RecruitingNot ApplicableNCT07449676

Effects of an Innovative TCM-based Tui Jing Therapy on Psychological and Neurophysiological Functions in Depression

Effects of an Innovative TCM-based Tui Jing Therapy on Psychological and Neurophysiological Functions in Depression: A Randomized Controlled Study

Sponsor

The Hong Kong Polytechnic University

Enrollment

64 participants

Start Date

Feb 28, 2026

Study Type

INTERVENTIONAL

Conditions

Depression

Summary

Background: Mental disorders are recognized as a major cause of disability and disease burden across the lifespan. Gua Sha is believed to improve mental health and sleep quality significantly. Tui Jing is an innovative type of Gua Sha therapy that penetrates deep into the muscles and fascia rather than just acting on the surface of the skin. Modern research has revealed that Gua Sha is extensively utilized for pain-related symptoms, and its therapeutic effects may be attributed to anti-inflammatory and immunomodulatory mechanisms. Although Gua Sha has demonstrated efficacy in treating various diseases, limited research exists regarding its impact and underlying mechanisms on mental health. This study will conduct a clinical trial to assess the efficacy of Tuijing Therapy on mental health. Autonomic function is closely associated with psychological symptoms, and HRV reflects the activation of the vagus nerve. This study aims to obtain preliminary evidence that Gua Sha can modulate HRV by regulating vagal function, potentially ameliorating psychological disorders. Population: The sample size is estimated using G\*power, and a total of 64 participants are needed. Adults without any chronic diseases who score over 14 on the HAM-D 17 and have no smoking or drinking habits will be included. Method: A randomized controlled study will be conducted with Tuijing therapy as the intervention and sham therapy as the control. The intervention group will receive the actual intervention, while the sham intervention group will undergo a sham ultrasound treatment process that does not involve the active therapeutic components. A computer-generated random allocation schedule will be compiled before commencement by a researcher not involved in recruiting participants. Tuijing therapy will be administered as arm A, while the sham control group will serve as arm B. There will be a 5-day interval between interventions. Participants in arm B will receive 4 sessions of sham ultrasound therapy, with 45 minutes for 1 month. Participants in arm A will receive 4 sessions of Tui Jing therapy for 45 minutes for 1 month. Heart rate variability, brain activity, skin reflection, pain perception, psychological symptoms, and sleep quality will be assessed as outcome measures. Outcomes: The primary outcomes of this study are the efficacy of Tui Jing therapy on depressive symptoms. As secondary outcomes, this study will assess changes in heart rate variability, brain activity, skin reflection, stress and anxiety symptoms, and sleep quality. Heart rate variability will be measured using a heart rate variability monitoring device, and brain activity will be measured by fNIRS. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Stress and anxiety symptoms will be evaluated using the Depression Anxiety Stress Scales (DASS).

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an innovative Traditional Chinese Medicine (TCM)-based massage therapy called Tui Jing on psychological and brain function in people with depression. The therapy uses specific massage techniques along meridian pathways in the body. The study will measure psychological outcomes and brain activity to see if this non-drug approach can help with depressive symptoms. **You may be eligible if:** - You are between 18 and 55 years old - You are willing to be randomly assigned to a treatment group - You are proficient in Chinese - You have been experiencing depressive symptoms for more than 3 months - Your score on the Hamilton Depression Rating Scale is above 14 (indicating at least moderate depression) - You scored 20 or higher on a cognitive assessment (MoCA) **You may NOT be eligible if:** - You have cardiovascular disease - You have had a serious head injury, elevated brain pressure, metal implants in your body, or a history of epilepsy - You have taken any medications or undergone other treatments for depression in the past month - You have a skin condition or easily injured skin - You have any form of cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERmanual therapy: Tui Jing therapy

(Gua Sha + Meridian pressure) was utilized, a specialized form of Gua Sha that incorporates traditional techniques with targeted pressure on specific meridians.

DEVICEsham ultrasound intervention

Participants will receive a sham ultrasound intervention on the same meridians. To enhance comfort and prevent cold sensations from the metal probe, the ultrasound device will be pre-warmed to body temperature. A gel, mimicking the texture of the lubricant used in Tui Jing therapy, will be applied. The device will mimic the motion, direction, duration, and frequency of the Tui Jing therapy, but without activating the ultrasound's therapeutic mode. The participants will be informed that they are accepting low-intensity ultrasound mode, which will not produce any sensory perception, ensuring in distinguishing ability between active and sham interventions