TCM Daoyin in the Treatment of Patients With Anxiety State

NCT ID: NCT05932095

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-13
• Study Completion Date: 2025-03-20

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.

Conditions

Anxiety State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

TCM Daoyin intervention group

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.

Group Type: EXPERIMENTAL

TCM Daoyin

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Health education control group

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

Group Type: ACTIVE_COMPARATOR

Health education

Intervention Type: BEHAVIORAL

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

Healthy Control

Healthy volunteers for data comparison, receiving no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Health education

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Qigong

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Lu Ying, MM

assistant researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Qigong Research Institute

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ZY(2021-2023)- 0105-07

Identifier Type: -

Identifier Source: org_study_id