Effects of Baduanjin Breathing Training for Depression and Anxiety Patients: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 17-item Hamilton Depression 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 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessors were blinded to the group allocation of the participants.
入排标准
- 年龄范围
- 18 Years 至 70 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-
- •Depression 7≤HAMD-17≤29，anxiety 7≤HAMA-14≤
- •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 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.
结局指标
主要结局
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.
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.
次要结局
- Depression, Anxiety and Stress Scale-21 item(Change from 8 weeks DASS-21 at 16 weeks)
- Vital capacity(Change from Baseline VC at 16 weeks)
- The ratio of FEV1 to FVC(Change from Baseline FEV1/FVC at 16 weeks)
- Respiration depths(Change from Baseline respiration depths at 16 weeks)
- Respiration rates(Change from Baseline respiration rates at 16 weeks)
- Forced vital capacity(Change from Baseline FVC at 16 weeks)
- FVC percentage of predicted normal values(Change from Baseline FVC% at 16 weeks)
- Forced expiratory volume in one second(Change from Baseline FEV1 at 16 weeks)
研究者
Lu Ying, MM
Research Associate
Shanghai University of Traditional Chinese Medicine