A Pilot Study of Ba Duan Jin for Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- 14-item Hamilton Anxiety Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study was a single-blind controlled trial in which the outcome assessor was blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with depression or anxiety symptom diagnosed by ICD-
- •Subject is male or female, age 18 to
- •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
排除标准
- •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.
结局指标
主要结局
14-item Hamilton Anxiety Rating Scale
时间窗: 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.
17-item Hamilton Depression Rating Scale
时间窗: 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.
次要结局
- Traditional Chinese medicine syndrome grade(16 weeks)
- Depression, Anxiety and Stress Scale-21 item(16 weeks)
- Gut microbiota(16 weeks)
研究者
Lu Ying, MM
Research Associate
Shanghai University of Traditional Chinese Medicine