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: 10710407
• 负责人: Eynav Elgavish Accortt
• 金额: $ 26.27万
• 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 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10710407
• 关键词: Address; Adherence; Advocacy; Advocate; Anxiety; Anxiety Disorders; Automobile Driving; Biological; Biological Testing; 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; Licensing; Light; Los Angeles; Low Birth Weight Infant; Maternal Health; Medical; Mental Depression; Mental Health; Mental Health Services; Mental disorders; Mobile Health Application; Mood Disorders; Mothers; Multi-Institutional Clinical Trial; NF-kappa B; Outcome; Participant; Patients; Perinatal; Physicians; Physiological; Population; Positioning Attribute; Postpartum Period; Pregnancy; Pregnancy Complications; Pregnant Women; Prevalence; Primary 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; behavioral health; 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; patient navigation; perinatal mental health; perinatal outcomes; perinatal period; physical conditioning; physical symptom; premature; prenatal; prevent; prospective; provider communication; psychoeducation; psychoeducational; public health relevance; racial disparity; racism; screening; self help; skills; standard of care; stress management; stress reduction; 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.

项目总结/摘要 围产期情绪和焦虑障碍（PMAD）包括一系列的心理健康障碍，发生在 怀孕和产后一年。大约13%的女性经历PMAD。这一比率翻了一番 对于那些有不良围产期结果（APO）和黑人妇女的三倍。最近的研究表明种族主义 是造成这些健康差距的一个重要原因。文化适应，以改善与 提供者降低了少数民族患者的抑郁率，并提高了对治疗的依从性， 和联盟。歧视压力和担心经历医疗后果被认为是 增加全身炎症，这是一种已知的导致精神和身体症状的机制。炎症已经 与PMAD和APO有关，提示共同的潜在病因。我们工作中的证据 表明炎症有助于PMAD的病理生理学。拟定的初步随机对照 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，并确定我们的文化相关的移动的 健康（mHealth）干预有效改善黑人孕妇的结果， 干预组与对照组相比。文化相关模块包括建立沟通 和自我宣传技能，并提供一个支持网络。本研究的主要目的是提供 指导黑人妇女围产期的临床护理，目的是改善心理健康， 健康和身体健康结果。次要目标是检查新的炎症特征 作为干预措施的一个功能，以减少该人群中的PMAD。因为炎症可能是 诊断PMAD，确定其作用可能揭示潜在的干预目标，并提供关键的 提高妇女长期健康的知识。将在150名黑人中前瞻性评估PMAD症状 孕妇，其中一半将随机接受文化相关的移动健康干预。我们 假设干预组中的妇女PMAD和APO的发生率降低， 坚持精神健康治疗，并将报告自我宣传技能增加，沟通增加 与供应商的合作，以及减少与歧视有关的压力。他们还将提高生物风险 指标包括较低的循环C反应蛋白和差异表达的转录谱， 炎性基因，其特征是血斑中炎性转录因子的活性降低。给定 黑人母亲中PMAD和APO的高负担以及对孕产妇的众多后果 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 可能导致这些影响的机制。这项工作是跨学科的，建立在社区网络上， 倡导者实施一种新的移动健康干预措施，该措施由真实的世界经验提供信息，旨在增强 自我宣传，减轻压力，防止不良后果。