Efficacy of Internet-based peer education for postpartum depression: Study protocol of a Randomized Controlled Trial

Yumei Zhou^*Xiao-Wan XiongHan ZhouXiao-Ming MaBing YanJiang-Ning QiuXiao-Yi ChenLiu-Juan ZhangYan-Fang WeiXiao-Bing ZhengLin-Qing LiShao-Jun ChenYin-Li XuSi-Yi HanYu-Fen LinYu-Qin Xu^*Yan-Hua Gou^*

• Shenzhen Traditional Chinese Medicine Hospital, Shenzhen ，Guangdong, China

Introduction: Postpartum depression (PPD) is widely and profoundly affecting family and social stability. But now the consultation rate of overall PPD population is still not ideal for practical reasons. This study observes the effectiveness of Internet-based peer education, a promising treatment approach that may effectively and fairly serve the PPD group, so as to benefit more people in the future. Objectives:This study integrates internet-based peer education to serve PPD groups effectively and equitably, aiming to benefit more people. It explores IPE's efficacy vs RHE in reducing symptom severity at 6-week intervention and 16-week follow-up. Methods: This study is a randomized, parallel, and controlled trial, consist of a 6-week treatment period along with a 12-week follow-up period. 88 patients diagnosed as PPD will be recruited. They will be randomly assigned to one of two groups, internet-based peer education (IPE) group and regular health education (RHE) group, in a 1:1 ratio. Both groups will receive RHE along the 6-week treatment, while subjects in IPE group will receive 6-week online peer education additionally. The primary outcome is the response rate based on scores of 17-item Hamilton Depression Rating Scale at the week 6 and 12. The secondary outcomes include Edinburgh Postpartum Depression Scale (EPDS), World Health Organization Quality of Life Scale Brief (WHOQOL-BREF) and Self-Efficacy to Manage Chronic Disease Scale (SEMCD). All these scales will be evaluated at baseline, 1, 2, 4, 6 and 12 weeks after the initiation of intervention. Conclusion: The results of this RCT on Internet-based peer education for postpartum depression will provide an assessment of the feasibility of the protocol and data for power calculations to inform the development of a larger scale trial. Ethics and dissemination: This protocol has been ethically approved by the local medical ethical committee (No. K2023-029-01) and complies with the Declaration of Helsinki and principles of Good Clinical Practice. Informed consent is obtained before study enrolment and only coded data will be stored in a secured database. Notably, participants will not be compensated for their work, time spent, or travel expenses incurred during the study period.