Anxiety StateNCT05932095
TCM Daoyin in the Treatment of Patients With Anxiety State
A study testing TCM Daoyin and Health education in people with Anxiety State, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
In recent years, the number of people with symptoms of anxiety are on the rise. TCM Daoyin is a promising intervention for anxiety. This study is designed to allow researchers to better understand the changes in anxiety symptom, brain activity, and immune function during patients with anxiety states receiving TCM… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety State
- What is being tested?
- TCM Daoyin and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2023to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with a primary mental health complaint of anxiety.
- Anxiety 14≤HAMA-14≤29, Depression 7≤HAMD-17<14.
- Subject has no history of psychotropic medication or has been off medication for more than 6 months.
- Right-handed, aged 18 to 65, male or female.
- Subject has a clear mind and the ability to lead an independent life.
- Subject agrees to participate in fMRI scan and provide signed informed consent.
Who cannot join
- Subject with definite clinical diagnosis of anxiety disorder and depression disorder by ICD-10.
- Subject with bipolar disorder, psychotic disorder (e.g., schizophrenia), organic mental disorder (e.g., Alzheimer's disease).
- Subject with alcohol abuse, substance dependence and suicidal ideation in past-year, or currently taking psychiatric medication, or current serious suicidal attempt.
- Subject with serious current unstable medical illness.
- Subject has claustrophobia, or any contraindication unable or unwilling to participate in fMRI scan.
- Subject is clinically unable to participate in TCM Daoyin training program.
- Subject is pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Qigong Research Institute
Shanghai, Shanghai Municipality, 021
About this study
Official title: TCM Daoyin in the Treatment of Patients With Anxiety State: A Pilot Study
In recent years, the number of people with symptoms of anxiety are on the rise. TCM Daoyin is a promising intervention for anxiety. This study is designed to allow researchers to better understand the changes in anxiety symptom, brain activity, and immune function during patients with anxiety states receiving TCM Daoyin intervention. Thus, the aims of the prospective randomized study are: (1) to examine the effects of TCM Daoyin training on reducing symptoms of anxiety, (2) to measure brain activity by using functional magnetic resonance imaging (fMRI), and (3) to assess Immune function.
Read the detailed description
Anxiety is one of the most common mental health problems in the world. But there is a lack of sufficient no-drug intervention for relieving the anxious symptoms. The study focuses on mild and early anxiety disorder, which symptoms are not sufficiently severe, numerous, or persistent to justify a diagnosis of an anxiety disorder.
TCM Daoyin is a form of mind-body exercise with a profound philosophical foundation rooted in Chinese culture. Previous studies have provided some evidence of beneficial effects on TCM Daoyin for anxiety, such as Baduanjin and Liuzijue. However, the effects and neurophysiology mechanisms of TCM Daoyin on patients with anxiety state are yet to be further investigated.
This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 20 participants (10 for TCM Daoyin intervention group receiving health education plus a TCM Daoyin training program, and 10 for health education control group only receiving health education).
The aims of the prospective randomized study are: (1) to examine the effects of TCM Daoyin training on reducing symptoms of anxiety, (2) to measure brain activity by using functional magnetic resonance imaging (fMRI), and (3) to assess Immune function.
- Conditions
- Anxiety State
- Being tested
- TCM Daoyin, Health education
- Keywords
- TCM Daoyin, Anxiety, Randomized controlled trial
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM DaoyinBehavioural
Also called Qigong
The TCM Daoyin training program consisted of two 90-min training classes and at least five 30-min at-home practice sessions per week for 12-weeks. All sessions included 10 min of warmup and 10 min of cooldown.
Health educationBehavioural
Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.
| Study group | Role | What they receive |
|---|---|---|
| TCM Daoyin intervention group | Experimental | Participants randomized to TCM Daoyin intervention group receive health education plus a TCM Daoyin training program. The TCM Daoyin training program was a 12-week, instructor-led group training program. Receives: Behavioral: TCM Daoyin; Behavioral: Health education |
| Health education control group | Active comparator | Participants randomized to the health education control group only receive health education and no additional training program. Receives: Behavioral: Health education |
| Healthy Control | No intervention | Healthy volunteers for data comparison, receiving no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
14-item Hamilton Anxiety Rating Scale
The 14-item Hamilton Anxiety Rating Scale (HAMA-14) is a clinician-rated assessment (structured interview) of patients' anxious symptoms. Questions focus on anxious symptoms during the past 7 days, and higher cumulative scores indicate more severe anxiety.
The HAMA-14 are rated on 5 grades ranging from 0(no symptom) to 4 (very severe). The total score ranges from 0 to 56. 29 or more on HAMA means severe anxiety disorders, 21 to 28 on HAMA means obvious anxiety disorders, 14 to 20 on HAMA means anxiety disorders, 8 to 13 on HAMA means suspicious anxiety disorders, 7 or less means no anxiety disorders.
