太极拳对亚临床抑郁的年轻成年人抑郁症状的有效性：一项随机对照试验的研究方案。
The effectiveness of Tai Chi on the depressive symptom of young adults with subthreshold depression: a study protocol for a randomized controlled trial.
机构信息
Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.
Key Laboratory of Orthopedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fu Jian university of TCM), Ministry of Education, Fuzhou, 350122, China.
出版信息
Trials. 2021 Jan 30;22(1):106. doi: 10.1186/s13063-021-05054-6.
BACKGROUND
Depression is seriously affecting the physical and mental health of young people worldwide. Subthreshold depression, as an early stage of depression, is essential for early prevention and treatment of depression. Tai Chi, as a traditional Chinese mind-body therapy, may become an alternative intervention. However, the neurophysiological mechanism of Tai Chi for young people with subthreshold depression remains unclear, restricting its further promotion and application. Therefore, rigorous randomized clinical trials are needed to further observe the intervention effect of Tai Chi on young adults with subthreshold depression and explore the neurophysiological mechanism.
METHOD/DESIGN: This report describes a two-arm, randomized, parallel controlled trial with allocation concealment and assessor blinding. A total of 64 eligible participants are randomly allocated to the Tai Chi group and the waiting list group in a 1:1 ratio. Participants in the Tai Chi group receive 12 weeks of Tai Chi training, with a total of 36 times and each for 60 min. Specifically, the participants in the waiting list group are requested to maintain their routine lifestyle. In this study, the primary outcome measure is the mean change in scores on the PHQ-9 and HAMD-17 between baseline and 12 weeks; the secondary outcomes are the mean change in the scores on CES-D, CPSS, GAD-7, and PSQI. Besides, the saliva cortisol levels and fMRI are monitored to explore the mechanism of action of Tai Chi on subthreshold depression.
DISCUSSION
The protocol uses a randomized controlled trial to examine the effectiveness of Tai Chi for young adults with subthreshold depression and explore neurophysiological mechanisms. If the test results are positive, it can be verified that Tai Chi can promote the physical and mental health of young adults with subthreshold depression.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR1900028289 . Registered on 17 December 2019.
背景
抑郁症严重影响着全球年轻人的身心健康。阈下抑郁作为抑郁的早期阶段，对于抑郁的早期预防和治疗至关重要。太极拳作为一种传统的身心疗法，可能成为一种替代干预措施。然而，阈下抑郁青年进行太极拳干预的神经生理机制尚不清楚，限制了其进一步的推广和应用。因此，需要严格的随机临床试验来进一步观察太极拳对阈下抑郁青年的干预效果，并探讨其神经生理机制。
方法/设计：本报告描述了一项两臂、随机、平行对照、设盲、分配隐藏的临床试验。共纳入 64 名符合条件的参与者，按照 1:1 的比例随机分配至太极拳组和等待名单组。太极拳组接受 12 周的太极拳训练，共 36 次，每次 60 分钟。具体来说，等待名单组被要求保持其日常生活方式。本研究的主要结局指标是 PHQ-9 和 HAMD-17 评分在基线和 12 周时的平均变化；次要结局指标是 CES-D、CPSS、GAD-7 和 PSQI 评分的平均变化。此外，监测唾液皮质醇水平和 fMRI 以探讨太极拳对阈下抑郁作用的机制。
讨论
该方案采用随机对照试验来检验太极拳对阈下抑郁青年的有效性，并探讨其神经生理机制。如果试验结果为阳性，则可以验证太极拳可以促进阈下抑郁青年的身心健康。
试验注册
中国临床试验注册中心 ChiCTR1900028289 。注册于 2019 年 12 月 17 日。
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