Depression SymptomsNCT05589337
Baduanjin Training for Depression and Anxiety Patients
A study testing Baduanjin and Health education in people with Depression Symptoms and Anxiety Symptoms, 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 depression or anxiety are on the rise. The aims of the prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression Symptoms, Anxiety Symptoms
- What is being tested?
- Baduanjin and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with depression or anxiety symptom diagnosed by ICD-10.
- Depression 7≤HAMD-17≤29，anxiety 7≤HAMA-14≤29.
- Subject has a clear mind and the ability to read, to talk and to communicate.
- Subject agrees to participate in this study and sign to the informed consent.
Who cannot join
- Subject with bipolar disorder, psychotic disorder, organic mental disorder and cognitive disorder.
- Subject with alcohol abuse, substance dependence and suicidal behavior in past-year.
- Subject has severe somatic disease.
- Subject is pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Qigong Research Institute
Shanghai, Shanghai Municipality, 021
Jie Li, doctor, 02164383936, lijietcm@163.com
About this study
Official title: Effects of Baduanjin Breathing Training for Depression and Anxiety Patients: a Prospective Randomized Study
In recent years, the number of people with symptoms of depression or anxiety are on the rise. The aims of the prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression or anxiety symptom and changes of lung functions.
Read the detailed description
Depression and anxiety, the two common mental health problems, are prevalent in the world. But there is a lack of sufficient no-drug intervention for relieving these two symptoms. The study focuses on mixed depressive and anxiety disorder, which symptoms are not sufficiently severe, numerous, or persistent to justify a diagnosis of depressive disorder or an anxiety disorder.
Baduanjin is a form of mind-body exercise with a profound philosophical foundation rooted in oriental culture. Previous studies have provided some evidences of beneficial effects on Baduanjin for depression and anxiety. Moreover, the effects and mechanisms of Baduanjin on patients with symptoms of depression and anxiety are yet to be further investigated.
This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 120 participants (60 for Baduanjin intervention group receiving health education plus a Baduanjin breathing training program, and 60 for health education control group only receiving health education).
The aims of the prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression or anxiety symptom and changes of lung function.
- Conditions
- Depression Symptoms, Anxiety Symptoms
- Being tested
- Baduanjin, Health education
- Keywords
- Baduanjin, Depression, Anxiety, Randomized controlled trial
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaduanjinBehavioural
Also called Eight-section Brocade
The Baduanjin training program consisted of two 90-min training classes and at least five 30-min at-home practice sessions per week for 16-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 |
|---|---|---|
| Baduanjin intervention group | Experimental | Participants randomized to Baduanjin intervention group receive health education plus a Baduanjin training program. The Baduanjin training program was a 16-week, instructor-led group training program that offers breathing training as a core skill. Receives: Behavioral: Baduanjin; 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Depression Rating Scale
The 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.
Measured: Change from Baseline HAMD-17 at 16 weeks
14-item Hamilton Anxiety Rating Scale
The 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.
Measured: Change from Baseline HAMA-14 at 16 weeks
Secondary outcomes (9)
Depression, Anxiety and Stress Scale-21 item
The 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: Change from Baseline DASS-21 at 8 weeks
Depression, Anxiety and Stress Scale-21 item
The 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: Change from 8 weeks DASS-21 at 16 weeks
Vital capacity
Vital capacity (VC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Measured: Change from Baseline VC at 16 weeks
Forced vital capacity
Forced vital capacity (FVC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Measured: Change from Baseline FVC at 16 weeks
FVC percentage of predicted normal values
FVC percentage of predicted normal values (FVC%) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Measured: Change from Baseline FVC% at 16 weeks
Forced expiratory volume in one second
Forced expiratory volume in one second (FEV1) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Measured: Change from Baseline FEV1 at 16 weeks
The ratio of FEV1 to FVC
The ratio of FEV1 to FVC (FEV1/FVC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Measured: Change from Baseline FEV1/FVC at 16 weeks
Respiration rates
The respiration rates are recorded by the same equipment (BioHarness, USA) and by the same clinicians following a standard protocol.
Measured: Change from Baseline respiration rates at 16 weeks
Respiration depths
The respiration depths are recorded by the same equipment (BioHarness, USA) and by the same clinicians following a standard protocol.
