TCM Daoyin in the Treatment of Patients With Anxiety State: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 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 anxiety are on the rise. TCM Daoyin is a promising intervention for anxiety. This study is designed to allow researchers to better understand the changes in anxiety symptom, brain activity, and immune function during patients with anxiety states receiving TCM Daoyin intervention. Thus, the aims of the prospective randomized study are: (1) to examine the effects of TCM Daoyin training on reducing symptoms of anxiety, (2) to measure brain activity by using functional magnetic resonance imaging (fMRI), and (3) to assess Immune function.
详细描述
Anxiety is one of the most common mental health problems in the world. But there is a lack of sufficient no-drug intervention for relieving the anxious symptoms. The study focuses on mild and early anxiety disorder, which symptoms are not sufficiently severe, numerous, or persistent to justify a diagnosis of an anxiety disorder.
TCM Daoyin is a form of mind-body exercise with a profound philosophical foundation rooted in Chinese culture. Previous studies have provided some evidence of beneficial effects on TCM Daoyin for anxiety, such as Baduanjin and Liuzijue. However, the effects and neurophysiology mechanisms of TCM Daoyin on patients with anxiety state are yet to be further investigated.
This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 20 participants (10 for TCM Daoyin intervention group receiving health education plus a TCM Daoyin training program, and 10 for health education control group only receiving health education).
The aims of the prospective randomized study are: (1) to examine the effects of TCM Daoyin training on reducing symptoms of anxiety, (2) to measure brain activity by using functional magnetic resonance imaging (fMRI), and (3) to assess Immune function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with a primary mental health complaint of anxiety.
- •Anxiety 14≤HAMA-14≤29, Depression 7≤HAMD-17<
- •Subject has no history of psychotropic medication or has been off medication for more than 6 months.
- •Right-handed, aged 18 to 65, male or female.
- •Subject has a clear mind and the ability to lead an independent life.
- •Subject agrees to participate in fMRI scan and provide signed informed consent.
排除标准
- •Subject with definite clinical diagnosis of anxiety disorder and depression disorder by ICD-
- •Subject with bipolar disorder, psychotic disorder (e.g., schizophrenia), organic mental disorder (e.g., Alzheimer's disease).
- •Subject with alcohol abuse, substance dependence and suicidal ideation in past-year, or currently taking psychiatric medication, or current serious suicidal attempt.
- •Subject with serious current unstable medical illness.
- •Subject has claustrophobia, or any contraindication unable or unwilling to participate in fMRI scan.
- •Subject is clinically unable to participate in TCM Daoyin training program.
- •Subject is pregnant or lactating women.
结局指标
主要结局
14-item Hamilton Anxiety Rating Scale
时间窗: Change from Baseline HAMA-14 at 12 weeks
The 14-item Hamilton Anxiety Rating Scale (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. The HAMA-14 are rated on 5 grades ranging from 0(no symptom) to 4 (very severe). The total score ranges from 0 to 56. 29 or more on HAMA means severe anxiety disorders, 21 to 28 on HAMA means obvious anxiety disorders, 14 to 20 on HAMA means anxiety disorders, 8 to 13 on HAMA means suspicious anxiety disorders, 7 or less means no anxiety disorders.
次要结局
- 17-item Hamilton Depression Rating Scale(Change from Baseline HAMD-17 at 12 weeks)
- Functional magnetic resonance imaging (fMRI)(12 weeks)
- Depression, Anxiety and Stress Scale-21 item(12 weeks)
- Immune function(Change from Baseline immune function at 12 weeks)
- Adverse effects(12 weeks)
研究者
Lu Ying, MM
assistant researcher
Shanghai University of Traditional Chinese Medicine