A multisite randomized controlled trial of an internet-based program for preventing and reducing perinatal depressive symptoms

项目摘要/摘要 近20%的美国女性在治疗期间出现临床上明显的抑郁症状 怀孕或产后。孕妇和产后妇女将受益于便利的、 非药理学的、廉价的自我管理方法，例如通过互联网，以防止 出现症状和/或干预当前症状。目前，还没有系统的基于互联网的 美国存在旨在预防或治疗围产期抑郁症状的自我管理方法。 拟议的研究将通过评估基于互联网的自我管理计划来解决这一差距，以防止和 在一项大规模随机对照研究中，干预围产期抑郁症状--“妈妈咪呀”。 “妈妈咪呀”是一个自我指导的项目，女性将在怀孕的“可教时刻”开始， 当自我管理的内在动机很高时，将在产后六个月内完成。这个 该计划包含一种新的组件组合，旨在使女性增强自我效能感， 情绪自律和感受到的社会支持。与我们的挪威同事一起，我们最近 在1342例围产期抑郁症状患者中建立了“妈妈咪呀”治疗的可行性和有效性 挪威和我们在美国试行了一个演示版本。这项拟议的研究基于我们的发现，通过 针对不同的美国受众调整干预措施；使用国家和以中心为基础的(地方)战略 招募不同种族/族裔和社会经济地位的妇女；并通过增加少量的指导性 支持(《妈妈咪呀Plus》)。这项三臂纵向随机对照试验的总体目标是 评估这种基于互联网的自我管理方法在不同性别的妇女中的效果和机制 美国(n=1950)。登记的孕妇将被随机分配到三组中的一组：(1)妈妈 在整个怀孕期间和产后前六个月，他们参与了44个单元；(2) 《Mamma Mia Plus》，他们参与了《Mamma Mia》模块，并接受了来自 注册护士；或(3)常规产前/产后护理。第一个具体目标是按组评估效果 关于主要结果的兴趣，抑郁症状的严重程度，随着时间的推移。第二个目标是评估 团体对主观幸福感、焦虑和压力的影响。使用基于以下内容的概念框架 个人和家庭自我管理理论，第三个目标是评估可能的中介变量(自我效能， 情绪自律、感知支持)和可能的调节因素(例如，种族/民族、医疗保健类型 这种自我管理方法可能不同于挪威随机对照试验中的方法。我们寻求 利用基于互联网的技术改变预防围产期抑郁症状的临床模式 自我管理方法，允许广泛的可访问性和广泛的覆盖范围 如果证明有效，“妈妈咪呀”可能是一种低成本、可持续的、 预防和干预围产期抑郁症状的可翻译选项。

PROJECT SUMMARY/ABSTRACT Nearly 20% of women in the United States experience clinically significant depressive symptoms during pregnancy or the postpartum period. Pregnant and postpartum women would benefit from easily accessible, non-pharmacologic, and inexpensive self-management approaches, such as via the internet, to prevent development of symptoms and/or intervene with current symptoms. At present, no systematic internet-based self-management approaches designed to prevent or treat perinatal depressive symptoms exist in the U.S. Our proposed study will address this gap by evaluating an internet-based self-management program to prevent and intervene with perinatal depressive symptoms— “Mamma Mia”— in a large scale randomized controlled study. “Mamma Mia” is a self-guided program that women will begin during the “teachable moment” of pregnancy, when intrinsic motivation for self-management is high, and will complete by six months postpartum. The program contains a novel combination of components designed to enable women to enhance self-efficacy, emotional self-regulation, and perceived social support. With our Norwegian colleagues, we recently established the feasibility and efficacy of “Mamma Mia” for perinatal depressive symptoms in 1342 women in Norway and we piloted a demonstration version in the U.S. The proposed study builds upon our findings by adapting the intervention for a diverse U.S. audience; by using national and hub-based (local) strategies for recruiting women of diverse racial/ethnic and socioeconomic status; and, by adding a small amount of guided support (“Mamma Mia Plus”). The overall goal of this three-arm longitudinal randomized controlled trial is to evaluate the effects and mechanisms of this internet-based self-management approach in diverse women in the U.S. (n=1950). Enrolled pregnant women will be randomly assigned to one of three groups: (1) “Mamma Mia” in which they engage in 44 modules throughout their pregnancy and the first six months postpartum; (2) “Mamma Mia Plus” in which they engage in the “Mamma Mia” modules plus receive brief guided support from a registered nurse; or (3) usual prenatal/postpartum care. The first specific aim is to evaluate effects by group on the primary outcome of interest, depressive symptom severity, over time. The second aim is to evaluate effects by group on subjective well-being, anxiety, and stress. Using a conceptual framework based upon Individual and Family Self-Management Theory, the tertiary aim is to evaluate possible mediators (self-efficacy, emotion self-regulation, perceived support) and possible moderators (e.g., race/ethnicity, type of healthcare clinician) of this self-management approach, which may differ from those in the Norwegian RCT. We seek to shift the clinical paradigm regarding prevention of perinatal depressive symptoms by using an internet-based self-management approach that allows for wide-ranging accessibility and large reach to individuals across all geographical regions of the U.S. If proven efficacious, “Mamma Mia” may be a low-cost, sustainable, and translatable option for prevention of and intervention in perinatal depressive symptoms.