TCM Daoyin in the Treatment of Patients With Anxiety State

Anxiety State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932095
• Other study ID #: ZY(2021-2023)- 0105-07
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Ying Lu, Master
• Phone: 02154240423
• Email: luwing_happy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State

Intervention

Behavioral:
• TCM Daoyin
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.
• Health education
Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.

Locations

Country	Name	City	State
China	Shanghai Qigong Research Institute	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Immune function	CD3, CD4, CD8, IL-1ß, IL-6 and TNF-a in blood samples will be measured to evaluate immune functions.	Change from Baseline immune function at 12 weeks
Secondary	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
Secondary	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