An interventional study of Baduanjin and Health education in Depression Symptoms and Anxiety Symptoms, sponsored by Shanghai University of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Shanghai University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 120 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 102 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Baduanjin · Behavioral: Health education
Participants randomized to the health education control group only receive health education and no additional training program.
Behavioral: Health education
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.
Also known as: Eight-section Brocade
Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.
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.
Time frame: 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.
Time frame: Change from Baseline HAMA-14 at 16 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline respiration depths at 16 weeks
Started Jul 2021 (actual). Primary completion is estimated for Dec 2026, 65 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 65 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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