TCM Daoyin in the Treatment of Patients With Anxiety State

NCT05932095 | Completed

• 1 other identifier: ZY(2021-2023)- 0105-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety State

Keywords

TCM Daoyin; Anxiety; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 17-item Hamilton Depression Rating Scale

  Change from Baseline HAMD-17 at 12 weeks

• Depression, Anxiety and Stress Scale-21 item

  Baseline

• Depression, Anxiety and Stress Scale-21 item

  6 weeks

• Depression, Anxiety and Stress Scale-21 item

  12 weeks

• Functional magnetic resonance imaging (fMRI)

  Baseline

Study Arms (3)

TCM Daoyin intervention group

EXPERIMENTAL

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.

Behavioral: TCM Daoyin; Behavioral: Health education

Health education control group

ACTIVE COMPARATOR

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

Behavioral: Health education

Healthy Control

NO INTERVENTION

Healthy volunteers for data comparison, receiving no intervention.

Interventions

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.

Also known as: Qigong

TCM Daoyin intervention group

Health education BEHAVIORAL

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

Health education control group; TCM Daoyin intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Shanghai Mental Health Center: collaborator

Study Sites (1)

Shanghai Qigong Research Institute

Shanghai, Shanghai Municipality, 021, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Qigong

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors were blinded to the group allocation of the participants.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant researcher

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: July 6, 2023
• Study Start: June 13, 2023
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)