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

产后抑郁症（PPD）影响美国七分之一的母亲， 低收入妇女，造成情绪困扰，对婴儿发育和以后的后果 孩子的适应，家庭关系的中断，以及巨大的经济负担。玫瑰 计划（伸出援手，保持坚强，新生儿母亲的必需品）是一个以证据为基础的 预防性干预作为一系列4个面对面的小组会议加上一个 产后强化疗程ROSE在四项临床试验中将PPD病例减少了一半， 收入女性。然而，在向妇女广泛传播ROSE方面存在重大障碍， 有患产后抑郁症的风险如果全国各地的妇女可以很容易地访问玫瑰几乎在当时， 他们选择的地点，PPD的发生率可以显着降低。我们的第一阶段项目 我开发了第一个虚拟ROSE会话的原型，我们发现38个怀孕的人中有100% 有患产后抑郁症风险的女性在试用期将自己的经历评为非常有利， 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 商业化和广泛实施。我们从以前的试验中得知，玫瑰 比对照组（包括PPD教育手册）更好的结果。我们现在 假设e-ROSE和ROSE照常给药（ROSE）将导致更好抑郁 与这些历史对照数据进行比较。我们还假设e-ROSE将导致 与ROSE相比，以及与来自 第二个对照组的妇女谁没有提供玫瑰通过电子健康确定 记录我们将探讨e-ROSE的抑郁结局是否不劣于ROSE。 最后，我们假设，感知的访问和满意度的干预将作为 抑郁症的结果。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，并纳入额外的参与和支持战略（Aim 1），在交付后3个月内测试其对降低PPD和提高ROI的影响， 随机试验（目标2），并确定是否改善感知访问和满意度是一个 改善抑郁症的途径（目标3）。在项目结束时，e-ROSE产品将 准备在全国范围内进行第三阶段商业化，从而可以在一个 为终端用户提供各种平台，并使我们能够通过 执行研究。

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.