Ba Duan Jin for Depression and Anxiety

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 present study is to examine the effects of Ba Duan Jin on reducing symptoms of depression or anxiety.

Detailed Description
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There is growing interest in mind-body therapy that could potentially improve patients' psychological health. Ba Duan Jin, a traditional Chinese health-preserving technique, combines techniques regulating body, breath and spirit. The effects of Ba Duan Jin on patients with symptoms of depression and anxiety are yet to be further investigated. The present pilot clinical study aims to apply Ba Duan Jin to patients with symptoms of depression and anxiety, and to evaluate the psychological effects. Participants allocated to the Health Education Group take part in the 16-week health education including work, rest, diet and other basic programs according to the different conditions of participants. Participants allocated to the Ba Duan Jin Group take part in the 16-week Ba Duan Jin plus health education program. The study plans to enroll 60 participants (30 for Ba Duan Jin plus health education program, and 30 for health education program), expecting that Ba Duan Jin has a better effect on improving psychological condition.

Official Title
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A Pilot Study of Ba Duan Jin for Depression and Anxiety

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Ba Duan Jin
* 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. Subject is male or female, age 18 to 75. 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 has severe somatic disease. Subject has history of organic mental disorder, epilepsy, schizophrenia. Subject takes any medication of food having effect on gut microbiota within 1 month of screening. Subject has history of alcohol abuse. Subject is pregnant, lactating or breast-feeding women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 60 patients were divided into a treatment group and a control group, with 30 cases in each group. The control group received health education，and the treatment group was treated with Ba Duan Jin plus health education program.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ba Duan Jin Group<br>Ba Duan Jin plus health education. Participants take part in 16-week program. The health education is conducted as the Health Education Group. Besides, the participants attended two 90-minute sessions of group-based Ba Duan Jin training per week and practiced at least three 30-minute Ba Duan Jin sessions at home per day. | Behavioral: Ba Duan Jin<br>* Ba Duan Jin, a traditional Chinese health-preserving technique, combines techniques regulating body, breath and spirit. According to traditional Chinese theory, every movement of Ba Duan Jin has unique effect to different Zang-fu organs.<br>* Other names: Eight-section Brocade;|
| Active Comparator: Health Education Group<br>Health education. Participants take part in 16-week program. The health education includes work, rest, diet and other basic programs according to the different conditions of participants. | 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. | Baseline | 
| 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. | 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. | 16 weeks | 
| Gut microbiota | Intestinal microbiome in stool will be measured by 16S sequencing. | Baseline | 
| Gut microbiota | Intestinal microbiome in stool will be measured by 16S sequencing. | 16 weeks | 
| Traditional Chinese medicine syndrome grade | Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire. | Baseline | 
| Traditional Chinese medicine syndrome grade | Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire. | 16 weeks |