A Randomized Control Trial of a Culturally Relevant Maternal Wellness App to Improve Black Maternal Mental Health Outcomes

一项与文化相关的孕产妇健康应用程序的随机对照试验，以改善黑人孕产妇心理健康结果

• 批准号: 10593841
• 负责人: Eynav Elgavish Accortt
• 金额: $ 20.88万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-27 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10593841
• 关键词: Address; Adherence; Advocacy; Advocate; Anxiety; Anxiety Disorders; Automobile Driving; Behavioral; Biological; Biological Testing; Birth; Black race; Blood; C-reactive protein; COVID-19; CREB1 gene; Caring; Child; Childbirth; Clinical; Clinical effectiveness; Communication; Communication Barriers; Communities; Community Networks; Complication; Control Groups; Coupled; Data; Diagnosis; Diagnostic; Discrimination; Education; Etiology; Functional disorder; Gene Expression Profile; Genes; Gestational Diabetes; Goals; Health; Healthcare; Healthy People 2020; Inflammation; Inflammatory; Intervention; Knowledge; Laws; Light; Los Angeles; Low Birth Weight Infant; Maternal Health; Medical; Mental Depression; Mental Health; Mental Health Services; Mental disorders; Minority; Mobile Health Application; Mood Disorders; Mothers; Multi-Institutional Clinical Trial; Outcome; Participant; Patients; Perinatal; Physicians; Physiological; Population; Positioning Attribute; Postpartum Period; Pregnancy; Pregnancy Complications; Pregnant Women; Prevalence; Primary Health Care; Provider; Psyche structure; Public Health; Randomized; Randomized Controlled Trials; Recommendation; Reporting; Research; Research Proposals; Risk; Risk Factors; Role; Small for Gestational Age Infant; Source; Spottings; Stress; Structure; Symptoms; Techniques; Telemedicine; Testing; Visit; Well in self; Woman; Work; adverse outcome; base; black patient; black women; clinical care; comparison intervention; cultural competence; design; differential expression; effective intervention; experience; follow-up; group intervention; health disparity; health equity; improved; improved outcome; insight; jun Oncogene; mHealth; minority patient; novel; online care; perinatal mental health; perinatal outcomes; perinatal period; physical conditioning; physical symptom; premature; prenatal; prevent; prospective; psychoeducation; public health relevance; racial disparity; racism; screening; self help; skills; standard of care; stress management; support network; systemic inflammatory response; transcription factor; virtual; women of color

Project Summary/Abstract Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow us to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women’s long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. We hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. They will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that we develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes.

项目概要/摘要 围产期情绪和焦虑障碍 (PMAD) 涵盖围产期发生的一系列精神健康障碍 怀孕期间和产后一年内。大约 13% 的女性患有 PMAD。这个比率翻倍 对于那些有不良围产期结局（APO）和三倍体的黑人女性。最近的研究指出种族主义 是这些健康差异的重要根源之一。文化适应以改善沟通 提供者降低少数族裔患者的抑郁症发病率，并提高治疗依从性和洞察力 和联盟。人们认为，歧视压力和对遭受医疗后果的担忧 增加全身炎症，这是一种已知会导致精神和身体症状的机制。炎症有 与 PMAD 和 APO 都有关联，表明有共同的潜在病因。我们工作的证据 表明炎症有助于 PMAD 的病理生理学。拟议的试点随机控制 试验将使我们能够在有希望的初步结果的基础上再接再厉，并确定我们的移动设备是否与文化相关 健康（移动健康）干预可有效改善随机分组的黑人孕妇的结局 干预组与对照组进行比较。文化相关模块包括建立沟通 和自我宣传技能并提供支持网络。这项研究的主要目的是提供 黑人妇女围产期临床护理指南，旨在改善心理 健康和身体健康结果。第二个目标是检查新的炎症特征 这种变化随着减少该人群 PMAD 的干预措施而变化。由于炎症可能是 PMAD 的诊断、其作用的识别可能会揭示潜在的干预目标并提供关键的 改善妇女长期健康的知识。将前瞻性评估 150 名黑人的 PMAD 症状 孕妇，其中一半将被随机接受文化相关的移动医疗干预。我们 假设干预组中的女性 PMAD 和 APO 发生率会降低， 坚持心理健康治疗，并会报告自我倡导技能的提高，沟通的加强 与提供者合作，并减少与歧视相关的压力水平。他们的生物风险也将得到改善 指标包括较低的循环 C 反应蛋白和差异表达的转录谱 炎症基因，其特征是血斑中炎症转录因子的活性降低。给定 黑人母亲中 PMAD 和 APO 的沉重负担以及对母亲造成的众多后果 和儿童的结果，我们必须制定和实施有效的干预措施，并测试生物学 可能驱动这些效应的机制。这项工作是跨学科的，建立在社区网络的基础上 提倡实施一种新颖的移动医疗干预措施，该干预措施以现实世界的经验为基础，旨在增强 自我宣传、减轻压力并防止不良后果。