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.

项目摘要/摘要 一种高效的干预措施，以防止围产期抑郁症，基于正念的认知疗法 抑郁（MBCT），存在；但是，关键的实施差距阻止了其广泛使用。虽然普遍 建议，并非所有产前护理诊所有效筛查围产期抑郁症（PD）。克服电流 必须解决美国母校发病率高和死亡率的公共卫生危机。 患病率从每年出生的380万人中的11％到20％，PD是最多的人之一 常见的生病。绝望的死亡（自杀；过量）是母亲的主要原因 死亡。尽管围产期抑郁症发生率较高，但在服务不足的情况下，精神卫生保健的可用性较低 妇女[黑人和/或土著和/或医疗补助使用者]。最近由联邦资助的物质死亡率审查 结果表明，可以预防100％的围产期抑郁症相关死亡。怀孕是最佳的 实现预防的时间：怀孕定时干预既重要（早期干预改善了预后） 和可行的（标准的产前护理包括10-12次临床访问，孕妇很有动力去进行 接受产前护理）。 Centermom，Inc。正在通过中心产品推进这些问题的解决方案： MBCT的适应旨在改善目标人群的干预措施。中心M飞行员工作 表示需要在此成功进行PD筛查和家庭练习材料的智能手机应用程序交付 努力。拟议的I阶段STTR的目的是原型智能手机应用程序，该应用可以有效地提供 有吸引力的PD筛查和中心的家庭练习材料，并测试中心产品（包括此）的中心产品 应用程序。这一询问方面的总体假设是，孕妇随机地将其随机地包含在应用程序中 中心干预措施，与往常一样（TAU）的治疗，将获得明显更好的PD筛查，将其较低 产后6周的PD率，并将对他们的天线预防性心理保健非常满意。 拟议的工作是在标准产前护理健康中实现MBCT-PD可移植性的关键步骤 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，社区合作伙伴，黑母校健康和产前护理 卫生系统将严重告知两个具体目标：特定目标1：建立一个中心M应用程序原型一致 有服务不足，怀孕的最终用户需求。我们将举办4个由5位怀孕最终用户组成的焦点小组 每个组（n = 20）专注于识别用户需求。使用此数据和初步数据，我们将完成 应用程序原型。然后，我们将与20名孕妇（n = 20）进行应用程序原型可用性测试。 特定目的2：中心M与Tau的测试有效性和有效性。我们将进行试点随机试验 有90名孕妇测试中心与Tau。我们将跟踪PD筛查和抑郁得分的速度 通过6周产后和PD护理患者满意度。研究结果将为STTR II阶段提供信息。