AUTHOR=Chen Jing , Shen Ke , Fan Lijuan , Hu Hantong , Li Tieniu , Zhang Yiting , Gao Hong 

TITLE=Integrative medicine in treating post-stroke depression: Study protocol for a multicenter, prospective, randomized, controlled trial

JOURNAL=Frontiers in Psychology

VOLUME=Volume 13 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.923506

DOI=10.3389/fpsyg.2022.923506

ISSN=1664-1078

ABSTRACT=Background: Post-stroke depression (PSD) is one of the most common neuropsychiatric diseases in stroke patients, which can increase the disability rate, mortality and recurrence rate of stroke. At present, many clinical studies have indicated that traditional Chinese medicine (TCM) such as acupuncture and herbs, Western medicine, rehabilitation, repeated transcranial magnetic stimulation and other treatment methods are effective for PSD. However, there is no study to formulate a comprehensive treatment plan that integrates TCM, Western medicine and rehabilitation for post-stroke depression. Thus, this trial aims to assess the efficacy and safety of integrative medicine on PSD.
Methods: This is a multicenter, prospective, randomized, controlled study to form a set of effective clinical treatment scheme, which integrates TCM, Western medicine and rehabilitation for PSD. A total of 202 participants recruited from 4 centers will be randomized into either the integrative medicine group or the standard care group. With basic treatment, general nursing and exercise therapy in both groups, the integrative medicine group will receive acupuncture, Chinese herbs, and repeated transcranial magnetic stimulation. Participants will receive treatments for 4 weeks. The primary outcomes are Hamilton Depression Scale, Self-Rating Depression Scale, and Activity of Daily Living Scale, and the secondary outcomes are Montreal Cognitive Assessment Scale, the simple Fugl-Meyer Assessment of Motor Function Scale and Pittsburgh Sleep Quality Index. At baseline, week 4 (the end of treatment courses), and week 8 (the end of follow-up), all outcome measures will be evaluated. Safety assessments will be performed throughout the study.
Discussion: The present study is expected to verify the efficacy and safety of integrative medicine for treating PSD, which will offer an evidence-based clinical reference for the future development of a standardized and popularized scheme.
Trial registration: ClinicalTrials.gov Identifier: NCT05187975, registration date: January 12, 2022.