Baduanjin Training for Depression and Anxiety Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Symptoms; Depression Symptoms
• Intervention / Treatment: Behavioral: Baduanjin; Behavioral: Health education

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Lu, Master; Phone Number: 02154240423; Email: luwing_happy@163.com
• Study Contact Backup: Name: Xiaoting Zhao; Phone Number: 02154240423; Email: zxt7410@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 021
      • Recruiting
      • Shanghai Qigong Research Institute
      • Contact: Jie Li, doctor; Phone Number: 02164383936; Email: lijietcm@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baduanjin intervention group; 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; 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; Behavioral: Health education; Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.
Active Comparator: Health education control group; Participants randomized to the health education control group only receive health education and no additional training program.	Behavioral: Health education; Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change from Baseline HAMA-14 at 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	Change from Baseline respiration depths at 16 weeks

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Shanghai Mental Health Center
• Investigators: Study Chair: Xiaoting Zhao, Shanghai Qigong Research Institute; Principal Investigator: Ying Lu, Shanghai Qigong Research Institute; Study Director: Jie Li, Shanghai University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Randomized controlled trial; Baduanjin
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression
• Other Study ID Numbers: 202040253

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No