TCM Daoyin for Anxiety/Depression: Psychological Effects and Biological Mechanisms

NCT06921512 | Recruiting

• 1 other identifier: 24KFL060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression Symptom; Anxiety Symptom

Keywords

Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Change from Baseline at 12 weeks

Secondary Outcomes (10)

• 14-item Hamilton Anxiety Rating Scale (HAMA-14)

  Change from 12 weeks to 24 weeks

• 14-item Hamilton Anxiety Rating Scale (HAMA-14)

  Change from Baseline to 24 weeks

• 17-item Hamilton Depression Rating Scale (HAMD-17)

  Change from 12 weeks to 24 weeks

• 17-item Hamilton Depression Rating Scale (HAMD-17)

  Change from Baseline to 24 weeks

• The Depression, Anxiety, and Stress Scale-21 (DASS-21)

  Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.

Study Arms (1)

TCM Daoyin Exercise Group

EXPERIMENTAL

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

Interventions

TCM Daoyin exercise BEHAVIORAL

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.

TCM Daoyin Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary symptoms of anxiety and depression, with a Hamilton Anxiety Rating Scale (HAMA-14) score between 14 and 29 and a Hamilton Depression Rating Scale (HAMD-17) score between 7 and 14.
• No prior use of psychotropic medication, or at least six months since discontinuation.
• Aged 18 to 65 years (male or female).
• Clear consciousness and normal cognitive function, with the ability to communicate effectively, read, express thoughts, and engage in daily activities independently.
• Willing and able to comply with blood and stool sample collection.
• Voluntary participation, with signed informed consent provided before enrollment.

You may not qualify if:

• Diagnosed anxiety disorder or depressive disorder based on ICD-10 criteria.
• Bipolar disorder, psychotic disorders (e.g., schizophrenia), or organic mental disorders (e.g., Alzheimer's disease).
• History of alcohol or substance use disorder within the past year, current psychiatric medication use, or high suicide risk.
• Severe or unstable medical conditions, including immune or endocrine disorders or other serious illnesses.
• Physical or psychological limitations preventing participation in the TCM Daoyin intervention.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Shanghai Mental Health Center: collaborator

Study Sites (1)

Shanghai Qigong Research Institute

Shanghai, 200030, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Ying Lu, Master

  Shanghai Qigong Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Lu, Master

CONTACT

021-64394141; luyingtcm@163.com

Yanyan Shang, Master

CONTACT

021-64394141; shqgywk@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label, single-arm trial. While no formal masking is applied, the outcomes assessor will not have access to participant adherence records or follow-up exercise engagement data to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant researcher

Model Details: This is a single-arm trial with 20 participants undergoing a 12-week TCM Daoyin exercise intervention (2 sessions per week), followed by a 12-week observational follow-up period. Primary outcomes (HAMA-14 and HAMD-17 scores) and exploratory biomarkers (inflammatory markers, immune cell subsets, and serum metabolomics) will be assessed at baseline, 12 weeks, and 24 weeks. No control group is included.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 10, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)