TCM Daoyin in the Treatment of Patients With Anxiety State

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
TCM Daoyin in the Treatment of Patients With Anxiety State: A Pilot Study

Conditions
-----------------
Anxiety State

Intervention / Treatment
-----------------
* Behavioral: TCM Daoyin
* Behavioral: Health education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with a primary mental health complaint of anxiety. Anxiety 14≤HAMA-14≤29, Depression 7≤HAMD-17<14. 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. Exclusion Criteria: Subject with definite clinical diagnosis of anxiety disorder and depression disorder by ICD-10. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a 12-week, randomized controlled trial. Patients with anxiety state are randomized to either TCM Daoyin intervention group or health education control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM Daoyin intervention group<br>Participants randomized to TCM Daoyin intervention group receive health education plus a TCM Daoyin training program. The TCM Daoyin training program was a 12-week, instructor-led group training program. | Behavioral: TCM Daoyin<br>* The TCM Daoyin training program consisted of two 90-min training classes and at least five 30-min at-home practice sessions per week for 12-weeks. All sessions included 10 min of warmup and 10 min of cooldown.<br>* Other names: Qigong;Behavioral: Health education<br>* Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.<br>|
| Active Comparator: Health education control group<br>Participants randomized to the health education control group only receive health education and no additional training program. | Behavioral: Health education<br>* Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 14-item Hamilton Anxiety Rating Scale | 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. | Change from Baseline HAMA-14 at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 17-item Hamilton Depression Rating Scale | The 17-item Hamilton Depression Rating Scale (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. The HAMD-17 are rated on 5 grades ranging from 0(no symptom) to 4 (very severe). The total score ranges from 0 to 52. 25 or more on HAMD means severe depression disorders, 18 to 24 on HAMD means moderate depression, 13 to 17 on HAMD means mild depression disorders, 8 to 12 on HAMD means suspicious depression disorders, 7 or less means no depression disorders. | Change from Baseline HAMD-17 at 12 weeks | 
| Depression, Anxiety and Stress Scale-21 item | The Depression, Anxiety and Stress Scale-21 item (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. | Baseline | 
| Depression, Anxiety and Stress Scale-21 item | The Depression, Anxiety and Stress Scale-21 item (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. | 6 weeks | 
| Depression, Anxiety and Stress Scale-21 item | The Depression, Anxiety and Stress Scale-21 item (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. | 12 weeks | 
| Functional magnetic resonance imaging (fMRI) | The fMRI scans will be employed to assess whether engaging in TCM Daoyin training program does or does not alter structural imaging and functional imaging of brain activation. Changes in Blood Oxygen Level Dependent (BOLD) Response is investigated in resting state fMRI and task fMRI. | Baseline | 
| Functional magnetic resonance imaging (fMRI) | The fMRI scans will be employed to assess whether engaging in TCM Daoyin training program does or does not alter structural imaging and functional imaging of brain activation. Changes in Blood Oxygen Level Dependent (BOLD) Response is investigated in resting state fMRI and task fMRI. | 12 weeks | 
| Immune function | CD3, CD4, CD8, IL-1β, IL-6 and TNF-α in blood samples will be measured to evaluate immune functions. | Change from Baseline immune function at 12 weeks | 
| Adverse effects | During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred. | 6 weeks | 
| Adverse effects | During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TCM Daoyin, Anxiety, Randomized controlled trial