Author: Xiaoting Xie#1,2, Jian Song#1,2,3, Jingfang Zhu1,2,3, Mengyu Han1,2, Youze He1,2, Jia Huang1,2,3,4, Jing Tao1,2,3,4, Jingsong Wu5,6,7,8
Affiliation: <sup>1</sup> Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.
<sup>2</sup> Key Laboratory of Orthopedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fu Jian university of TCM), Ministry of Education, Fuzhou, 350122, China.
<sup>3</sup> Fujian Collaborative Innovation Center for Rehabilitation Technology, Fuzhou, 350122, China.
<sup>4</sup> TCM Rehabilitation Research Center Of SATCM, Fuzhou, 350122, China.
<sup>5</sup> Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China. jingsongwu01@163.com.
<sup>6</sup> Key Laboratory of Orthopedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fu Jian university of TCM), Ministry of Education, Fuzhou, 350122, China. jingsongwu01@163.com.
<sup>7</sup> Fujian Collaborative Innovation Center for Rehabilitation Technology, Fuzhou, 350122, China. jingsongwu01@163.com.
<sup>8</sup> TCM Rehabilitation Research Center Of SATCM, Fuzhou, 350122, China. jingsongwu01@163.com.
Conference/Journal: Trials
Date published: 2021 Jan 30
Other:
Volume ID: 22 , Issue ID: 1 , Pages: 106 , Special Notes: doi: 10.1186/s13063-021-05054-6. , Word Count: 303
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.
Keywords: HPA; Randomized controlled trial; Subthreshold depression; Tai Chi; Young adults.
PMID: 33516240 DOI: 10.1186/s13063-021-05054-6