Effects of an Innovative TCM-based Tui Jing Therapy on Psychological and Neurophysiological Functions in Depression
Recruiting · NCT07449676 · Interventional (participants receive a specific treatment) · Lead sponsor: The Hong Kong Polytechnic University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- Age 18 - 55 years old
- Willingness to participate in the study and undergo randomization
- Proficiency in Chinese
- Absence of severe chronic diseases
- Experience with depressive symptoms for over three months
- Scoring 20 or higher on the Montreal Cognitive Assessment (MoCA)
- Scoring above 14 on the Hamilton Depression Rating Scale 17
Exclusion criteria
- The presence of cardiovascular disease (CVD)
- Severe head trauma, intracranial hypertension, implanted ferromagnetic devices, or a history of epilepsy
- Engagement in any pharmacological or non-pharmacological treatments within the past month
- Existing skin conditions or susceptibility to skin injuries
- Any form of cognitive impairment
Where it is running
1 location listed.
- The Hong Kong Polytechnic University - Hong Kong, Hung Hom, Hong Kong