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

为服务不足的孕妇提供基于正念的认知疗法：开发 Center M 进行商业化

• 批准号: 10759776
• 负责人: Ellen Lane Tilden
• 金额: $ 41.63万
• 依托单位: CENTER MOM, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10759776
• 关键词: Address; Advisory Committees; Affect; Birth; Black race; Caring; Cellular Phone; Cessation of life; Charge; Child; Child Health; Child Support; Client satisfaction; Clinic; Clinical; Colorado; Computers; Current Procedural Terminology Codes; Data; Depression screen; Early Intervention; Educational Curriculum; Effectiveness; Family; Fees; Focus Groups; Funding; Group Therapy; Health; Healthcare Systems; Home; Hospitals; Indigenous; Infant; Insurance; Intervention; Knowledge; Licensing; Marketing; Maternal Health; Maternal Mortality; Medicaid; Mental Depression; Mental Health; Mental Health Services; Mission; Modeling; Morbidity - disease rate; Neonatal; Oregon; Outcome; Overdose; Patient Care; Personal Satisfaction; Persons; Phase; Pilot Projects; Postpartum Period; Pregnancy; Pregnant Women; Prenatal care; Prevalence; Prevention; Prevention strategy; Preventive; Primary Prevention; Psychiatry; Psychology; Public Health; Questionnaires; Randomized; Recommendation; Reporting; Research; Risk Reduction; Science; Signal Transduction; Site; Small Business Technology Transfer Research; Social Workers; Suicide; System; Tablets; Target Populations; Testing; Time; Training; Underserved Population; United States National Institutes of Health; Universities; Visit; Woman; Work; antenatal; care providers; child bearing; commercial application; commercialization; community partnership; cost; depression prevention; design; digital; digital delivery; digital health; effective intervention; efficacy testing; empowerment; evidence base; experience; flexibility; health equity; high risk; implementation barriers; implementation science; improved; improved outcome; innovation; intervention delivery; maternal morbidity; mindfulness; mindfulness based cognitive therapy; mobile application; mortality; patient engagement; peripartum depression; portability; preference; pregnant; prenatal; prevent; prevention service; programs; prototype; randomized trial; satisfaction; smartphone application; sustainability framework; telehealth; tool; treatment as usual; usability

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.

项目概要/摘要 预防围产期抑郁症的高效干预措施——基于正念的围产期认知疗法 抑郁症（MBCT）是存在的；然而，关键的实施差距阻碍了它的广泛使用。 建议，并非所有产前保健诊所都能有效筛查围产期抑郁症 (PD)。 执行差距对于解决美国孕产妇高发病率和死亡率的公共卫生危机至关重要。 每年 380 万人出生，PD 的患病率为 11% – 20%，是最常见的疾病之一。 常见的生育疾病和绝望死亡（自杀；服药过量）是孕产妇的主要原因。 尽管围产期抑郁症的发病率较高，但服务不足的人群获得的心理保健服务却较少。 妇女[黑人和/或土著和/或医疗补助使用者]。最近联邦资助的孕产妇死亡率审查。 结果表明，与围产期抑郁症相关的死亡 100% 是可以预防的。 实现预防的时间：妊娠定时干预至关重要（早期干预可改善结果） 可行（产前检查标准包括10-12次临床检查，孕妇的积极性很高） CenterMom, Inc. 正在通过 Center M 产品推进这些问题的解决方案： MBCT 的改编旨在改善我们中心 M 试点工作的干预实施。 表明需要通过智能手机应用程序提供 PD 筛查和家庭实践材料才能成功实现这一目标 拟议第一阶段 STTR 的目的是开发一款能够有效交付的智能手机应用程序原型。 有吸引力的 PD 筛查和 Center M 家庭练习材料，并测试包含此内容的 Center M 产品 这一调查的总体假设是孕妇随机使用该应用程序。 与常规治疗 (TAU) 相比，中心 M 干预将获得明显更好的 PD 筛查，并且具有较低的 产后 6 周的 PD 发生率，并对他们的产前预防性心理保健非常满意。 拟议的工作是在标准产前保健健康范围内实现 MBCT-PD 可移植性的关键一步 我们的团队（包括生物医学专家）的系统和可接受性。 商业化、心理学、正念、社区伙伴关系、黑人孕产妇健康和产前护理 卫生系统将严格告知两个具体目标： 具体目标 1：构建一致的 Center M 应用程序原型 针对未得到充分服务的怀孕最终用户的需求，我们将开展 4 个由 5 名怀孕最终用户组成的焦点小组。 每组（N=20）专注于确定用户需求，我们将使用这些数据和初步数据来完成。 然后我们将对另外 20 名孕妇 (n = 20) 进行应用程序原型可用性测试。 具体目标 2：测试 Center M 与 TAU 的功效和有效性 我们将进行一项试点随机试验。 对 90 名孕妇进行 M 中心与 TAU 测试 我们将跟踪 PD 筛查率和抑郁评分。 产后 6 周和腹膜透析护理患者的满意度研究结果将为 STTR 第二阶段提供信息。