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STUDY PROTOCOL article

Front. Psychiatry
Sec. Public Mental Health
Volume 16 - 2025 | doi: 10.3389/fpsyt.2025.1491410

Evaluating the effectiveness of integrated traditional Chinese and Western treatment based on symptom grading: a study protocol for a multi-center, randomized controlled trial of patients with depressive disorder

Provisionally accepted
Jiaxi MAI Jiaxi MAI 1Tingwei Zhou Tingwei Zhou 2,3Chen WANG Chen WANG 2Junrong Ye Junrong Ye 2Jiao Chen Jiao Chen 2,3Wen Wang Wen Wang 2,3Pan Yuanxin Pan Yuanxin 2,3Yanheng WEI Yanheng WEI 2Lexin YUAN Lexin YUAN 2Hang Yang Hang Yang 2Shengwei WU Shengwei WU 2Jianxiong GUO Jianxiong GUO 2Aixiang Xiao Aixiang Xiao 2*
  • 1 Guangzhou First People's Hospital, Guangzhou, Guangdong Province, China
  • 2 Guangzhou Brain Hospital, Guangzhou Medical University, Guangzhou, China
  • 3 Guangzhou Medical University, Guangzhou, Guangdong Province, China

The final, formatted version of the article will be published soon.

    Background: Approximately one-third of depressed individuals receive treatment globally.The application rate of traditional Chinese medicine (TCM) for treating depression globally remains still relatively low. The proposed study presents a pilot trial to evaluate the effectiveness of interventions at different levels in improving depression status in community populations.Methods: A randomized controlled trial will be conducted in two communities in Guangdong, China, with a follow-up period of 12 weeks. Participants will be randomly allocated to control or intervention groups. Participants in the control group will be assigned to routine care, while participants in the intervention group will receive TCM intervention measures. The participants in the intervention group will receive integrated traditional Chinese and Western treatment according to the symptom grading of depression severity. Primary outcome measurements include the Patient Health Questionnaire (PHQ-9), the Hamilton Depression Rating Scale (HAMD-17) and the Self-Rating Depression Scale (SDS). Secondary outcome measurements include the Athens Insomnia Scale (AIS), the Epworth Sleepiness Scale (ESS), the Multiple Mental Health Literacy Scale (MMHL), the Short-Form 12 (SF-12) and the Treatment Emergent Symptom Scale (TESS). The data will be collected at baseline (T1), two weeks after intervention (T2), four weeks after intervention (T3), eight weeks after intervention (T4), and twelve weeks after intervention (T5).Discussion: This study will provide an experimental basis for the effectiveness of hierarchical integrated traditional Chinese and Western medicine (ITCWM) in improving depression of patients with different degrees of depression. At the end of the study, the results are expected that the experimental group will effectively improve the depressive symptom, improve sleep quality, and enhance mental health awareness.

    Keywords: Depression, Integrated Traditional Chinese and Western treatment, Symptom grading, randomized controlled trials, Protocols

    Received: 07 Sep 2024; Accepted: 13 Jan 2025.

    Copyright: © 2025 MAI, Zhou, WANG, Ye, Chen, Wang, Yuanxin, WEI, YUAN, Yang, WU, GUO and Xiao. 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: Aixiang Xiao, Guangzhou Brain Hospital, Guangzhou Medical University, Guangzhou, China

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