Development and Randomized Clinical Trial of an App-based Intervention to Reduce Postpartum Depression in High-Risk Women

基于应用程序的干预措施的开发和随机临床试验，以减少高危女性的产后抑郁症

• 批准号: 10706452
• 负责人: DEBRA L FOX
• 金额: $ 54万
• 依托单位: FOX LEARNING SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-24 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10706452
• 关键词: Affect; Child; Clinical Trials; Computers; Control Groups; Data; Development; Diagnosis; Education; Effectiveness; Electronic Health Record; Evidence based program; Family; Family Relationship; Feedback; Financial Hardship; Goals; Health Insurance; Health Personnel; High Risk Woman; Incidence; Individual; Industry; Infant Development; Intervention; Interview; Investments; Low income; Measures; Mediating; Mediator; Medicaid; Mental Depression; Mothers; Nature; Newborn Infant; Outcome; Pamphlets; Pathway interactions; Persons; Phase; Positioning Attribute; Postpartum Depression; Postpartum Period; Pregnant Women; Production; Randomized, Controlled Trials; Recommendation; Research; Risk; Schedule; Series; Testing; Third Pregnancy Trimester; Time; Training; United States Preventative Services Task Force; Woman; Women' s Group; commercialization; commercialization readiness; cost; depression prevention; design; efficacy evaluation; emotional distress; evidence base; experience; health care service utilization; implementation cost; implementation study; improved; neuropsychiatry; prevent; preventive intervention; programs; prototype; randomized trial; randomized, clinical trials; satisfaction; uptake; virtual; virtual group

Postpartum depression (PPD) affects 1 in 7 mothers in the US with double the rate among low-income women, causing emotional distress, consequences for infant development and later child adjustment, disruptions in family relationships, and significant financial burden. The ROSE Program (Reach Out, Stay Strong, Essentials for mothers of newborns) is an evidence-based preventive intervention administered as a series of 4 in-person group sessions plus one postpartum booster session. ROSE reduced cases of PPD by half in four clinical trials with low- income women. However, there are major obstacles to disseminating ROSE broadly to women at risk for PPD. If women across the nation could easily access ROSE virtually at the time and place of their choosing, the incidence of PPD could be reduced significantly. Our Phase I project developed a prototype of the first virtual ROSE session and we found 100% of 38 pregnant women at risk for PPD who trialed the session rated their experiences as highly favorable, informative, and helpful. Our current Phase II proposal goal is to finish development of a full app-based ROSE program (e-ROSE) and evaluate the app’s outcomes to lay the groundwork for commercialization and broad implementation. We know from previous trials that ROSE has better outcomes than a control consisting of an educational brochure about PPD. We now hypothesize e-ROSE and ROSE delivered as usual (ROSE) will result in better depression outcomes compared to these historical control data. We also hypothesize e-ROSE will result in a better return on investment (ROI) compared to ROSE and compared to utilization data from a second control group of women who were not offered ROSE identified through electronic health records. We will explore if depression outcomes for e-ROSE are non-inferior than for ROSE. Last, we hypothesize that perceived access and satisfaction with the intervention will serve as mediators of depression outcomes. Thus we will complete conversion of all five group sessions to an app-based platform and incorporate additional engagement and support strategies (Aim 1), test its impact on reducing PPD and improving ROI within 3 months post-delivery in a randomized trial (Aim 2), and determine if improving perceived access and satisfaction is a pathway for improving depression (Aim 3). At the end of the project, the e-ROSE product will be ready for Phase III commercialization nationwide allowing easy, low-cost distribution on a variety of platforms to the end-users as well as position us for further research via implementation studies.

在美国，七分之一的母亲患有产后抑郁症 (PPD)，这一比例是美国母亲的两倍 低收入妇女，造成情绪困扰，对婴儿发育及以后产生影响 儿童适应、家庭关系破裂以及沉重的经济负担。玫瑰 计划（伸出援手、保持坚强、新生儿母亲的必需品）是一项基于证据的计划 预防性干预以一系列 4 场面对面小组会议和 1 场会议的形式进行 产后加强课程。在四项临床试验中，ROSE 将 PPD 病例减少了一半，且低 有收入的女性。然而，向女性广泛传播 ROSE 存在重大障碍 有患产后抑郁症的风险。如果当时全国各地的女性都可以轻松地通过虚拟方式获取 ROSE， 他们选择的地点，产后抑郁症的发生率可以显着降低。我们的一期项目 开发了第一个虚拟 ROSE 会议的原型，我们发现 38 人 100% 怀孕 尝试过该课程的有患产后抑郁症风险的女性对她们的体验评价非常满意， 信息丰富且有帮助。我们当前的第二阶段提案目标是完成完整的开发 基于应用程序的 ROSE 计划 (e-ROSE) 并评估应用程序的结果以奠定基础 商业化和广泛实施。我们从之前的试验中得知，ROSE 比包含 PPD 教育手册的对照更好的结果。我们现在 假设 e-ROSE 和 ROSE 照常递送 (ROSE) 会导致更好的抑郁症 结果与这些历史控制数据进行比较。我们还假设 e-ROSE 将导致 与 ROSE 以及来自某个公司的利用率数据相比，具有更好的投资回报 (ROI) 通过电子健康识别出第二组未接受 ROSE 的女性对照组 记录。我们将探讨 e-ROSE 的抑郁症结果是否不劣于 ROSE。 最后，我们假设对干预的感知访问和满意度将作为 抑郁结果的中介因素。这样我们就完成了所有五个小组会议的转换 到基于应用程序的平台，并纳入额外的参与和支持策略（目标 1)、在交付后 3 个月内测试其对减少 PPD 和提高 ROI 的影响 随机试验（目标 2），并确定提高感知访问和满意度是否是一个 改善抑郁症的途径（目标 3）。项目结束后，e-ROSE 产品将 为全国范围内的第三阶段商业化做好准备，允许在 为最终用户提供各种平台，并让我们通过以下方式进行进一步研究： 实施研究。