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: 10480615
• 负责人: DEBRA L FOX
• 金额: $ 87.02万
• 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/10480615
• 关键词: Advisory Committees; Affect; Child; Clinical Trials; Computers; Control Groups; Data; Development; Diagnosis; 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; Investments; Low income; Measures; Mediating; Mediator of activation protein; Medicaid; Mental Depression; Mothers; Nature; Newborn Infant; Outcome; Pamphlets; Pathway interactions; Persons; Phase; Positioning Attribute; Postpartum Depression; Postpartum Period; Pregnant Women; Preventive service; Production; Randomized Clinical Trials; Randomized Controlled Trials; Research; Risk; Schedule; Series; Testing; Third Pregnancy Trimester; Time; Training; Woman; Women' s Group; base; commercialization; 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; satisfaction; uptake; virtual

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.

产后抑郁症(PPD)在美国每7个母亲中就有1个受到影响，其患病率是 低收入妇女，造成情绪困扰，对婴儿发育和以后的影响 儿童适应、家庭关系破裂和沉重的经济负担。玫瑰花 计划(伸出援手，保持坚强，新生儿母亲必备)是一项以证据为基础的计划 预防性干预作为一系列4次面对面小组会议加1次进行 产后助推会。在四项临床试验中，ROSE将产后抑郁的病例减少了一半 有收入的女性。然而，向妇女广泛传播玫瑰存在主要障碍。 有患产后抑郁症的风险。如果全国各地的妇女都能很容易地接触到，那么在当时， 选择地点，可显著降低产后抑郁的发生率。我们的第一阶段项目 开发了第一次虚拟玫瑰会话的原型，我们发现38名孕妇100% 有产后抑郁症风险的女性在试验中对自己的经历给予了高度评价， 信息量大，而且很有帮助。我们目前的第二阶段提案目标是完成一个完整的 基于应用程序的ROSE计划(e-ROSE)并评估应用程序的结果，为奠定基础 为了商业化和广泛的实施。我们从之前的试验中得知，罗丝 比由一本关于产后抑郁的教育手册组成的对照结果更好。我们现在 假设E-ROSE和ROSE照常交付(ROSE)将导致更好的抑郁 结果与这些历史对照数据进行比较。我们还假设e-Rose将导致 投资回报率(ROI)高于ROSE，也高于 没有提供玫瑰的第二组女性通过电子健康识别 唱片。我们将探索e-ROSE的抑郁结果是否不逊于ROSE。 最后，我们假设，对干预的感知访问和满意度将作为 抑郁结局的中介者。因此，我们将完成所有五个小组会议的转换 到基于应用程序的平台，并纳入其他接洽和支持战略(AIM 1)，测试其在交付后3个月内降低PPD和提高ROI的效果 随机试验(目标2)，并确定提高感知的可获得性和满意度是否 改善抑郁的途径(目标3)。在项目结束时，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 向最终用户提供各种平台，并通过以下方式为我们的进一步研究定位 实施研究。