Ba Duan Jin for Depression and Anxiety

Not Applicable

Completed

• Conditions: Depression, Anxiety
• Interventions: Behavioral: Ba Duan Jin; Behavioral: Health education

• Registration Number: NCT04673370
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-17
• Primary Completion: 2022-10-31
• Study Completion: 2024-02-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ba Duan Jin Group	Ba Duan Jin	Ba Duan Jin plus health education. Participants take part in 16-week program. The health education is conducted as the Health Education Group. Besides, the participants attended two 90-minute sessions of group-based Ba Duan Jin training per week and practiced at least three 30-minute Ba Duan Jin sessions at home per day.
Health Education Group	Health education	Health education. Participants take part in 16-week program. The health education includes work, rest, diet and other basic programs according to the different conditions of participants.

Primary Outcome Measures

Name	Time	Method
14-item Hamilton Anxiety Rating Scale	Change from Baseline HAMA-14 at 16 weeks	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.
17-item Hamilton Depression Rating Scale	Change from Baseline HAMD-17 at 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Gut microbiota	16 weeks	Intestinal microbiome in stool will be measured by 16S sequencing.
Traditional Chinese medicine syndrome grade	16 weeks	Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire.
Depression, