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.

项目摘要/摘要创伤后应激障碍（PTSD）的孕妇患妊娠的风险增加结果，但是大多数有心理健康需求的孕妇没有接受治疗，低收入，种族和少数民族妇女的治疗利用差异。围产期精神健康治疗差距是行为健康劳动力短缺和缺乏数据的最重要的结果怀孕期间的PTSD治疗。由于种族主义而导致的心理健康污名和医疗不信任参与护理。书面曝光疗法（湿）是设计的短暂5条PTSD治疗解决一线治疗（例如培训和分娩的时间负担）的限制能力问题。与一线PTSD治疗相比，WET表现出非效率（和更少的辍学）。作为这样，湿的经验支持和实施优势表明了这种干预的承诺在通常的护理妇产景中看到的孕妇中的PTSD。培训非精神健康提供湿的专家，例如社区卫生工作者（CHW）挑战和患者参与因素，例如污名。这项研究的目的是进行随机对照试验既检查怀孕期间湿PTSD治疗的有效性针对主动控制条件[即情绪支持疗法（EFST）] 与社区卫生工作者（CHW-WET）与精神卫生临床医生的湿务交付。一个在波士顿医疗中心（BMC），总共有240名PTSD孕妇接受产科护理将招募照顾种族和种族多样化的安全网医院。遵循基线访问，女性将被随机分为CHW-WET（n = 80），标准湿（n = 80）或EFST（n = 80）。处于任一湿条件的参与者将接受5个单独的会议，重点是使用写作激活创伤记忆，处理情绪并产生意义。 EFST参与者将获得5个人支持治疗的会议。参与者将完成公认的PTSD和其他措施心理症状（例如抑郁症）和基线治疗参与的拟议主持人，治疗后，产后1-，6和12个月。患者和提供者还将完成措施，治疗后的访谈以评估湿交付的可行性，可接受性和适当性在通常的护理环境中接近。目的1是确定a）chw-wet是否不属于标准湿及 b）CHW-WET比标准湿的保留率更好。目标2是证明湿的有效性在产科环境中对PTSD（与EFST）的处理。探索目标3将检查治疗的主持人参与度，例如心理健康污名，以告知个性化的湿治疗方法。目的 4是对湿输送方法进行过程评估。这项研究将为未来的努力提供信息在怀孕期间，改善获得PTSD治疗的护理质量。