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

摘要 产后抑郁症（PPD）是一种使人衰弱和昂贵的条件影响超过20%的产后妇女 对黑人和拉丁裔的影响也不成比例2019冠状病毒病大流行导致 抑郁症的发病率，而美国已经在精神卫生保健方面与根深蒂固的不平等作斗争， 黑人和拉丁裔。美国预防服务工作组最近建议， PPD的风险增加应咨询，以减少PPD的风险。然而，许多患者- 在这方面，存在着两个层面的障碍（例如，缺乏时间或资金）和系统层面的障碍（例如，缺乏提供者）， COVID-19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开始率的人群。迫切需要证据- 为这些高风险和弱势女性提供基于可访问且可扩展的心理健康护理选择。 基于正念的干预（MBIs）是有效的和理论驱动的干预措施，以减少抑郁症 症状然而，标准的MBIs需要30多个小时的面对面或在线课程，为期8周， 对于抑郁症状负担高的孕妇来说往往过于强烈。我们的试点研究， 小剂量（10-20分钟/天，持续6周），基于移动（mHealth）的MBI，适用于孕妇， 抑郁症状表现出有希望的可行性和初步的疗效结果，减少 抑郁症状为全面试验提供支持。我们将进行混合式有效性- 实施研究，以测试mHealth MBI减少产后抑郁症状的有效性 在黑人和拉丁裔孕妇的PPD风险增加，并检查的障碍和促进因素， 在大型医疗保健系统中实施。该研究将在Kaiser Permanente北方进行 加州（KPNC），一个综合性的医疗保健提供系统，人口多样化， 电子健康记录。KPNC的普遍围产期抑郁症筛查计划将被利用， 有效识别合格女性。我们将600名孕妇（300名拉丁裔和300名黑人）随机分配至 干预臂或时间和注意力匹配控制臂，并要求他们练习正念或其他 6周，每天10-20分钟。我们将与HeadspaceTM合作，定制数字平台， 提供正念课程并获得依从性数据。患者报告的抑郁症结局（原发性 结果），焦虑，压力和睡眠（次要结果），以及注意力监测和接受（目标 在研究期间（基线、干预后和产后4周）将收集3次。 将使用RE-AIM框架（覆盖范围、有效性、 采用、实施和维护）。此外，使用本试验的结果，我们将确定最佳的 剂量和量身定制数字干预。执行情况评价的结果将具有高度适用性 到计划纳入自定进度的mHealth正念干预的系统。

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.