Measured: Change from Baseline HAMA-14 at 12 weeks
Secondary outcomes (9)
17-item Hamilton Depression Rating Scale
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated assessment (structured interview) of patients' depressive symptoms. Questions focus on depressive symptoms during the past 7 days, and higher cumulative scores indicate more severe depression.
The HAMD-17 are rated on 5 grades ranging from 0(no symptom) to 4 (very severe). The total score ranges from 0 to 52. 25 or more on HAMD means severe depression disorders, 18 to 24 on HAMD means moderate depression, 13 to 17 on HAMD means mild depression disorders, 8 to 12 on HAMD means suspicious depression disorders, 7 or less means no depression disorders.
Measured: Change from Baseline HAMD-17 at 12 weeks
Depression, Anxiety and Stress Scale-21 item
The Depression, Anxiety and Stress Scale-21 item (DASS-21) is a self-rated assessment of patients' depressive, anxious and stress symptoms. Questions focus on depressive, anxious and stress symptoms during the past 7 days, and higher cumulative scores indicate more severe depression, anxiety and stress. Subscale scores are calculated as the sum of the responses to the seven items from each subscale multiplied by 2. The cutoffs for depression, anxiety, and stress are >9, >7, and >14, respectively.
Measured: Baseline
Depression, Anxiety and Stress Scale-21 item
The Depression, Anxiety and Stress Scale-21 item (DASS-21) is a self-rated assessment of patients' depressive, anxious and stress symptoms. Questions focus on depressive, anxious and stress symptoms during the past 7 days, and higher cumulative scores indicate more severe depression, anxiety and stress. Subscale scores are calculated as the sum of the responses to the seven items from each subscale multiplied by 2. The cutoffs for depression, anxiety, and stress are >9, >7, and >14, respectively.
Measured: 6 weeks
Depression, Anxiety and Stress Scale-21 item
The Depression, Anxiety and Stress Scale-21 item (DASS-21) is a self-rated assessment of patients' depressive, anxious and stress symptoms. Questions focus on depressive, anxious and stress symptoms during the past 7 days, and higher cumulative scores indicate more severe depression, anxiety and stress. Subscale scores are calculated as the sum of the responses to the seven items from each subscale multiplied by 2. The cutoffs for depression, anxiety, and stress are >9, >7, and >14, respectively.
Measured: 12 weeks
Functional magnetic resonance imaging (fMRI)
The fMRI scans will be employed to assess whether engaging in TCM Daoyin training program does or does not alter structural imaging and functional imaging of brain activation. Changes in Blood Oxygen Level Dependent (BOLD) Response is investigated in resting state fMRI and task fMRI.
Measured: Baseline
Functional magnetic resonance imaging (fMRI)
The fMRI scans will be employed to assess whether engaging in TCM Daoyin training program does or does not alter structural imaging and functional imaging of brain activation. Changes in Blood Oxygen Level Dependent (BOLD) Response is investigated in resting state fMRI and task fMRI.
Measured: 12 weeks
Immune function
CD3, CD4, CD8, IL-1β, IL-6 and TNF-α in blood samples will be measured to evaluate immune functions.
Measured: Change from Baseline immune function at 12 weeks
Adverse effects
During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred.
Measured: 6 weeks
Adverse effects
During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start13 Jun 2023
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 12-week, randomized controlled trial with an additional healthy control group. Patients with anxiety state are randomized 1:1 to either the TCM Daoyin intervention group or the health education control group (10 participants each). Additionally, 10 healthy volunteers will be enrolled as a non-randomized healthy control group for data comparison.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Responsible party
- Principal investigator, Lu Ying, MM, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932095
- Sponsor's protocol ID
- ZY(2021-2023)- 0105-07
- Status last verified
- Mar 2025
- First submitted
- 11 Jun 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCM Daoyin in the Treatment of Patients With Anxiety State: A Pilot Study
- ClinicalTrials.gov ID
- NCT05932095
- Acronym / sponsor ID
- ZY(2021-2023)- 0105-07
- Conditions
- Anxiety State
- Keywords
- TCM Daoyin, Anxiety, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, the number of people with symptoms of anxiety are on the rise. TCM Daoyin is a promising intervention for anxiety. This study is designed to allow researchers to better understand the changes in anxiety symptom, brain activity, and immune function during patients with anxiety states receiving TCM Daoyin intervention. Thus, the aims of the prospective randomized study are: (1) to examine the effects of TCM Daoyin training on reducing symptoms of anxiety, (2) to measure brain activity by using functional magnetic resonance imaging (fMRI), and (3) to assess Immune function.
