TCM Daoyin in the Treatment of Patients With Anxiety State

Shanghai University of Traditional Chinese Medicine

Status: Completed

Conditions: Anxiety State

Treatments: Behavioral: Health education; Behavioral: TCM Daoyin

Study type: Interventional

Funder types: Other

Identifiers

NCT05932095

ZY(2021-2023)- 0105-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

TCM Daoyin intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: TCM Daoyin

Behavioral: Health education

Health education control group

Active Comparator group

Description:

Participants randomized to the health education control group only receive health education and no additional training program.

Treatment:

Behavioral: Health education

Healthy Control

No Intervention group

Description:

Healthy volunteers for data comparison, receiving no intervention.