Baduanjin Training for Depression and Anxiety Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression Symptoms, Anxiety Symptoms

Intervention / Treatment
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* Behavioral: Baduanjin
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Baduanjin, Depression, Anxiety, Randomized controlled trial