TCM Daoyin for Anxiety/Depression: Psychological Effects and Biological Mechanisms
Recruiting · NCT06921512 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Shanghai Qigong Research Institute - Shanghai, China