Clinical trial NCT06921512: TCM Daoyin for Anxiety/Depression: Psychological Effects and Biological Mechanisms
Official title: TCM Daoyin for Anxiety and Depression Symptoms: Psychological Effects and Biological Mechanisms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Symptom
Depression Symptom
Keywords: Anxiety
Depression
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
First posted: 2025-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 14-item Hamilton Anxiety Rating Scale (HAMA-14)
timeFrame: Change from Baseline at 12 weeks
measure: 17-item Hamilton Depression Rating Scale (HAMD-17)
timeFrame: Change from Baseline at 12 weeks
Secondary outcomes:
measure: 14-item Hamilton Anxiety Rating Scale (HAMA-14)
timeFrame: Change from 12 weeks to 24 weeks
measure: 14-item Hamilton Anxiety Rating Scale (HAMA-14)
timeFrame: Change from Baseline to 24 weeks
measure: 17-item Hamilton Depression Rating Scale (HAMD-17)
timeFrame: Change from 12 weeks to 24 weeks
measure: 17-item Hamilton Depression Rating Scale (HAMD-17)
timeFrame: Change from Baseline to 24 weeks
measure: The Depression, Anxiety, and Stress Scale-21 (DASS-21)
timeFrame: Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from Baseline at 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
measure: Changes in Inflammatory Markers
timeFrame: Change from Baseline at 12 weeks and 24 weeks
measure: Changes in Immune Cell Subsets
timeFrame: Change from Baseline at 12 weeks and 24 weeks
measure: Changes in Serum Metabolomics
timeFrame: Change from Baseline at 12 weeks and 24 weeks
measure: Changes in Gut Microbiota
timeFrame: Change from Baseline at 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Qigong Research Institute
Study officials:
affiliation: Shanghai Qigong Research Institute
name: Ying Lu, Master
role: PRINCIPAL_INVESTIGATOR
References: