PDF(Pubmed)
Abstract：
BACKGROUND: Postpartum depression constitutes a significant public health issue, with prevalence rates ranging between 8 and 19% in high-income nations. Nevertheless, numerous barriers, including time constraints, societal stigmatization, and feelings of shame, contribute to the limited utilization of healthcare services during the postpartum period. Digital interventions offer an opportunity to enhance care for women experiencing postpartum depressive symptoms.
METHODS: We will conduct a two-arm randomized controlled trial to assess the effectiveness of a smartphone-based intervention in comparison to a treatment-as-usual control group in Germany. Our aim is to randomize 556 participants in a 1:1 ratio. Participants in the intervention group will be provided access to a preventive smartphone-based intervention called \"Smart-e-Moms,\" which incorporates therapeutic support and comprises 10 concise modules rooted in cognitive-behavioral therapy. For the intervention group, evaluations will take place at baseline (t0), prior to sessions 4 and 8 (intermediate assessments), and upon completing the intervention 6 weeks after baseline (t1). The control group\'s assessments will be at baseline (t0) and 6 weeks after baseline. Follow-up assessments are scheduled at 12 and 24 weeks from baseline to examine the short-term stability of any observed effects. We anticipate that participants in the intervention group will exhibit improvements in their postpartum depressive symptoms (as measured with the Edinburgh Postnatal Depression Scale). Additionally, we will analyze secondary outcomes, including maternal bonding, stress levels, self-efficacy, satisfaction with the intervention, and healthcare utilization.
CONCLUSIONS: If Smart-e-Moms proves to be effective, it has the potential to play a significant role in postpartum depression care within German-speaking regions. Ideally, this intervention could not only benefit maternal well-being but also improve the prospects for healthy child development.
BACKGROUND: German clinical trials registry DRKS00032324. Registered on January 26, 2024.
METHODS: We will conduct a two-arm randomized controlled trial to assess the effectiveness of a smartphone-based intervention in comparison to a treatment-as-usual control group in Germany. Our aim is to randomize 556 participants in a 1:1 ratio. Participants in the intervention group will be provided access to a preventive smartphone-based intervention called \"Smart-e-Moms,\" which incorporates therapeutic support and comprises 10 concise modules rooted in cognitive-behavioral therapy. For the intervention group, evaluations will take place at baseline (t0), prior to sessions 4 and 8 (intermediate assessments), and upon completing the intervention 6 weeks after baseline (t1). The control group\'s assessments will be at baseline (t0) and 6 weeks after baseline. Follow-up assessments are scheduled at 12 and 24 weeks from baseline to examine the short-term stability of any observed effects. We anticipate that participants in the intervention group will exhibit improvements in their postpartum depressive symptoms (as measured with the Edinburgh Postnatal Depression Scale). Additionally, we will analyze secondary outcomes, including maternal bonding, stress levels, self-efficacy, satisfaction with the intervention, and healthcare utilization.
CONCLUSIONS: If Smart-e-Moms proves to be effective, it has the potential to play a significant role in postpartum depression care within German-speaking regions. Ideally, this intervention could not only benefit maternal well-being but also improve the prospects for healthy child development.
BACKGROUND: German clinical trials registry DRKS00032324. Registered on January 26, 2024.
摘要：
背景：产后抑郁症是一个重要的公共卫生问题，高收入国家的患病率在8%到19%之间。然而，众多的障碍,包括时间限制，社会污名化，和羞耻感，有助于产后期间医疗保健服务的有限利用。数字干预为产后抑郁症状的女性提供了加强护理的机会。
方法：我们将进行一项双臂随机对照试验，以评估基于智能手机的干预措施与德国常规治疗对照组的有效性。我们的目标是以1：1的比例随机分配556名参与者。干预组的参与者将获得基于智能手机的预防性干预，称为“Smart-e-Moms，“其中包含治疗支持，包括植根于认知行为疗法的10个简明模块。对于干预组，评估将在基线(t0)进行，在会议4和8(中间评估)之前，并在基线后6周完成干预（t1）。对照组的评估将在基线(t0)和基线后6周进行。从基线开始12周和24周进行后续评估，以检查任何观察到的效果的短期稳定性。我们预计干预组的参与者将表现出产后抑郁症状的改善（根据爱丁堡产后抑郁量表进行测量）。此外,我们将分析次要结果，包括母系结合，应力水平，自我效能感,对干预的满意度，和医疗保健利用。
结论：如果智能电子妈妈被证明是有效的，它有可能在德语地区的产后抑郁症护理中发挥重要作用.理想情况下,这种干预不仅有利于孕产妇的福祉，还可以改善儿童健康发育的前景。
背景：德国临床试验注册DRKS00032324。2024年1月26日注册。
方法：我们将进行一项双臂随机对照试验，以评估基于智能手机的干预措施与德国常规治疗对照组的有效性。我们的目标是以1：1的比例随机分配556名参与者。干预组的参与者将获得基于智能手机的预防性干预，称为“Smart-e-Moms，“其中包含治疗支持，包括植根于认知行为疗法的10个简明模块。对于干预组，评估将在基线(t0)进行，在会议4和8(中间评估)之前，并在基线后6周完成干预（t1）。对照组的评估将在基线(t0)和基线后6周进行。从基线开始12周和24周进行后续评估，以检查任何观察到的效果的短期稳定性。我们预计干预组的参与者将表现出产后抑郁症状的改善（根据爱丁堡产后抑郁量表进行测量）。此外,我们将分析次要结果，包括母系结合，应力水平，自我效能感,对干预的满意度，和医疗保健利用。
结论：如果智能电子妈妈被证明是有效的，它有可能在德语地区的产后抑郁症护理中发挥重要作用.理想情况下,这种干预不仅有利于孕产妇的福祉，还可以改善儿童健康发育的前景。
背景：德国临床试验注册DRKS00032324。2024年1月26日注册。
