Aim: The purpose of this study is to design a research protocol for the clinical testing of the "Mommy go" for pregnant women with a risk of postpartum depression.
Design: A non-blinded randomized controlled trial.
Methods: A randomized controlled study will be performed from January 2018 to the completion of the study. The intervention group will follow the "Mommy go" protocol and the control group will receive traditional support. We will use the Edinburgh Postpartum Depression Scale and the Chinese version of the Postpartum Depression Predictors Inventory-Revised to measure the risk of postpartum depression in pregnant women. The outcomes are clinical data, postpartum depressive mood, self-efficacy, and infant temperament. Outcomes will be assessed using questionnaires and through data generated by digital technologies.
Discussion: The expected outcomes are increased self-efficacy and infant temperament, reduced postpartum depressive mood, and improvements to postpartum depression. We expect the study to have a clinical impact on future online interventions for postpartum depression in China.
Impact: This study will provide an internet-based intervention for postpartum depression in China. It will be implemented in clinical practice if it can effectively improve postpartum depression.
Trial registration: Registered at the Chinese Clinical Trials.gov (ChiCTR1800018804).
目的: 本研究旨在为有产后抑郁风险的孕妇设计一项名为“Mommy go”的临床试验研究方案。 设计: 非盲态随机对照试验。 方法: 2018年1月至研究结束期间,将展开一项随机对照研究。干预组将采用“Mommy go”方案,而对照组将延续采用传统支持性方案。我们将使用爱丁堡产后抑郁量表和经修订的中国版产后抑郁预测量表来对孕妇患产后抑郁的风险进行衡量。结果包括临床资料、产后抑郁情绪、自我效能和婴儿气质。将通过问卷调查和数字技术数据来对结果进行评估。 讨论: 预期结果包括提高自我效能和婴儿气质,减少产后抑郁情绪,改善产后抑郁程度等。我们期待这一研究能对中国未来产后抑郁症的在线干预产生临床性影响。 影响: 本研究将为我国产后抑郁症的网络干预提供依据。如果本研究可帮助有效改善产后抑郁症,则将在临床上得到应用。 试验注册: 我们已经在网站Chinese Clinical Trials.gov中注册这项研究(ChiCTR1800018804)。.
Keywords: internet-based intervention; nursing; postpartum depression; pregnancy; prevention and control; research design.
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