Measured: Change from Baseline respiration depths at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Jul 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression SymptomsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a 16-week, randomized controlled trial. Patients with depression and anxiety symptoms are randomized to either Baduanjin intervention group or health education control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
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
- Investigators
- Xiaoting Zhao, Study chair, Shanghai Qigong Research InstituteYing Lu, Principal investigator, Shanghai Qigong Research InstituteJie Li, Study director, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589337
- Sponsor's protocol ID
- 202040253
- Status last verified
- Apr 2026
- First submitted
- 17 Oct 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Baduanjin Breathing Training for Depression and Anxiety Patients: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05589337
- Acronym / sponsor ID
- 202040253
- Conditions
- Depression Symptoms, Anxiety Symptoms
- Keywords
- Baduanjin, Depression, Anxiety, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 21 Oct 2022 (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 depression or anxiety are on the rise. The aims of the prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression or anxiety symptom and changes of lung functions.
Detailed description
Depression and anxiety, the two common mental health problems, are prevalent in the world. But there is a lack of sufficient no-drug intervention for relieving these two symptoms. The study focuses on mixed depressive and anxiety disorder, which symptoms are not sufficiently severe, numerous, or persistent to justify a diagnosis of depressive disorder or an anxiety disorder.
Baduanjin is a form of mind-body exercise with a profound philosophical foundation rooted in oriental culture. Previous studies have provided some evidences of beneficial effects on Baduanjin for depression and anxiety. Moreover, the effects and mechanisms of Baduanjin on patients with symptoms of depression and anxiety are yet to be further investigated.
This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 120 participants (60 for Baduanjin intervention group receiving health education plus a Baduanjin breathing training program, and 60 for health education control group only receiving health education).
The aims of the prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression or anxiety symptom and changes of lung function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a 16-week, randomized controlled trial. Patients with depression and anxiety symptoms are randomized to either Baduanjin intervention group or health education control group.
| Arm | Type | Receives |
|---|---|---|
| Baduanjin intervention group | Experimental | Behavioral: Baduanjin, Behavioral: Health educationParticipants randomized to Baduanjin intervention group receive health education plus a Baduanjin training program. The Baduanjin training program was a 16-week, instructor-led group training program that offers breathing training as a core skill. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject with depression or anxiety symptom diagnosed by ICD-10.
- Depression 7≤HAMD-17≤29，anxiety 7≤HAMA-14≤29.
- Subject has a clear mind and the ability to read, to talk and to communicate.
- Subject agrees to participate in this study and sign to the informed consent.
Key exclusion criteria (4 listed)
- Subject with bipolar disorder, psychotic disorder, organic mental disorder and cognitive disorder.
- Subject with alcohol abuse, substance dependence and suicidal behavior in past-year.
- Subject has severe somatic disease.
- Subject is pregnant or lactating women.
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 |
|---|---|---|
| BaduanjinAlso: Eight-section BrocadeThe Baduanjin training program consisted of two 90-min training classes and at least five 30-min at-home practice sessions per week for 16-weeks. All sessions included 10 min of warmup and 10 min of cooldown. | Behavioural | Baduanjin intervention group |
| Health educationHealth education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs. | Behavioural | Baduanjin intervention group, Health education control group |
Primary outcome
17-item Hamilton Depression Rating Scale
Time frame: Change from Baseline HAMD-17 at 16 weeks
The 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.
14-item Hamilton Anxiety Rating Scale
Time frame: Change from Baseline HAMA-14 at 16 weeks
The 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.
9 secondary outcomes
Depression, Anxiety and Stress Scale-21 item
Time frame: Change from Baseline DASS-21 at 8 weeks
Depression, Anxiety and Stress Scale-21 item
Time frame: Change from 8 weeks DASS-21 at 16 weeks
Vital capacity
Time frame: Change from Baseline VC at 16 weeks
Forced vital capacity
Time frame: Change from Baseline FVC at 16 weeks
FVC percentage of predicted normal values
Time frame: Change from Baseline FVC% at 16 weeks
Forced expiratory volume in one second
Time frame: Change from Baseline FEV1 at 16 weeks
The ratio of FEV1 to FVC
Time frame: Change from Baseline FEV1/FVC at 16 weeks
Respiration rates
Time frame: Change from Baseline respiration rates at 16 weeks
Respiration depths
Time frame: Change from Baseline respiration depths at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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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.
Xiaoting Zhao study chair
Shanghai Qigong Research Institute
Ying Lu principal investigator
Shanghai Qigong Research Institute
Jie Li study director
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin and Health education in people with Depression Symptoms and Anxiety Symptoms, 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Lu, Master (02154240423, luwing_happy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17-item Hamilton Depression Rating Scale (time frame: Change from Baseline HAMD-17 at 16 weeks). The study lists 2 primary outcomes in all. 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 29 Apr 2026.