Acupuncture for Adolescent Depression Disorder: protocol for a randomized controlled trial.

Background: Adolescent Depression Disorder (ADD) is a disease with a high rate of disability and death worldwide, and its incidence is increasing, seriously influencing the physical and mental health of adolescents. Acupuncture is a complementary alternative therapy that has achieved good clinical efficacy in the intervention of depression, but its efficacy in ADD is uncertain. Therefore, the aim of this pilot trial is to preliminarily explore the possibility of acupuncture in the treatment of ADD, and to evaluate the feasibility of conducting further large-scale clinical trials to verify the efficacy of acupuncture. Methods: In this pilot randomized controlled trial, 60 participants will be randomly assigned to receive acupuncture or sham acupuncture for 8 weeks of treatment and 4 weeks of follow-up. The primary outcome will be the difference in Children's Depression Rating Scale-revised (CDRS-R) scores at weeks 0 and 8 of treatment. Secondary outcomes will include 17-item Hamilton Depression Scale (HAMD-17) clinical score reduction rate and clinical remission rate, difference in CDRS-R scores, HAMD-17 scores, 14-item Hamilton Depression Scale (HAMD-14) scores, Pittsburgh Sleep Quality Index scale (PSQI) scores, and Columbia-Suicide Severity Rating Scale (C-SSRS) scores. All outcomes will be assessed at weeks 0, 2, 4, 6, 8 of treatment and week 12 of the follow-up period. In addition, we will assess the safety outcomes from baseline to the end of this trial and feasibility outcome after treatment. Ethics and dissemination: The trial protocol is in accordance with the principles of the Declaration of Helsinki, and has been approved by the Ethics Committee of the Affiliated Traditional Chinese Medicine Hospital, Guangzhou Medical University (approval number 2024NK73). The results of this trial will be made publicly available on the registration platform. Professional writers will not be used for this trial. Future authorship of trial publications will be based on the authors' contributions. Discussion: The results of this study will provide information on the efficacy and safety of acupuncture in the treatment of add, and evaluate the feasibility of acupuncture in the treatment of add, which will provide the basis for further clinical intervention and scientific research. Clinical Trial Registration: http://itmctr.ccebtcm.org.cn/zh-CN/UserPlatform/ProjectView?pid=730cb4d2-3634-4789-a51d-85a20514aa0a, identifier ITMCTR2024000186.