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NCT Number: NCT05589337

Baduanjin Training for Depression and Anxiety Patients

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.

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Key information

Conditions

Depression Symptoms Anxiety Disorders Anxiety Symptoms Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Qigong Research Institute

Shanghai, Shanghai Municipality, 021, China

Location status: Recruiting

Location contact

Jie Li, doctor

CONTACT

[email protected]

02164383936

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Baduanjin

Behavioral

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.

Other names: Eight-section Brocade

Health Education

Behavioral

Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Depression, Anxiety and Stress Scale-21 item

    Time frame: Change from Baseline DASS-21 at 8 weeks

    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.

  2. Depression, Anxiety and Stress Scale-21 item

    Time frame: Change from 8 weeks DASS-21 at 16 weeks

    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.

  3. Vital capacity

    Time frame: Change from Baseline VC at 16 weeks

    Vital capacity (VC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.

  4. Forced vital capacity

    Time frame: Change from Baseline FVC at 16 weeks

    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.

  5. FVC percentage of predicted normal values

    Time frame: Change from Baseline FVC% at 16 weeks

    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.

  6. Forced expiratory volume in one second

    Time frame: Change from Baseline FEV1 at 16 weeks

    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.

  7. The ratio of FEV1 to FVC

    Time frame: Change from Baseline FEV1/FVC at 16 weeks

    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.

  8. Respiration rates

    Time frame: Change from Baseline respiration rates at 16 weeks

    The respiration rates are recorded by the same equipment (BioHarness, USA) and by the same clinicians following a standard protocol.

  9. Respiration depths

    Time frame: Change from Baseline respiration depths at 16 weeks

    The respiration depths are recorded by the same equipment (BioHarness, USA) and by the same clinicians following a standard protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoting Zhao

CONTACT

[email protected]

02154240423

Ying Lu, Master

CONTACT

[email protected]

02154240423

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Shanghai Mental Health Center

Registry information

Official study title

Effects of Baduanjin Breathing Training for Depression and Anxiety Patients: a Prospective Randomized Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 21, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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