Depression
Conditions
Keywords
depression, HRV, Tui Jing
Brief 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 pilot 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 A formal sample size estimation is not required for pilot feasibility studies because the primary objective of this study is to assess feasibility and acceptance. The sample size is estimated according to a method for preliminary pilot study. The researchers aim to recruit 36 participants to assess the feasibility of the study. 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 pilot 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 complied with 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 6 times of sham ultrasound therapy with 30 minutes each session lasting 1 month. Participants in arm A will receive 6 times of Tui Jing therapy with 30 minutes each session lasting 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 feasibility, acceptance, and satisfaction. As secondary outcomes, this study will assess changes in heart rate variability, brain activity, skin reflection, pain perception, psychological symptoms, and sleep quality. Heart rate variability will be measured using a heart rate variability monitoring device, sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and psychological symptoms will be evaluated using several related scales.
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 for 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 meeting inclusion criteria will be randomly assigned to receive either Tui Jing therapy or sham stimulation. The intervention will be conducted by a qualified therapist (with a qualification in TCM \[Master's and Bachelor's degree in Traditional Chinese medicine\]) from the Department of Rehabilitation Sciences at PolyU, while another qualified researcher will be responsible for clinical interviews, screening, and data collection.
Interventions
BEHAVIORALTui Jing 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.
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
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Screening and baseline assessments will precede the randomization process. A computerized program will generate a randomization sequence, assigning participants in a 1:1 ratio to active or sham stimulation. To ensure concealment, opaque sealed envelopes will be used, managed by a research assistant not involved in the direct handling of the study. While it is impossible to blind the therapist due to the intervention's nature, assessors will remain unaware of the treatment assignments. To evaluate the effectiveness of the blinding, participants and assessors will be asked two questions at the study's conclusion: What type of treatment do you believe you/the participant received? and How confident are you that you received active stimulation? The latter will be rated on a scale from 0 (no confidence) to 10 (very confident), aiming to measure their perceptions and confidence regarding the treatment received.
Intervention model description
A pilot 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 complied with before commencement by a person not involved in the recruitment of 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 6 times of sham ultrasound therapy with 30 minutes each session lasting 1 month.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 depression 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Rate | through study completion, an average of 6 months | Adherence Rate Formula: (Days of full protocol adherence / Total intervention days) × 100% Unit: Percentage (%) Data Source: Intervention logs |
| Recommendation Willingness Rate | through study completion, an average of 6 months | Recommendation Willingness Rate Measurement: Binary response (Yes/No) Unit: Percentage (% Yes responses) Tool: Structured interview |
| Eligibility Rate | through study completion, an average of 6 months | Eligibility Rate Formula: (Number of eligible individuals / Total screened) × 100% Unit: Percentage (%) Data Source: Screening records |
| Recruitment Rate | through study completion, an average of 6 months | Recruitment Rate Formula: (Number of consented participants / Eligible individuals) × 100% Unit: Percentage (%) Data Source: Recruitment database |
| Retention Rate | through study completion, an average of 6 months | Retention Rate Formula: (Number of completers / Enrolled participants) × 100% Unit: Percentage (%) Data Source: Follow-up records |
| Adverse Event Rate | through study completion, an average of 6 months | Adverse Event Rate Formula: (Participants reporting adverse events / Total participants) × 100% Unit: Percentage (%) Data Source: Adverse event report forms |
| Attrition Rate | through study completion, an average of 6 months | Attrition Rate Formula: (Number of withdrawals / Enrolled participants) × 100% Unit: Percentage (%) Data Source: Withdrawal documentation |
| Treatment Satisfaction | through study completion, an average of 6 months | Treatment Satisfaction Score Measurement: 10-point numerical rating scale (0 = Completely Dissatisfied, 10 = Fully Satisfied) Unit: Scale score (0-10) Tool: Standardized questionnaire |
| Intervention Liking Rate | through study completion, an average of 6 months | Intervention Liking Rate Measurement: Binary response (Yes/No) Unit: Percentage (% Yes responses) Tool: Structured interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality | From date of randomization until two weeks after the last treatment | Pittsburgh Sleep Quality Index (PSQI) Scale Range: 0-21 points Interpretation: Higher scores indicate poorer sleep quality Assessment: Standardized self-report questionnaire |
| Sleep Efficiency | From date of randomization until two weeks after the last treatment | 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 |
| Subjective Sleep Quality | From date of randomization until two weeks after the last treatment | Measurement: 10-point Likert scale (1 = Very Poor, 10 = Excellent) Unit: Scale score (1-10) Tool: Standardized sleep diary |
| Heart Rate Variability (HRV) | through study completion, an average of 6 months | 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: 10-minute resting-state measurement |
| Skin Reactions | through study completion, an average of 6 months | 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) Quality Control: Imaging environment: Standardized D65 lighting Analysis software: IBOOLO SkinAnalyzer Pro v3.2 |
| Psychological outcomes - Depression symptoms | through study completion, an average of 6 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, monthly during intervention, post-intervention |
Countries
Hong Kong
Outcome results
None listed