TCM Daoyin for Anxiety/Depression: Psychological Effects and Biological Mechanisms
TCM Daoyin for Anxiety and Depression Symptoms: Psychological Effects and Biological Mechanisms
Shanghai University of Traditional Chinese Medicine
20 participants
Apr 10, 2025
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
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Interventions
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)
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NCT06921512