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

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:

* Inflammatory markers (e.g., interleukin-10 \[IL-10\], interleukin-6 \[IL-6\], tumor necrosis factor-alpha \[TNF-α\]) via serum ELISA * 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) via flow cytometry * Serum metabolomics using liquid chromatography-mass spectrometry (LC-MS) to identify metabolic changes potentially related to the effects of Daoyin exercise on anxiety and depression * Gut microbiota composition using high-throughput sequencing techniques

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.

• 14-item Hamilton Anxiety Rating Scale (HAMA-14) [Срок оценки: Change from 12 weeks to 24 weeks]
• 14-item Hamilton Anxiety Rating Scale (HAMA-14) [Срок оценки: Change from Baseline to 24 weeks]
• 17-item Hamilton Depression Rating Scale (HAMD-17) [Срок оценки: Change from 12 weeks to 24 weeks]
• 17-item Hamilton Depression Rating Scale (HAMD-17) [Срок оценки: Change from Baseline to 24 weeks]
• The Depression, Anxiety, and Stress Scale-21 (DASS-21) [Срок оценки: Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.]
• Changes in Inflammatory Markers [Срок оценки: Change from Baseline at 12 weeks and 24 weeks]
• Changes in Immune Cell Subsets [Срок оценки: Change from Baseline at 12 weeks and 24 weeks]
• Changes in Serum Metabolomics [Срок оценки: Change from Baseline at 12 weeks and 24 weeks]
• Changes in Gut Microbiota [Срок оценки: Change from Baseline at 12 weeks and 24 weeks]