Ba Duan Jin for Depression and Anxiety

Depression, Anxiety Clinical Trial

Official title:

A Pilot Study of Ba Duan Jin for Depression and Anxiety

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04673370
• Other study ID #: ZY(2018-2020)-CCCX-2007
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In recent years, the number of people with symptoms of depression or anxiety are on the rise. The aims of the present study is to examine the effects of Ba Duan Jin on reducing symptoms of depression or anxiety.

Description:

There is growing interest in mind-body therapy that could potentially improve patients' psychological health. Ba Duan Jin, a traditional Chinese health-preserving technique, combines techniques regulating body, breath and spirit. The effects of Ba Duan Jin on patients with symptoms of depression and anxiety are yet to be further investigated. The present pilot clinical study aims to apply Ba Duan Jin to patients with symptoms of depression and anxiety, and to evaluate the psychological effects. Participants allocated to the Health Education Group take part in the 16-week health education including work, rest, diet and other basic programs according to the different conditions of participants. Participants allocated to the Ba Duan Jin Group take part in the 16-week Ba Duan Jin plus health education program. The study plans to enroll 60 participants (30 for Ba Duan Jin plus health education program, and 30 for health education program), expecting that Ba Duan Jin has a better effect on improving psychological condition.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Subject with depression or anxiety symptom diagnosed by ICD-10.
• Subject is male or female, age 18 to 75.
• Subject has a clear mind and the ability to read, to talk and to communicate.
• Subject agrees to participate in this study and sign to the informed consent

Exclusion Criteria:

• Subject has severe somatic disease.
• Subject has history of organic mental disorder, epilepsy, schizophrenia.
• Subject takes any medication of food having effect on gut microbiota within 1 month of screening.
• Subject has history of alcohol abuse.
• Subject is pregnant, lactating or breast-feeding women.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder

Intervention

Behavioral:
• Ba Duan Jin
Ba Duan Jin, a traditional Chinese health-preserving technique, combines techniques regulating body, breath and spirit. According to traditional Chinese theory, every movement of Ba Duan Jin has unique effect to different Zang-fu organs.
• Health education
Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.

Locations

Country	Name	City	State
China	Shanghai Qigong Research Institute	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17-item Hamilton Depression Rating Scale	The 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.	Change from Baseline HAMD-17 at 16 weeks
Primary	14-item Hamilton Anxiety Rating Scale	The 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.	Change from Baseline HAMA-14 at 16 weeks
Secondary	Depression, Anxiety and Stress Scale-21 item	The 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.	Baseline
Secondary	Depression, Anxiety and Stress Scale-21 item	The 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.	8 weeks
Secondary	Depression, Anxiety and Stress Scale-21 item	The 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.	16 weeks
Secondary	Gut microbiota	Intestinal microbiome in stool will be measured by 16S sequencing.	Baseline
Secondary	Gut microbiota	Intestinal microbiome in stool will be measured by 16S sequencing.	16 weeks
Secondary	Traditional Chinese medicine syndrome grade	Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire.	Baseline
Secondary	Traditional Chinese medicine syndrome grade	Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire.	16 weeks