An interventional study of TCM Daoyin exercise in Anxiety Symptom and Depression Symptom, sponsored by Shanghai University of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Shanghai University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
This 12-week single-arm clinical trial investigates the effects of Traditional Chinese Medicine (TCM) Daoyin exercise on anxiety and depression symptoms in 20 participants, followed by a 12-week observational follow-up period.
The primary outcome is the change in Hamilton Anxiety Rating Scale (HAMA-14) and Hamilton Depression Rating Scale (HAMD-17) scores at 12 weeks. A secondary outcome will assess these scores at 24 weeks to evaluate sustained effects. Additional secondary outcomes include the Depression, Anxiety, and Stress Scale (DASS-21) and Pittsburgh Sleep Quality Index (PSQI) to further assess changes in mood and sleep quality at the same time points.
Exploratory analyses will examine inflammatory markers, immune cell subsets, serum metabolomics, and gut microbiota at baseline, 12 weeks, and 24 weeks to identify potential biological correlates. During the follow-up period, participants will record their actual exercise engagement, allowing investigators to explore long-term associations. Findings may provide insights for future mechanistic studies on TCM's role in mental health.
Anxiety and depression are among the most prevalent mental health conditions and are commonly associated with inflammation, immune dysregulation, and metabolic disturbances. Traditional Chinese Medicine (TCM) interventions, such as Daoyin exercise-a form of guided movement and breathing-have historically been used to promote mental well-being. However, their biological mechanisms remain inadequately understood.
This 12-week, single-arm clinical trial aims to evaluate the effects of a structured Daoyin exercise program on subclinical anxiety and depression symptoms in 20 adult participants. After completing the 12-week intervention, participants will enter a 12-week observational follow-up period, during which they may choose to continue or discontinue the practice at their discretion. Actual exercise engagement during the follow-up will be self-recorded using daily logs.
The primary outcome is the change in Hamilton Anxiety Rating Scale (HAMA-14) and Hamilton Depression Rating Scale (HAMD-17) scores from baseline to 12 weeks. A secondary outcome will assess the persistence of these effects at 24 weeks. Additional psychological assessments include the Depression, Anxiety, and Stress Scale (DASS-21) and the Pittsburgh Sleep Quality Index (PSQI), evaluated at baseline, 12 weeks, and 24 weeks to assess broader changes in mood and sleep quality.
Exploratory outcomes will investigate potential biological mechanisms by measuring:
Samples will be collected at baseline, 12 weeks, and 24 weeks. These data will help identify physiological pathways potentially linked to improvements in anxiety and depression symptoms.
Participants will be included based on clinician assessment and confirmed subclinical symptoms, with HAMA-14 scores between 14-29 and HAMD-17 scores between 7-14, without meeting ICD-10 diagnostic criteria for anxiety or depressive disorders. All psychological and biological evaluations will occur at three time points: baseline, post-intervention (12 weeks), and follow-up (24 weeks).
The results may offer preliminary evidence for integrating Daoyin exercise into mental health self-management strategies and provide a foundation for future research into TCM's biological mechanisms.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 20 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 102 studies on the registry; 20 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a 12-week TCM Daoyin training program led by qualified physicians. Structured group sessions will incorporate movement regulation, breath regulation, and mind regulation to alleviate anxiety and depression symptoms.
Behavioral: TCM Daoyin exercise
Participants will receive a 12-week, group-based TCM Daoyin intervention consisting of two 90-minute sessions per week (total: 24 sessions), led by qualified physicians. Each session integrates movement regulation, breath regulation, and mind regulation, aiming to alleviate anxiety and depression symptoms. Each session includes a 10-minute warm-up and a 10-minute cool-down. Compliance and Analysis: Per-protocol analysis will include participants who attend ≥80% of sessions (≥19/24 sessions). Safety analyses will be conducted on all enrolled participants (n=20) following the intention-to-treat (ITT) principle.
