Abstract
BackgroundDepression 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/designThis 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.DiscussionThe 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 registrationChinese Clinical Trial Registry ChiCTR1900028289. Registered on 17 December 2019
Highlights
Depression is seriously affecting the physical and mental health of young people worldwide
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
Summary
It is widely believed in the academic community that practicing Tai Chi is of great benefit to promoting and maintaining physical and mental health [17]. A return visit at 12 weeks after the end of the intervention was conducted to observe the longterm effects of Tai Chi training on young adults with subthreshold depression This trial may have some potential limitations. This study is the first randomized controlled trial to systematically evaluate the influence of traditional Tai Chi for patients with subthreshold depression from the perspective of subjective and objective indicators. If this trial exhibits significant results, a shred of rigorous evidence could be provided for the application of Tai Chi training among young adults with subthreshold depression, as well as a new way to prevent and reduce the global burden of MDD. Response; fMRI: Functional magnetic resonance imaging; p-CRF: Paper case report form; e-CRF: Electronic case report form
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