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| Name | Class |
|---|---|
| Shanghai Mental Health Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ba Duan Jin Group | Experimental | 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. |
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| Health Education Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ba Duan Jin | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Qigong Research Institute | Shanghai | Shanghai Municipality | 021 | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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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.
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The study was a single-blind controlled trial in which the outcome assessor was blinded to group allocation.
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| Health education | Behavioral | Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs. |
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| 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 |