RecruitingNot ApplicableNCT06921512

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

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


Sponsor

Shanghai University of Traditional Chinese Medicine

Enrollment

20 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a traditional Chinese medicine movement practice called Daoyin — similar to guided breathing and gentle exercises — can help reduce mild anxiety and depression. Researchers also want to understand how it might work at a biological level by looking at blood and stool samples. **You may be eligible if...** - You are between 18 and 65 years old - You have mild-to-moderate anxiety and/or mild depression (based on standard rating scales) - You have not taken psychiatric medications, or stopped them at least 6 months ago - You have clear thinking and can communicate normally - You are willing to provide blood and stool samples **You may NOT be eligible if...** - You have a formally diagnosed anxiety disorder or major depressive disorder - You have bipolar disorder or psychotic symptoms - You are currently taking psychiatric medications - You have serious physical health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALTCM 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.


Locations(1)

Shanghai Qigong Research Institute

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06921512


Related Trials