mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression

针对有产后抑郁症风险的黑人和拉丁裔孕妇的移动健康正念干预

• 批准号: 10244836
• 负责人: Lyndsay Ammon Avalos
• 金额: $ 120.31万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10244836
• 关键词: Address; Adherence; Advisory Committees; Affect; Anxiety; Attention; COVID-19 pandemic; California; Cause of Death; Child; Clinic; Control Groups; Counseling; Data; Devices; Diagnosis; Discipline of obstetrics; Economic Burden; Effectiveness; Effectiveness of Interventions; Electronic Health Record; Enrollment; Ethnic Origin; Evidence based intervention; Gold; Health; Healthcare; Healthcare Systems; Hour; Instruction; Integrated Delivery of Health Care; Intervention; Latina; Mediating; Mental Depression; Mental Health; Monitor; Mothers; Outcome; Patient Outcomes Assessments; Patients; Personal Satisfaction; Persons; Pilot Projects; Population; Population Heterogeneity; Postpartum Depression; Postpartum Period; Postpartum Women; Pregnant Women; Prevention; Preventive service; Provider; Questionnaires; Race; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Relapse; Resources; Risk; Role; Services; Sleep; Sleep disturbances; Stress; Suicide; System; Time; Vulnerable Populations; Woman; Women' s Health; active control; anxiety symptoms; arm; base; black women; care delivery; coronavirus disease; cost; depressive symptoms; digital; digital intervention; dosage; effective intervention; effective therapy; effectiveness evaluation; effectiveness implementation study; effectiveness testing; evidence base; experience; high risk; implementation evaluation; implementation facilitators; implementation intervention; improved; mHealth; mindfulness; mindfulness intervention; pandemic disease; peripartum depression; post intervention; pregnant; pressure; prevent; primary outcome; programs; public health relevance; racial and ethnic disparities; reduce symptoms; response; routine care; screening program; secondary outcome; skills; stress symptom; system-level barriers; theories; treatment arm

ABSTRACT Postpartum depression (PPD) is a debilitating and costly condition affecting over 20% of postpartum women and disproportionately impacts Blacks and Latinas. The COVID-19 pandemic is leading to a severe increase in the rate of depression while the US is already struggling with deep-seated inequities in mental health care for Black and Latina populations. The US Preventive Services Task Force recently recommended that women at increased risk of PPD should be referred for counseling to reduce the risk of PPD. However, numerous patient- level (e.g. lack of time or money) and system-level barriers (e.g. shortage of providers), now compounded with the COVID-19 pandemic, pose challenges to the receipt of counseling, particularly among Black and Latina populations that already experienced a lower rate of treatment initiation. There is an urgent need for evidence- based accessible and scalable mental health care options for these high-risk and vulnerable women. Mindfulness-Based Interventions (MBIs) are effective and theory-driven interventions for reducing depression symptoms. However, standard MBIs require 30+ hours of in-person or online sessions for 8 weeks and are often too intense for pregnant women with high depression symptom burden. Our pilot study of a self-paced, small dosage (10-20 minutes/day for 6 weeks), mobile-based (mHealth) MBI for pregnant women with high depression symptoms demonstrated promising feasibility and preliminary efficacy results in reducing depression symptoms providing support for a fully-powered trial. We will conduct a hybrid effectiveness- implementation study to test the effectiveness of the mHealth MBI to reduce postpartum depression symptoms in Black and Latina pregnant women at increased risk of PPD, and examine barriers and facilitators of implementation within a large healthcare system. The study will take place at Kaiser Permanente Northern California (KPNC), an integrated health care delivery system with a diverse population and comprehensive electronic health records. KPNC’s universal perinatal depression screening program will be leveraged to efficiently identify eligible women. We will randomize 600 pregnant (300 Latina and 300 Black) women into the intervention arm or time- and attention-matched control arm and ask them to practice mindfulness or another program for 6 weeks, 10-20 minutes a day. We will partner with HeadspaceTM and tailor the digital platform to deliver the mindfulness program and obtain adherence data. Patient-reported outcomes of depression (primary outcome), anxiety, stress and sleep (secondary outcomes), and attention monitoring and acceptance (target engagements) will be collected 3 times during the study (baseline, post intervention, and 4 weeks postpartum). Implementation of the intervention will be evaluated using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation and Maintenance). Further, using the results of this trial, we will determine optimal dosage and tailor the digital intervention. Findings from the implementation evaluation will be highly applicable to systems that are planning to incorporate self-paced mHealth mindfulness interventions.

摘要 产后抑郁症(PPD)是一种使人虚弱且代价高昂的疾病，影响着超过20%的产后妇女 对黑人和拉丁裔的影响也不成比例。新冠肺炎大流行导致儿童死亡率严重增加 在美国已经在与心理健康保健方面根深蒂固的不平等作斗争的同时，抑郁症的比率 黑人和拉丁裔人口。美国预防服务工作组最近建议， 应参考产后抑郁风险增加的咨询，以降低产后抑郁的风险。然而，无数的病人- 水平(例如，缺乏时间或金钱)和系统一级的障碍(例如，提供者短缺)，现在再加上 新冠肺炎大流行对接受咨询提出了挑战，特别是在黑人和拉丁裔中 已经经历了较低的治疗启动率的人群。迫切需要证据-- 为这些高危和脆弱的妇女提供基于可获得和可扩展的精神卫生保健选择。 基于正念的干预(Mbi)是有效的、理论驱动的减少抑郁的干预措施。 症状。然而，标准的mbi需要8周30多个小时的面对面或在线课程，并且是 对于有高抑郁症状负担的孕妇来说，往往太强烈了。我们的初步研究是一种自定进度的， 小剂量(每天10-20分钟，连续6周)，基于移动(MHealth)的MBI，适用于患有高血糖的孕妇 抑郁症状在减少抑郁方面显示出良好的可行性和初步疗效 抑郁症状为一项全面试验提供了支持。我们将实施一种混合效力- 测试mHealth MBI减轻产后抑郁症状有效性的实施研究 在患PPD风险增加的黑人和拉丁裔孕妇中，检查障碍和促进者 在大型医疗保健系统中实施。研究将在Kaiser Permanente Northern进行 加州(KPNC)，一个人口多样化和全面的综合医疗保健提供系统 电子健康记录。KPNC的普遍围产期抑郁症筛查计划将被用来 有效识别符合条件的女性。我们将随机将600名怀孕妇女(300名拉丁裔和300名黑人)分成 干预臂或时间和注意力匹配的控制臂，并要求他们练习正念或其他 计划6周，每天10-20分钟。我们将与HeadspaceTM合作，并定制数字平台以 提供正念计划，并获得坚持数据。患者报告的抑郁症结果(主要 焦虑、压力和睡眠(次要结果)，以及注意力监测和接受(目标 将在研究期间收集3次(基线、干预后和产后4周)。 将使用RE-AIM框架(REACH、有效性、 采用、实施和维护)。此外，利用这次试验的结果，我们将确定最佳方案 剂量和量身定做的数字干预。执行情况评估的结果将非常适用 到计划纳入自定进度的mHealth正念干预的系统。