Clinical trial NCT05932095: TCM Daoyin in the Treatment of Patients With Anxiety State
Official title: TCM Daoyin in the Treatment of Patients With Anxiety State: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Keywords: TCM Daoyin
Anxiety
Randomized controlled trial
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
First posted: 2023-07-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 12-week, randomized controlled trial with an additional healthy control group. Patients with anxiety state are randomized 1:1 to either the TCM Daoyin intervention group or the health education control group (10 participants each). Additionally, 10 healthy volunteers will be enrolled as a non-randomized healthy control group for data comparison.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: 14-item Hamilton Anxiety Rating Scale
timeFrame: Change from Baseline HAMA-14 at 12 weeks
Secondary outcomes:
measure: 17-item Hamilton Depression Rating Scale
timeFrame: Change from Baseline HAMD-17 at 12 weeks
measure: Depression, Anxiety and Stress Scale-21 item
timeFrame: Baseline
measure: Depression, Anxiety and Stress Scale-21 item
timeFrame: 6 weeks
measure: Depression, Anxiety and Stress Scale-21 item
timeFrame: 12 weeks
measure: Functional magnetic resonance imaging (fMRI)
timeFrame: Baseline
measure: Functional magnetic resonance imaging (fMRI)
timeFrame: 12 weeks
measure: Immune function
timeFrame: Change from Baseline immune function at 12 weeks
measure: Adverse effects
timeFrame: 6 weeks
measure: Adverse effects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Qigong Research Institute
state: Shanghai
Study officials:
References: