health brief intervention care preference depressive symptoms design effectiveness evaluation effectiveness testing ethnic diversity ethnic minority ethnic minority population evidence base follow-up future implementation hospital care implementation barriers implementation trial long-term sequelae maternal morbidity member obstetric care patient engagement patient-level barriers perceived discrimination perinatal mental health perinatal period perinatal women personalized approach postpartum outcome prevent process evaluation psychiatric symptom psychological symptom psychosocial racial diversity racial minority racial minority population racism recruit safety net scale up screening service utilization social stigma system-level barriers treatment as usual treatment disparity

项目摘要

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.

项目总结/摘要患有创伤后应激障碍（PTSD）的孕妇发生不良妊娠的风险增加然而，大多数有心理健康需求的孕妇没有得到治疗，低收入和少数种族和族裔妇女在治疗利用方面的差异。围产期心理健康治疗差距主要是行为健康工作人员短缺和缺乏数据的结果在怀孕期间接受创伤后应激障碍治疗种族主义造成的心理健康污名化和医疗不信任参与护理。书面暴露疗法（WET）是一种简短的5次PTSD治疗，为了解决一线治疗的容量限制问题（例如，培训和交付的时间负担）。与一线PTSD治疗相比，WET表现出非劣效性（和更少的脱落率）。作为因此，WET的实证支持和实施优势表明，这种干预在以下方面有希望：解决在常规护理产科环境中看到的孕妇的创伤后应激障碍。非心理健康培训专家，如社区卫生工作者（CHW），提供WET可能会双重解决劳动力能力挑战和患者参与因素，如耻辱。这项研究的目的是进行一项一项随机对照试验，旨在检查WET治疗妊娠期PTSD的有效性相对于主动控制条件[即，情绪集中支持疗法（EFST）]和非劣效性， WET交付与社区卫生工作者（CHW-WET）与WET交付与心理健康临床医生。一共有240名患有PTSD的孕妇在波士顿医疗中心（BMC）接受产科护理，这是一个大型的将招募一家照顾不同种族和族裔人口的安全网医院。后基线访视时，女性将随机分配至CHW-WET（N=80）、标准WET（N=80）或EFST（N=80）。无论是WET条件的参与者将接受5个单独的会议，重点是使用写作来激活创伤记忆，处理情绪，创造意义EFST参与者将获得5名个人支持性治疗参与者将完成创伤后应激障碍和其他心理症状（例如，抑郁症）和基线时治疗参与的建议调节者，治疗后以及产后1个月、6个月和12个月。患者和提供者还将完成测量，治疗后进行访谈，以评估WET治疗的可行性、可接受性和适当性在通常的护理环境中使用。目的1是确定a）CHW-WET是否不劣于标准WET， B）CHW-WET比标准WET具有更好的保留。目标2是证明WET的有效性，在产科环境中治疗PTSD（vs. EFST）。探索性目标3将检查治疗的调节剂参与，如心理健康的耻辱，告知个性化的方法，WET治疗交付。目的 4是对WET交付方法进行过程评估。这项研究将为今后的努力提供参考，改善怀孕期间创伤后应激障碍治疗的获得和护理质量。