Making Mindfulness-Based Cognitive Therapy accessible for underserved pregnant people: Developing Center M for commercialization

项目摘要/摘要 一种预防围产期抑郁的高效干预--围产期正念认知疗法 抑郁(MBCT)是存在的；然而，关键的实施差距阻碍了其广泛使用。尽管普遍存在 建议，并不是所有的产前保健诊所都有效地筛查围产期抑郁症(PD)。克服当前 要解决美国产妇发病率和死亡率高的公共卫生危机，实施差距势在必行。 在每年出生的380万人中，帕金森病的患病率从11%到20%不等，是最常见的 常见的生育疾病。绝望死亡(自杀；服药过量)是产妇死亡的主要原因 死亡。尽管围产期抑郁症的发生率较高，但在服务不足的人群中，精神卫生保健的可获得性较低 妇女[黑人和/或土著和/或医疗补助用户]。最近由联邦政府资助的孕产妇死亡率审查 结果表明，100%的围产期抑郁症相关死亡是可以预防的。怀孕是最好的 实现预防的时间：孕期干预至关重要(早期干预可以改善结果) 可行(产前保健标准包括10-12次临床就诊，孕妇有很高的积极性 接受产前护理)。CenterMa，Inc.正在通过Center M产品推进这些问题的解决方案： 改编MBCT，旨在改善我们目标人群的干预交付。M中心试点工作 表明需要智能手机应用程序提供PD筛查和家庭实践材料才能成功 努力。拟议的第一阶段STTR的目的是制作一款智能手机应用程序的原型，以便有效地提供 呼吁PD筛查和Center M家庭实践材料并测试Center M产品，包括 应用程序。这一系列调查的首要假设是，孕妇随机使用这款APP 中心M干预，与常规治疗(TAU)相比，将接受显著更好的PD筛查，将有更低的 产后6周帕金森病患病率高，对产前预防性心理卫生保健工作满意度高。 拟议的工作是在标准产前保健范围内实现MBCT-PD可移植性的关键一步 系统和服务不足的孕妇的可接受性。我们的团队，包括生物医学专家 商业化、心理学、正念、社区伙伴关系、黑人产妇健康和产前护理 卫生系统将关键地告知两个具体目标：具体目标1：建立一致的Center M应用程序原型 服务不足、怀孕的最终用户需求。我们将进行由5名怀孕终端用户组成的4个焦点小组 每组(N=20)，专注于识别用户需求。利用这些数据和初步数据，我们将完成 应用程序原型。然后我们将与另外20名孕妇(n=20)进行APP原型可用性测试。 具体目标2：测试中心M与TAU的疗效和有效性。我们将进行一项试点随机试验 与90名孕妇一起去M中心与TAU进行测试。我们将跟踪PD筛查率和抑郁评分 通过6周的产后和PD护理使患者满意。研究结果将为沙田第二阶段提供资料。

PROJECT SUMMARY/ABSTRACT A highly effective intervention to prevent perinatal depression, mindfulness-based cognitive therapy for perinatal depression (MBCT), exists; however, critical implementation gaps prevent its wide use. And though universally recommended, not all prenatal care clinics effectively screen for perinatal depression (PD). Overcoming current implementation gaps is imperative to address the public health crisis of high US maternal morbidity and mortality. With prevalence ranges from 11 – 20% of the 3.8 million people who birth every year, PD is one of the most common childbearing morbidities. And deaths of despair (suicide; overdose) is the leading cause of maternal death. Though rates of perinatal depression are higher, mental health care is less available among underserved women [Black and/or Indigenous and/or Medicaid users]. Recent federally funded maternal mortality review results indicate that 100% of perinatal depression related deaths were preventable. Pregnancy is the optimal time to realize prevention: pregnancy timed intervention is both critical (early intervention improves outcomes) and feasible (prenatal care standardly includes 10-12 clinical visits, and pregnant people are highly motivated to receive prenatal care). CenterMom, Inc. is advancing solutions to these problems via the Center M product: an adaptation of MBCT designed to improve intervention delivery in our target population. Center M pilot work indicates the need for smartphone app delivery of PD screening and home practice materials to succeed in this effort. The purpose of the proposed Phase I STTR is to prototype a smartphone app that can effectively deliver appealing PD screening and Center M home practice materials and test the Center M product inclusive of this app. The overarching hypothesis to this line of inquiry is that pregnant people randomized to the app inclusive Center M intervention, vs. treatment as usual (TAU), will receive significantly better PD screening, will have lower rates of PD at 6 weeks postpartum, and will be highly satisfied with their antenatal preventive mental health care. The proposed work is a critical step to achieving MBCT-PD portability within standard prenatal care health systems and acceptability among underserved pregnant people. Our team, including experts in biomedical commercialization, psychology, mindfulness, community-partnerships, Black maternal health, and prenatal care health systems will critically inform two specific aims: Specific Aim 1: Build a Center M app prototype consistent with underserved, pregnant end user needs. We will conduct 4 focus groups consisting of 5 pregnant end users per group (N=20) focusing on identifying user needs. Using this data and preliminary data, we will complete the app prototype. Then we will conduct app prototype usability testing with 20 additional pregnant people (n = 20). Specific Aim 2: Test efficacy and effectiveness of Center M vs. TAU. We will conduct a pilot randomized trial with 90 pregnant people to test Center M vs. TAU. We will track rates of PD screening and depression scores through 6-weeks postpartum and PD care patient satisfaction. Study findings will inform STTR Phase II.