Detailed description
Anxiety is one of the most common mental health problems in the world. But there is a lack of sufficient no-drug intervention for relieving the anxious symptoms. The study focuses on mild and early anxiety disorder, which symptoms are not sufficiently severe, numerous, or persistent to justify a diagnosis of an anxiety disorder.
TCM Daoyin is a form of mind-body exercise with a profound philosophical foundation rooted in Chinese culture. Previous studies have provided some evidence of beneficial effects on TCM Daoyin for anxiety, such as Baduanjin and Liuzijue. However, the effects and neurophysiology mechanisms of TCM Daoyin on patients with anxiety state are yet to be further investigated.
This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 20 participants (10 for TCM Daoyin intervention group receiving health education plus a TCM Daoyin training program, and 10 for health education control group only receiving health education).
The aims of the prospective randomized study are: (1) to examine the effects of TCM Daoyin training on reducing symptoms of anxiety, (2) to measure brain activity by using functional magnetic resonance imaging (fMRI), and (3) to assess Immune function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a 12-week, randomized controlled trial with an additional healthy control group. Patients with anxiety state are randomized 1:1 to either the TCM Daoyin intervention group or the health education control group (10 participants each). Additionally, 10 healthy volunteers will be enrolled as a non-randomized healthy control group for data comparison.
| Arm | Type | Receives |
|---|---|---|
| TCM Daoyin intervention group | Experimental | Behavioral: TCM Daoyin, Behavioral: Health educationParticipants randomized to TCM Daoyin intervention group receive health education plus a TCM Daoyin training program. The TCM Daoyin training program was a 12-week, instructor-led group training program. |
| Health education control group | Active comparator | Behavioral: Health educationParticipants randomized to the health education control group only receive health education and no additional training program. |
| Healthy Control | No intervention | –Healthy volunteers for data comparison, receiving no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject with a primary mental health complaint of anxiety.
- Anxiety 14≤HAMA-14≤29, Depression 7≤HAMD-17<14.
- Subject has no history of psychotropic medication or has been off medication for more than 6 months.
- Right-handed, aged 18 to 65, male or female.
- Subject has a clear mind and the ability to lead an independent life.
Key exclusion criteria (7 listed)
- Subject with definite clinical diagnosis of anxiety disorder and depression disorder by ICD-10.
- Subject with bipolar disorder, psychotic disorder (e.g., schizophrenia), organic mental disorder (e.g., Alzheimer's disease).
- Subject with alcohol abuse, substance dependence and suicidal ideation in past-year, or currently taking psychiatric medication, or current serious suicidal attempt.
- Subject with serious current unstable medical illness.
- Subject has claustrophobia, or any contraindication unable or unwilling to participate in fMRI scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCM DaoyinAlso: QigongThe TCM Daoyin training program consisted of two 90-min training classes and at least five 30-min at-home practice sessions per week for 12-weeks. All sessions included 10 min of warmup and 10 min of cooldown. | Behavioural | TCM Daoyin intervention group |
| Health educationHealth education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs. | Behavioural | Health education control group, TCM Daoyin intervention group |
Primary outcome
14-item Hamilton Anxiety Rating Scale
Time frame: Change from Baseline HAMA-14 at 12 weeks
The 14-item Hamilton Anxiety Rating Scale (HAMA-14) is a clinician-rated assessment (structured interview) of patients' anxious symptoms. Questions focus on anxious symptoms during the past 7 days, and higher cumulative scores indicate more severe anxiety. The HAMA-14 are rated on 5 grades ranging from 0(no symptom) to 4 (very severe). The total score ranges from 0 to 56. 29 or more on HAMA means severe anxiety disorders, 21 to 28 on HAMA means obvious anxiety disorders, 14 to 20 on HAMA means anxiety disorders, 8 to 13 on HAMA means suspicious anxiety disorders, 7 or less means no anxiety disorders.
9 secondary outcomes
17-item Hamilton Depression Rating Scale
Time frame: Change from Baseline HAMD-17 at 12 weeks
Depression, Anxiety and Stress Scale-21 item
Time frame: Baseline
Depression, Anxiety and Stress Scale-21 item
Time frame: 6 weeks
Depression, Anxiety and Stress Scale-21 item
Time frame: 12 weeks
Functional magnetic resonance imaging (fMRI)
Time frame: Baseline
Functional magnetic resonance imaging (fMRI)
Time frame: 12 weeks
Immune function
Time frame: Change from Baseline immune function at 12 weeks
Adverse effects
Time frame: 6 weeks
Adverse effects
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCM Daoyin and Health education in people with Anxiety State, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14-item Hamilton Anxiety Rating Scale (time frame: Change from Baseline HAMA-14 at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.