14-item Hamilton Anxiety Rating Scale (HAMA-14)
The 14-item Hamilton Anxiety Rating Scale (HAMA-14) is a clinician-rated assessment (structured interview) of patients' anxiety symptoms. The scale evaluates symptoms experienced over the past 7 days, with higher cumulative scores indicating more severe anxiety. Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 56, with severity levels categorized as follows: * ≥29: Severe anxiety disorder * 21-28: Marked anxiety disorder * 14-20: Anxiety disorder * 8-13: Suspected anxiety disorder * ≤7: No anxiety disorder
Time frame: Change from Baseline at 12 weeks
17-item Hamilton Depression Rating Scale (HAMD-17)
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated assessment (structured interview) of patients' depressive symptoms. The scale assesses symptoms over the past 7 days, with higher cumulative scores indicating more severe depression. Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 52, with severity levels categorized as follows: * ≥25: Severe depression disorder * 18-24: Moderate depression * 13-17: Mild depression disorder * 8-12: Suspected depression disorder * ≤7: No depression disorder
Time frame: Change from Baseline at 12 weeks
14-item Hamilton Anxiety Rating Scale (HAMA-14)
The 14-item Hamilton Anxiety Rating Scale (HAMA-14) is a clinician-rated assessment (structured interview) of patients' anxiety symptoms. The scale evaluates symptoms experienced over the past 7 days, with higher cumulative scores indicating more severe anxiety. Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 56, with severity levels categorized as follows: * ≥29: Severe anxiety disorder * 21-28: Marked anxiety disorder * 14-20: Anxiety disorder * 8-13: Suspected anxiety disorder * ≤7: No anxiety disorder
Time frame: Change from 12 weeks to 24 weeks
14-item Hamilton Anxiety Rating Scale (HAMA-14)
The 14-item Hamilton Anxiety Rating Scale (HAMA-14) is a clinician-rated assessment (structured interview) of patients' anxiety symptoms. The scale evaluates symptoms experienced over the past 7 days, with higher cumulative scores indicating more severe anxiety. Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 56, with severity levels categorized as follows: * ≥29: Severe anxiety disorder * 21-28: Marked anxiety disorder * 14-20: Anxiety disorder * 8-13: Suspected anxiety disorder * ≤7: No anxiety disorder
Time frame: Change from Baseline to 24 weeks
17-item Hamilton Depression Rating Scale (HAMD-17)
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated assessment (structured interview) of patients' depressive symptoms. The scale assesses symptoms over the past 7 days, with higher cumulative scores indicating more severe depression. Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 52, with severity levels categorized as follows: * ≥25: Severe depression disorder * 18-24: Moderate depression * 13-17: Mild depression disorder * 8-12: Suspected depression disorder * ≤7: No depression disorder
Time frame: Change from 12 weeks to 24 weeks
17-item Hamilton Depression Rating Scale (HAMD-17)
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated assessment (structured interview) of patients' depressive symptoms. The scale assesses symptoms over the past 7 days, with higher cumulative scores indicating more severe depression. Each item is rated on a 5-point scale from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 52, with severity levels categorized as follows: * ≥25: Severe depression disorder * 18-24: Moderate depression * 13-17: Mild depression disorder * 8-12: Suspected depression disorder * ≤7: No depression disorder
Time frame: Change from Baseline to 24 weeks
The Depression, Anxiety, and Stress Scale-21 (DASS-21)
The DASS-21 is a self-reported assessment used to measure the severity of depression, anxiety, and stress symptoms experienced by individuals over the past week. Higher cumulative scores on each subscale indicate more severe symptoms of depression, anxiety, or stress. The DASS-21 includes three subscales, each with 7 items: one for depression, one for anxiety, and one for stress. Each item is rated on a 4-point scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Subscale scores are calculated by summing the responses to the seven items in each subscale and multiplying the total by 2. The following cutoff values are used to categorize symptom severity: * Depression: A score greater than 9 indicates mild to severe depression. * Anxiety: A score greater than 7 indicates mild to severe anxiety. * Stress: A score greater than 14 indicates mild to severe stress.
Time frame: Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI consists of 19 self-rated items and 5 items rated by a roommate or bed partner. The 19th self-rated item and the 5 items rated by others are not included in the scoring. The remaining 18 self-rated items are grouped into 7 components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, with higher scores indicating worse sleep quality. The total score is the sum of the 7 components, with a range of 0 to 21. It is used to assess the participant's subjective sleep quality over the past month, where higher scores indicate poorer sleep quality.
Time frame: Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
Changes in Inflammatory Markers
Changes in inflammatory markers (e.g., interleukin-10 \[IL-10\], interleukin-6 \[IL-6\], tumor necrosis factor-alpha \[TNF-α\]) from baseline to 12 weeks and 24 weeks to explore the potential biological mechanisms underlying the effects of Daoyin exercise on anxiety and depression.
Time frame: Change from Baseline at 12 weeks and 24 weeks
Changes in Immune Cell Subsets
Changes in immune cell subsets (e.g., cluster of differentiation 3-positive \[CD3+\], cluster of differentiation 4-positive \[CD4+\], cluster of differentiation 8-positive \[CD8+\] T cells) from baseline to 12 weeks and 24 weeks to explore the potential biological mechanisms underlying the effects of Daoyin exercise on anxiety and depression.
Time frame: Change from Baseline at 12 weeks and 24 weeks
Changes in Serum Metabolomics
Changes in serum metabolomics from baseline to 12 weeks and 24 weeks to explore the potential biological mechanisms underlying the effects of Daoyin exercise on anxiety and depression.
Time frame: Change from Baseline at 12 weeks and 24 weeks
Changes in Gut Microbiota
Changes in gut microbiota from baseline to 12 weeks and 24 weeks to explore the potential biological mechanisms underlying the effects of Daoyin exercise on anxiety and depression.
Time frame: Change from Baseline at 12 weeks and 24 weeks
Plan to share: No
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Started Apr 2025 (actual). Primary completion is estimated for Mar 2027, 23 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 23 months is close to that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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