Baduanjin Training for Depression and Anxiety Patients

Anxiety Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05589337
• Other study ID #: 202040253
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Ying Lu, Master
• Phone: 02154240423
• Email: luwing_happy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 or anxiety symptom and changes of lung functions.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Symptoms
• Depression
• Depression Symptoms
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Qigong Research Institute	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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