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.

抽象的 产后抑郁症（PPD）是一种令人衰弱且昂贵的状况，影响了20％以上的产后妇女 不成比例地影响黑人和拉丁裔。 COVID-19大流行导致严重增加 美国的抑郁症发生率，而美国已经在精神卫生保健中的深处不平等中挣扎 黑人和拉丁裔人口。美国预防服务工作队最近建议 应提及PPD的风险增加，以减少PPD的风险。但是，许多患者 - 级别（例如缺乏时间或金钱）和系统级别的障碍（例如提供者的短缺），现在与 19009年的大流行，对接受咨询构成挑战，尤其是在黑人和拉丁裔中 已经经历了治疗率较低的人群。迫切需要证据 - 这些高风险和脆弱女性的基于可访问且可扩展的心理保健选择。 基于正念的干预措施（MBI）是减少抑郁症的有效和理论驱动的干预措施 症状。但是，标准MBI需要30多个小时以上的面对面或在线会议8周，并且 对于患有高抑郁症​​状的孕妇伯恩（Burnen）通常太激烈了。我们对自节奏的试点研究， 小剂量（每天10-20分钟，持续6周），基于移动的MHealth MBI，适用于高的孕妇 抑郁症状表现出有希望的可行性和初步有效性导致降低 抑郁症状为全功率试验提供了支持。我们将进行混合有效性 - 实施研究以测试MHealth MBI减轻产后抑郁症状的有效性 在黑人和拉丁裔孕妇中，PPD风险增加，并检查 在大型医疗保健系统中实施。该研究将在北北部北部进行 加利福尼亚州（KPNC），一种综合的医疗保健提供系统，有潜水员的人口和全面 电子健康记录。 KPNC的普遍围产期抑郁筛查计划将被利用 有效地识别合格的妇女。我们将将600个怀孕（300名拉丁裔和300名黑人女性）随机纳入 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 每天进行6周，10-20分钟。我们将与头上合作，并为数字平台量身定制 提供正念计划并获得依从性数据。患者报告的抑郁症结果（主要 结局），焦虑，压力和睡眠（次要结果）以及注意力监测和接受（目标 在研究期间将收集3次（基线，干预后和产后4周）。 将使用RE-AIM框架（覆盖范围，有效性， 采用，实施和维护）。此外，使用该试验的结果，我们将确定最佳 剂量并定制数字干预。实施评估的发现将非常适用 对于计划纳入自定进度的MHealth正念干预措施的系统。