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NCT Number: NCT05932095

TCM Daoyin in the Treatment of Patients With Anxiety State

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.

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Key information

Conditions

Anxiety State Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Qigong Research Institute

Shanghai, Shanghai Municipality, 021, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TCM Daoyin

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.

Other names: Qigong

Health Education

Behavioral

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

Primary outcomes

  1. 14-item Hamilton Anxiety Rating Scale

    Time frame: Change from Baseline HAMA-14 at 12 weeks

    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.

Secondary outcomes

  1. 17-item Hamilton Depression Rating Scale

    Time frame: Change from Baseline HAMD-17 at 12 weeks

    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.

  2. Depression, Anxiety and Stress Scale-21 item

    Time frame: Baseline

    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.

  3. Depression, Anxiety and Stress Scale-21 item

    Time frame: 6 weeks

    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.

  4. Depression, Anxiety and Stress Scale-21 item

    Time frame: 12 weeks

    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.

  5. Functional magnetic resonance imaging (fMRI)

    Time frame: Baseline

    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.

  6. Functional magnetic resonance imaging (fMRI)

    Time frame: 12 weeks

    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.

  7. Immune function

    Time frame: Change from Baseline immune function at 12 weeks

    CD3, CD4, CD8, IL-1β, IL-6 and TNF-α in blood samples will be measured to evaluate immune functions.

  8. Adverse effects

    Time frame: 6 weeks

    During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred.

  9. Adverse effects

    Time frame: 12 weeks

    During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred.

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Shanghai Mental Health Center

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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