INTRODUCTION Smartphone app interventions based on cognitive-behavioral therapy (CBT) are promising scalable alternatives for treating mental disorders, but the evidence of their efficacy for postpartum depression is limited. We assessed the efficacy of Motherly, a standalone CBT-based smartphone app, in reducing symptoms of postpartum depression. METHODS Women aged 18-40 with symptoms of postpartum depression were randomized either to intervention (Motherly app) or active control (COMVC app). The primary outcome was symptoms of depression measured by the Edinburgh Postnatal Depression Scale (EPDS) at post-treatment. Secondary outcomes were anxiety symptoms, parental stress, quality of sleep, behavioral activation, availability of response-contingent positive reinforcement, and clinical improvement at post-treatment and 1-month follow-up. Exploratory analyses were performed to investigate if app engagement was associated with treatment response. RESULTS From November 2021 to August 2022, 1,751 women volunteered, of which 264 were randomized, and 215 provided primary outcome data. No statistically significant differences were found between groups at post-treatment: intervention: mean (SD): 12.75 (5.52); active control: 13.28 (5.32); p = 0.604. There was a statistically significant effect of the intervention on some of the secondary outcomes. Exploratory analyses suggest a dose-response relationship between Motherly app engagement and outcomes. CONCLUSION Our standalone app intervention did not significantly reduce postnatal depression symptoms when compared to active control. Exploratory findings suggest that negative findings might be associated with insufficient app engagement. Consistent with current literature, our findings suggest that standalone app interventions for postpartum depression are not ready to be implemented in clinical practice.

中文翻译：

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独立智能手机应用程序治疗产后抑郁症的疗效：一项随机对照试验。


引言 基于认知行为疗法 （CBT） 的智能手机应用程序干预是治疗精神障碍的有前途的可扩展替代方案，但其对产后抑郁症疗效的证据有限。我们评估了基于 CBT 的独立智能手机应用程序 Motherly 在减轻产后抑郁症状方面的疗效。方法 18-40 岁有产后抑郁症状的女性被随机分配到干预组 （Motherly app） 或主动对照组 （COMVC app）。主要结局是治疗后通过爱丁堡产后抑郁量表 （EPDS） 测量的抑郁症状。次要结局是焦虑症状、父母压力、睡眠质量、行为激活、反应或有正强化的可用性以及治疗后和 1 个月随访时的临床改善。进行探索性分析以调查应用程序参与度是否与治疗反应相关。结果 从 2021 年 11 月到 2022 年 8 月，有 1,751 名女性自愿参加，其中 264 名是随机分配的，215 名提供了主要结局数据。治疗后两组间未发现统计学意义差异： 干预：平均值 （SD）：12.75 （5.52）;主动控制：13.28 （5.32）;p = 0.604。干预对一些次要结局有统计学意义的影响。探索性分析表明 Motherly 应用程序参与度与结果之间存在剂量反应关系。结论 与主动对照相比，我们的独立应用程序干预并未显著减轻产后抑郁症状。探索性结果表明，负面发现可能与应用参与度不足有关。 与目前的文献一致，我们的研究结果表明，针对产后抑郁症的独立应用程序干预尚未准备好在临床实践中实施。