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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

基本信息

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
项目类别：
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

项目摘要

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.

项目总结/摘要预防围产期抑郁症的一种高效干预措施，以正念为基础的围产期认知疗法抑郁症（MBCT）存在;然而，严重的实施差距阻碍了其广泛使用。尽管普遍来说虽然产前检查是一项值得推荐的检查，但并非所有的产前检查诊所都能有效地筛查围产期抑郁症（PD）。克服当前执行差距是解决美国孕产妇高发病率和死亡率的公共卫生危机的当务之急。在每年出生的380万人中，PD的患病率为11 - 20%，是最常见的疾病之一。常见的生育疾病绝望死亡（自杀;吸毒过量）是孕产妇死亡的主要原因死亡虽然围产期抑郁症的发病率较高，但在服务不足的人群中，女性[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，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：怀孕时间干预至关重要（早期干预可改善结果）和可行的（产前护理标准包括10-12次临床访问，孕妇有很高的积极性，接受产前护理）。CenterMom公司正在通过Center M产品推进这些问题的解决方案： MBCT的适应性设计，以改善我们的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交付PD筛查和家庭实践材料，以成功地在这方面努力拟议的第一阶段STTR的目的是建立一个智能手机应用程序的原型，吸引人的PD筛查和Center M家庭实践材料，并测试Center M产品，附录对这一调查路线的总体假设是，怀孕的人被随机分配到应用程序中，中心M干预与常规治疗（TAU）相比，将接受显著更好的PD筛查，产后6周PD发生率高，对产前预防性心理保健满意度高。拟议的工作是一个关键的一步，以实现MBCT-PD的便携性标准产前保健健康系统和可接受性在服务不足的孕妇。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，黑人孕产妇健康和产前护理卫生系统将为两个具体目标提供重要信息：具体目标1：建立一个符合服务不足，怀孕的最终用户的需求。我们将进行4个焦点小组，由5名怀孕的最终用户组成每组（N=20），重点是确定用户需求。利用这些数据和初步数据，我们将完成 app prototype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M中心与TAU中心的疗效和有效性。我们将进行一项初步随机试验 90名孕妇来测试M中心和TAU中心我们将跟踪PD筛查率和抑郁评分通过产后6周及PD护理患者满意度。研究结果将告知STTR II期。