Depression, Anxiety
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALBa Duan Jin
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.
BEHAVIORALHealth education
Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.
Sponsors
Shanghai Mental Health Center
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study was a single-blind controlled trial in which the outcome assessor was blinded to group allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 17-item Hamilton Depression Rating Scale | Change from Baseline HAMD-17 at 16 weeks | 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. |
| 14-item Hamilton Anxiety Rating Scale | Change from Baseline HAMA-14 at 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression, Anxiety and Stress Scale-21 item | Baseline | 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. |
| Gut microbiota | Baseline | Intestinal microbiome in stool will be measured by 16S sequencing. |
| Traditional Chinese medicine syndrome grade | Baseline | Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire. |
Countries
China
Outcome results
None listed