DepressionTJNCT07449676
Effects of an Innovative TCM-based Tui Jing Therapy on Psychological and Neurophysiological Functions in Depression
A study testing manual therapy: Tui Jing therapy in people with Depression, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depression
- What is being tested?
- manual therapy: Tui Jing therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Feb 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong, Hung Hom
Zoey Yutong Li, 22117903r@connect.polyu.hk
About this study
Official title: Effects of an Innovative TCM-based Tui Jing Therapy on Psychological and Neurophysiological Functions in Depression: A Randomized Controlled Study
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).
Read the detailed description
Procedures: The researcher will conduct an initial telephone interview to provide study information and screen potential participants for eligibility. Each participant will receive full details about the study's purpose and will be required to sign an informed consent form. All participants will be invited to two in-person sessions before accepting any intervention. In the first session, comprehensive medical histories, brief semi-structured interviews for psychological symptoms, clinical examinations, general information, and questionnaires will be conducted to determine eligibility. Eligible participants in the first session will be included in the second session. The second session will be scheduled to collect baseline data for further analysis. Eligible participants who meet the inclusion criteria will be randomly assigned to receive either Tui Jing therapy or sham stimulation. The intervention will be conducted by a qualified therapist (Registered Chinese Medicine Practitioner in Hong Kong) from the Department of Rehabilitation Sciences at PolyU, while another qualified researcher will be responsible for clinical interviews, screening, and data collection.
- Conditions
- Depression
- Being tested
- manual therapy: Tui Jing therapy, sham ultrasound intervention
- Keywords
- depression, Tui Jing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapy: Tui Jing therapyOther
(Gua Sha + Meridian pressure) was utilized, a specialized form of Gua Sha that incorporates traditional techniques with targeted pressure on specific meridians.
sham ultrasound interventionDevice
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
| Study group | Role | What they receive |
|---|---|---|
| The Tui Jing Group | Experimental | Tui Jing group: A standardized treatment protocol targeting specific meridians identified in traditional Chinese medicine will be followed. Designed specifically for psychological symptoms, the protocol involves bilateral therapy on four key meridians. These include the Hand Shaoyin Heart Meridian, Hand Jueyin Pericardium Meridian, Foot Taiyin Spleen Meridian, and Foot Jueyin Liver Meridian. Receives: Other: manual therapy: Tui Jing therapy |
| The Sham ultrasound control | Sham comparator | Participants will receive a sham ultrasound control 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 turning on 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 they cannot distinguish between the active and the sham interventions. Receives: Device: sham ultrasound intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological outcomes - Depression symptoms
Hamilton Depression Rating Scale (HAMD-17) Scale Range: 0-52 points Interpretation: Higher scores indicate greater depression severity Assessment: Semi-structured interview by trained raters Time Frame: Baseline, post-intervention, and two-week follow-up.
Measured: through study completion, an average of 12 months
Psychological outcomes - Depression symptoms
Patient Health Questionnaire (PHQ-9) Scale Range: 0-27 points Interpretation: Higher scores indicate greater depression severity Assessment: Self-administered questionnaire
Measured: through study completion, an average of 12 months
Secondary outcomes (7)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) Scale Range: 0-21 points Interpretation: Higher scores indicate poorer sleep quality Assessment: Standardized self-report questionnaire
Measured: From the date of randomization until two weeks after the last treatment
Psychological outcomes - stress and anxiety
The Depression Anxiety Stress Scale (DASS) is a set of self-report questionnaires designed to measure the severity of negative emotional symptoms.
Scale Range: 0-63 points. Interpretation: Higher scores indicate greater symptom severity. Anxiety: Normal (0-7), Mild (8-9), Moderate (10-14), Severe (15-19), Extremely Severe (20+).
Stress: Normal (0-14), Mild (15-18), Moderate (19-25), Severe (26-33), Extremely Severe (34+)
Measured: From the date of randomization until two weeks after the last treatment
Sleep Efficiency
Objective Sleep Efficiency Measurement: (Total sleep time / Time in bed) × 100% Unit: Percentage (%). Tool: Fitbit Inspire 2 (FDA-cleared wearable device). Data Collection: Automated daily sync to the research platform.
Measured: From the date of randomization until two weeks after the last treatment
Subjective Sleep Quality and duration
Measurement: 10-point Likert scale (1 = "Very Poor", 10 = "Excellent") Unit: Scale score (1-10) Measurement: self-report sleep duration Tool: Standardized sleep diary
Measured: From the date of randomization until two weeks after the last treatment
Heart Rate Variability (HRV)
Metrics: RMSSD (Root Mean Square of Successive Differences), SDNN (Standard Deviation of NN Intervals), Low Frequency (LF: 0.04-0.15 Hz), High Frequency (HF: 0.15-0.40 Hz). Unit: Milliseconds (ms) Tool: NeXus-10 Biofeedback System (Mind Media) Protocol: 5-minute pre and post resting-state measurement; Task measurement (Cognitive neuroscience around 17 min); Synchronous measurement during intervention.
