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
BackgroundApproximately one-third of depressed individuals receive treatment globally. The application rate of traditional Chinese medicine (TCM) for treating depression globally remains relatively low. The proposed study presents a pilot trial to evaluate the effectiveness of interventions at diffe...
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Frontiers Media S.A.
2025-02-01
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| Series: | Frontiers in Psychiatry |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyt.2025.1491410/full |
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| author | Jiaxi Mai Tingwei Zhou Tingwei Zhou Tingwei Zhou Chen Wang Chen Wang Junrong Ye Junrong Ye Jiao Chen Jiao Chen Jiao Chen Wen Wang Wen Wang Wen Wang Yuanxin Pan Yuanxin Pan Yuanxin Pan Yanheng Wei Yanheng Wei Lexin Yuan Lexin Yuan Hang Yang Hang Yang Shengwei Wu Shengwei Wu Jianxiong Guo Jianxiong Guo Jianxiong Guo Aixiang Xiao Aixiang Xiao Aixiang Xiao |
| author_facet | Jiaxi Mai Tingwei Zhou Tingwei Zhou Tingwei Zhou Chen Wang Chen Wang Junrong Ye Junrong Ye Jiao Chen Jiao Chen Jiao Chen Wen Wang Wen Wang Wen Wang Yuanxin Pan Yuanxin Pan Yuanxin Pan Yanheng Wei Yanheng Wei Lexin Yuan Lexin Yuan Hang Yang Hang Yang Shengwei Wu Shengwei Wu Jianxiong Guo Jianxiong Guo Jianxiong Guo Aixiang Xiao Aixiang Xiao Aixiang Xiao |
| author_sort | Jiaxi Mai |
| collection | DOAJ |
| description | BackgroundApproximately one-third of depressed individuals receive treatment globally. The application rate of traditional Chinese medicine (TCM) for treating depression globally remains 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.MethodsA 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), 2 weeks after intervention (T2), 4 weeks after intervention (T3), 8 weeks after intervention (T4), and 12 weeks after intervention (T5).DiscussionThis study will provide an experimental basis for the effectiveness of hierarchical integrated traditional Chinese and Western medicine (ITCWM) in improving the condition of patients with different degrees of depression. At the end of the study, it is expected for the experimental group to have an improvement in depressive symptoms and sleep quality and an enhancement in mental health awareness.Clinical trial registrationhttp://www.chictr.org.cn, identifier ChiCTR2300075169. |
| format | Article |
| id | doaj-art-8131871940814ad59158564c57c7a3d6 |
| institution | Kabale University |
| issn | 1664-0640 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychiatry |
| spelling | doaj-art-8131871940814ad59158564c57c7a3d62025-02-12T07:26:34ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402025-02-011610.3389/fpsyt.2025.14914101491410Evaluating 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 disorderJiaxi Mai0Tingwei Zhou1Tingwei Zhou2Tingwei Zhou3Chen Wang4Chen Wang5Junrong Ye6Junrong Ye7Jiao Chen8Jiao Chen9Jiao Chen10Wen Wang11Wen Wang12Wen Wang13Yuanxin Pan14Yuanxin Pan15Yuanxin Pan16Yanheng Wei17Yanheng Wei18Lexin Yuan19Lexin Yuan20Hang Yang21Hang Yang22Shengwei Wu23Shengwei Wu24Jianxiong Guo25Jianxiong Guo26Jianxiong Guo27Aixiang Xiao28Aixiang Xiao29Aixiang Xiao30Department of Science and Education, Guangzhou First People’s Hospital, Guangzhou, ChinaDepartment of Geriatric Neuroscience Center, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaCollege of Nursing, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaDepartment of Geriatric Neuroscience Center, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaDepartment of Geriatric Neuroscience Center, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaDepartment of Geriatric Neuroscience Center, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaCollege of Nursing, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaDepartment of Geriatric Neuroscience Center, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaCollege of Nursing, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaDepartment of Geriatric Neuroscience Center, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaCollege of Nursing, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaDepartment of Nursing, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaDepartment of Nursing, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaDepartment of Geriatric Neuroscience Center, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaDepartment of Traditional Chinese Medicine, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaDepartment of Traditional Chinese Medicine, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaDepartment of Chronic Diseases, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaThe Affiliated Brain Hospital, Guangzhou Medical University, Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, ChinaDepartment of Nursing, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaDepartment of Chronic Diseases, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, ChinaBackgroundApproximately one-third of depressed individuals receive treatment globally. The application rate of traditional Chinese medicine (TCM) for treating depression globally remains 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.MethodsA 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), 2 weeks after intervention (T2), 4 weeks after intervention (T3), 8 weeks after intervention (T4), and 12 weeks after intervention (T5).DiscussionThis study will provide an experimental basis for the effectiveness of hierarchical integrated traditional Chinese and Western medicine (ITCWM) in improving the condition of patients with different degrees of depression. At the end of the study, it is expected for the experimental group to have an improvement in depressive symptoms and sleep quality and an enhancement in mental health awareness.Clinical trial registrationhttp://www.chictr.org.cn, identifier ChiCTR2300075169.https://www.frontiersin.org/articles/10.3389/fpsyt.2025.1491410/fulldepressionintegrated traditional Chinese and Western treatmentsymptom gradingrandomized controlled trialsprotocols |
| spellingShingle | Jiaxi Mai Tingwei Zhou Tingwei Zhou Tingwei Zhou Chen Wang Chen Wang Junrong Ye Junrong Ye Jiao Chen Jiao Chen Jiao Chen Wen Wang Wen Wang Wen Wang Yuanxin Pan Yuanxin Pan Yuanxin Pan Yanheng Wei Yanheng Wei Lexin Yuan Lexin Yuan Hang Yang Hang Yang Shengwei Wu Shengwei Wu Jianxiong Guo Jianxiong Guo Jianxiong Guo Aixiang Xiao Aixiang Xiao Aixiang Xiao 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 Frontiers in Psychiatry depression integrated traditional Chinese and Western treatment symptom grading randomized controlled trials protocols |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | depression integrated traditional Chinese and Western treatment symptom grading randomized controlled trials protocols |
| url | https://www.frontiersin.org/articles/10.3389/fpsyt.2025.1491410/full |
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