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

基本信息

批准号：
10434908
负责人：
Lyndsay Ammon Avalos
金额：
$ 112.04万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
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/10434908
关键词：
Address Adherence Advisory Committees Affect Anxiety Attention Black Populations Black race COVID-19 pandemic COVID-19 pandemic effects 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 Systems Hour Instruction Integrated Delivery of Health Care Intervention Latina Latina Population Mediating Mental Depression Mental Health Mental Health Services 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&apos 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

项目摘要

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) 是一种使人衰弱且代价高昂的疾病，影响超过 20% 的产后女性 COVID-19 大流行导致黑人和拉丁裔人数急剧增加。抑郁症的发病率，而美国已经在与精神卫生保健方面根深蒂固的不平等作斗争美国预防服务工作组最近建议女性： PPD 风险增加应转诊咨询以降低 PPD 风险。水平（例如缺乏时间或金钱）和系统级障碍（例如供应商短缺），现在又加上 COVID-19 大流行给接受咨询带来了挑战，尤其是黑人和拉丁裔治疗开始率已经较低的人群迫切需要证据- 为这些高风险和弱势妇女提供可获取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且由理论驱动的干预措施然而，标准 MBI 需要 8 周 30 多个小时的面对面或在线会议。对于患有高抑郁症状负担的孕妇来说，这通常过于激烈。小剂量（每天 10-20 分钟，持续 6 周）、基于移动 (mHealth) 的 MBI，适用于患有高血压的孕妇抑郁症状在减少抑郁症状方面表现出有希望的可行性和初步疗效结果抑郁症症状为全面的试验提供支持，我们将进行混合有效性- 测试 mHealth MBI 减少产后抑郁症状有效性的实施研究在黑人和拉丁裔孕妇中，产后抑郁症风险增加，并检查障碍和促进因素该研究将在 Kaiser Permanente Northern 进行。加利福尼亚州 (KPNC)，一个人口多元化、综合性的综合医疗保健服务系统 KPNC 的通用围产期抑郁症筛查计划将被用于我们将有效地识别符合条件的女性，将 600 名孕妇（300 名拉丁裔和 300 名黑人）随机分组。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为期 6 周、每天 10-20 分钟的计划我们将与 HeadspaceTM 合作，定制数字平台。实施正念计划并获取患者报告的抑郁症结果（主要）。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、此外，利用本次试验的结果，我们将确定最佳剂量和定制数字干预措施的实施评估结果将非常适用。计划纳入自定进度的移动健康正念干预措施的系统。