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STUDY PROTOCOL article
Front. Psychiatry
Sec. Digital Mental Health
Volume 16 - 2025 | doi: 10.3389/fpsyt.2025.1544753
Reducing the risk of perinatal depression using an app-based cognitive behavioral therapy program: protocol of a randomized controlled trial
Provisionally accepted
Li Tang 1
Hua Qing 2 Hong Li 2
Chunfeng Liu 3 Haijin Wang 2 Yao Sun 2 Qian Tan 2 Yanqiong Wu 2 Yang Xiao 2 Jianying Lai 2 Ling Wang 4 Li Zhong 4 Fei Huang 4
Chunrong LI 1*- 1 Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
- 2 Jintang County Maternity and Child Health Hospital, Chengdu, China
- 3 Shanghai Thoven Intelligent Technology Company Ltd., Shanghai, China
- 4 Chengdu New Genegle Biotechnology Co., Ltd., Chengdu, China
Introduction: Cognitive behavioral therapy (CBT) is recognized as one of the most effective methods for reducing the risk of perinatal depression. However, the traditional face-to-face delivery format limits its accessibility. With the advent of digital technology, app-based CBT offers new possibilities, yet its preventive role in perinatal depression remains insufficiently explored. This study aims to determine if pregnant women using an app-based CBT program report reduced depressive and anxious symptoms compared to a control group.Methods: A two-arm parallel randomized controlled trial of 290 pregnant women will be conducted at Jintang County Maternity and Child Health Hospital in Chengdu, China. Eligible participants who consent to participate will be recruited at 20-24 weeks of gestation and randomly assigned to either the intervention group, which will complete an 8-week mobile app-based CBT program (CareMom), or a control group, which will receive an attention-matched 8-week relaxation training program, also delivered via a mobile app. Randomization will be performed using a computer-generated random number sequence. Primary outcomes include changes in scores on the Edinburgh Postnatal Depression Scale, the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder 7-item from baseline to 6 weeks postpartum. Outcome analyses will be performed on both the intention-to-treat and per-protocol populations.Discussion: This trial evaluates an app-based CBT program for reducing the risk of perinatal depression. Improved maternal mental health not only benefits the mothers themselves but also may facilitate more optimal parenting behaviors, which could exert a positive influence on the cognitive, emotional, and behavioral development of the infant.
Keywords: cognitive behavioral therapy, Perinatal depression, prevention, randomized controlled trial, Digital technology
Received: 13 Dec 2024; Accepted: 24 Mar 2025.
Copyright: © 2025 Tang, Qing, Li, Liu, Wang, Sun, Tan, Wu, Xiao, Lai, Wang, Zhong, Huang and LI. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Chunrong LI, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.