Measured: through study completion, an average of 12 months
Skin Reactions
Skin Discoloration Severity Measurement Protocol: Capture multispectral images using the IBOOLO DE-4100 system. Calculate the ΔContrast between affected and normal skin areas. Formula: ΔContrast = |Mean lesion chroma value - Mean normal skin chroma value|.
Unit: Standardized chroma difference (0-100; 0=no difference, 100=maximal difference). Dimensionless relative units (a.u.) or standardized relative changes will be used. Quality Control: Imaging environment: Standardized D65 lighting, Analysis software: IBOOLO SkinAnalyzer Pro v3.2
Measured: through study completion, an average of 12 months
Brain activity
Brain activity measurement: Human brain mapping using the NIRSport 2, a functional near-infrared spectroscopy (fNIRS) platform, is used to measure cerebral hemodynamics using a non-invasive method. This detection is determined by two types of near-infrared wavelength spectroscopy (NIRS). By reflecting near-infrared light off the cerebral tissue, information on tissue oxygenation and metabolism can be obtained. Tools : Specifications:
- Measurements: changes in oxyhemoglobin and deoxyhemoglobin concentration
- Light source: high-powered dual LEDs
- Wavelengths: 760 nm and 850 nm
- Number of emitters: 16
- Number of detectors: 16
- Fiber holder configurations: freely configurable based on the 10-20 system The unit of fNIRS measurement results is the change in molar concentration, expressed as (micromoles/liter/mm).
Protocol: 5-minute pre and post resting-state measurement; Task measurement (Cognitive neuroscience around 17 min); Synchronous measurement during intervention.
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start28 Feb 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled study will be conducted with Tui Jing 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 person not involved in the recruitment of participants. Tui Jing 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449676
- Sponsor's protocol ID
- 2026-TJ
- Other IDs
- ZH3P
- Acronym
- TJ
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Confidentiality Agreement
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Innovative TCM-based Tui Jing Therapy on Psychological and Neurophysiological Functions in Depression: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07449676
- Acronym / sponsor ID
- TJ / 2026-TJ
- Conditions
- Depression
- Keywords
- depression, Tui Jing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Procedures: The researcher will conduct an initial telephone interview to provide study information and screen potential participants for eligibility. Each participant will receive full details about the study's purpose and will be required to sign an informed consent form. All participants will be invited to two in-person sessions before accepting any intervention. In the first session, comprehensive medical histories, brief semi-structured interviews for psychological symptoms, clinical examinations, general information, and questionnaires will be conducted to determine eligibility. Eligible participants in the first session will be included in the second session. The second session will be scheduled to collect baseline data for further analysis. Eligible participants who meet the inclusion criteria will be randomly assigned to receive either Tui Jing therapy or sham stimulation. The intervention will be conducted by a qualified therapist (Registered Chinese Medicine Practitioner in Hong Kong) from the Department of Rehabilitation Sciences at PolyU, while another qualified researcher will be responsible for clinical interviews, screening, and data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled study will be conducted with Tui Jing 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 person not involved in the recruitment of participants. Tui Jing 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.
| Arm | Type | Receives |
|---|---|---|
| The Tui Jing Group | Experimental | Other: manual therapy: Tui Jing therapyTui Jing group: A standardized treatment protocol targeting specific meridians identified in traditional Chinese medicine will be followed. Designed specifically for psychological symptoms, the protocol involves bilateral therapy on four key meridians. These include the Hand Shaoyin Heart Meridian, Hand Jueyin Pericardium Meridian, Foot Taiyin Spleen Meridian, and Foot Jueyin Liver Meridian. |
| The Sham ultrasound control | Sham comparator | Device: sham ultrasound interventionParticipants will receive a sham ultrasound control 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 turning on 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 they cannot distinguish between the active and the sham interventions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual 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. | Other | The Tui Jing Group |
| sham ultrasound interventionParticipants 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 | Device | The Sham ultrasound control |
Primary outcome
Psychological outcomes - Depression symptoms
Time frame: through study completion, an average of 12 months
Hamilton Depression Rating Scale (HAMD-17) Scale Range: 0-52 points Interpretation: Higher scores indicate greater depression severity Assessment: Semi-structured interview by trained raters Time Frame: Baseline, post-intervention, and two-week follow-up.
Psychological outcomes - Depression symptoms
Time frame: through study completion, an average of 12 months
Patient Health Questionnaire (PHQ-9) Scale Range: 0-27 points Interpretation: Higher scores indicate greater depression severity Assessment: Self-administered questionnaire
7 secondary outcomes
Sleep quality
Time frame: From the date of randomization until two weeks after the last treatment
Psychological outcomes - stress and anxiety
Time frame: From the date of randomization until two weeks after the last treatment
Sleep Efficiency
Time frame: From the date of randomization until two weeks after the last treatment
Subjective Sleep Quality and duration
Time frame: From the date of randomization until two weeks after the last treatment
Heart Rate Variability (HRV)
Time frame: through study completion, an average of 12 months
Skin Reactions
Time frame: through study completion, an average of 12 months
Brain activity
Time frame: through study completion, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided. Confidentiality Agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual therapy: Tui Jing therapy in people with Depression, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yutong Li (852 61917986, zoeyo.li@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological outcomes - Depression symptoms (time frame: through study completion, an average of 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.