Toshishige Yuko, Chatani Natsumi, Kawasaki Shiori, Goto Shinobu, Yoshida Yuki, Takahashi Yusaku, Shimasaki Misaki, Okami Takuya, Sakaguchi Gaku, Furukawa Toshiaki A, Mizushima Hiroko, Akechi Tatsuo
Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
New Business Promotion Dept., Shionogi & Co., Ltd., 3-1-8 Doshomachi, Chuo-ku, Osaka 541-0045, Japan.
Internet Interv. 2025 Aug 5;41:100838. doi: 10.1016/j.invent.2025.100838. eCollection 2025 Sep.
Perinatal depression is a predominant and serious condition that adversely affects prenatal and postpartum women and their children. Prenatal depression is a notable predictor of postpartum depression, highlighting the need for mental health care during pregnancy. Therefore, we developed an innovative smartphone application based on interpersonal psychotherapy (IPT) to improve depressive symptoms in women in the perinatal period (i.e., from pregnancy through the first year postpartum). Here, we present a randomized controlled trial (RCT) protocol to investigate the potential of this intervention for prenatal women.
This study is an 8-week, open-label, parallel-group, stratified block RCT. In total, 350 primiparous women were randomly assigned to the intervention group-combining the smartphone application for mental health care based on IPT and care as usual-and the control group, with only care as usual. The women assigned to the intervention were encouraged to use the application for approximately 5-10 min daily. The primary outcomes included the proportion of participants with moderate-to-high satisfaction (scoring ≥17 on the 8-item Client Satisfaction Questionnaire) and changes in depressive symptoms measured by the Patient Health Questionnaire-9 from baseline to the end of the 8-week intervention.
To our knowledge, this RCT is the first to investigate the acceptability and efficacy of an IPT-based smartphone application for reducing depressive symptoms in prenatal women. If successful, the findings will contribute to the growing evidence supporting digital mental health interventions during pregnancy, offering a scalable and accessible solution for prenatal mental health care.
围产期抑郁症是一种主要且严重的病症，会对产前和产后女性及其子女产生不利影响。产前抑郁症是产后抑郁症的一个显著预测指标，这凸显了孕期心理健康护理的必要性。因此，我们开发了一款基于人际心理治疗（IPT）的创新型智能手机应用程序，以改善围产期女性（即从怀孕到产后第一年）的抑郁症状。在此，我们展示一项随机对照试验（RCT）方案，以研究这种干预措施对产前女性的潜在效果。
本研究是一项为期8周的开放标签、平行组、分层区组随机对照试验。总共350名初产妇被随机分配到干预组（结合基于人际心理治疗的智能手机心理健康护理应用程序和常规护理）和对照组（仅接受常规护理）。被分配到干预组的女性被鼓励每天使用该应用程序约5 - 10分钟。主要结局包括中度至高度满意的参与者比例（在8项客户满意度问卷上得分≥17）以及通过患者健康问卷-9从基线到8周干预结束时测量的抑郁症状变化。
据我们所知，这项随机对照试验是首次研究基于人际心理治疗的智能手机应用程序在减轻产前女性抑郁症状方面的可接受性和疗效。如果成功，研究结果将为支持孕期数字心理健康干预的越来越多的证据做出贡献，为产前心理健康护理提供一种可扩展且可及的解决方案。
