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

基于互联网的预防和减少围产期抑郁症状项目的多中心随机对照试验

• 批准号: 10376811
• 负责人: Patricia Anne Kinser
• 金额: $ 45.97万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-06 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10376811
• 关键词: Address; Adherence; Anxiety; Arizona; Behavior; Belief; Birth; Breast Feeding; Child; Child Development; Clinical; Clinical Research; Depression and Suicide; Development; Economic Burden; Education; Effectiveness; Emotional; Emotions; Enrollment; Ethnic Origin; Family; Geographic Locations; Goals; Health Personnel; Health Promotion; Healthcare; Human; Impairment; Individual; Infant; Informal Social Control; Internet; Intervention; Low Birth Weight Infant; Maternal and Child Health; Measures; Mediating; Mediator of activation protein; Medical Care Costs; Mental Health; Monitor; National Institute of Child Health and Human Development; Norway; Nursing Research; Outcome; Parents; Personal Satisfaction; Postpartum Depression; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Premature Birth; Prevention; Prevention strategy; Public Health; Race; Randomized; Randomized Controlled Trials; Registered nurse; Research Priority; Resources; Self Efficacy; Self Management; Self-Examination; Severities; Site; Social Perception; Social support; Societies; Socioeconomic Status; Stress; Symptoms; Testing; Time; United States; Universities; Virginia; Woman; Work; adherence rate; arm; barrier to care; base; biobehavior; clinically significant; comorbidity; cost; depressive symptoms; design; disorder prevention; evidence base; experience; health management; improved; interest; intrinsic motivation; neonatal outcome; novel; parity; perinatal depressive symptom; perinatal intervention; perinatal women; postpartum care; postpartum outcome; prenatal; prevent; primary outcome; programs; racial and ethnic; racial diversity; randomized controlled study; recruit; retention rate; secondary outcome; self-management program; skills; social stigma; societal costs; socioeconomics; study population; symptom self management; theories; treatment as usual

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.

项目总结/摘要 在美国，近20%的女性在怀孕期间经历了临床上显著的抑郁症状。 怀孕或产后期间。孕妇和产后妇女将受益于容易获得， 非药物和廉价的自我管理方法，如通过互联网，以防止 症状的发展和/或干预目前的症状。目前，没有系统的基于互联网的 自我管理的方法，旨在预防或治疗围产期抑郁症状存在于美国。 拟议的研究将通过评估一个基于互联网的自我管理计划来解决这一差距， 干预围产期抑郁症状-“妈妈咪呀”-在一个大规模的随机对照研究。 “妈妈咪呀”是一个自我指导的节目，妇女将开始在“受教的时刻”怀孕， 当自我管理的内在动机很高时，将在产后六个月完成。的 该方案包含一个新的组合，旨在使妇女能够提高自我效能， 情绪自我调节和感知的社会支持。最近，我们与挪威同事一起， 在1342名妇女中建立了“妈妈咪呀”治疗围产期抑郁症状的可行性和有效性， 挪威，我们在美国进行了示范试验。拟议的研究以我们的发现为基础， 调整干预措施，以适应不同的美国观众;通过使用国家和基于中心的（地方）战略， 招募不同种族/民族和社会经济地位的妇女;并通过增加少量的指导 支持（“妈妈咪呀Plus”）。这项三组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妇女中的效果和机制， 美国（n=1950）。入选的孕妇将被随机分配到三组之一：（1）“妈妈”组 Mia”，她们在整个怀孕期间和产后前六个月参与44个模块;（2） “妈妈咪呀+”，他们参与“妈妈咪呀”模块，并获得简短的指导支持， 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 关注的主要结果，抑郁症状严重程度，随着时间的推移。第二个目标是评估 组对主观幸福感、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，第三个目的是评估可能的中介（自我效能， 情绪自我调节，感知支持）和可能的调节器（例如，种族/民族，医疗保健类型 临床医生）的这种自我管理的方法，这可能不同于挪威RCT。我们寻求 通过使用基于互联网的方法改变有关预防围产期抑郁症状的临床范式 自我管理的方法，允许广泛的可访问性和大范围的个人在所有 如果证明有效，“妈妈咪呀”可能是一个低成本，可持续， 预防和干预围产期抑郁症状的可翻译选择。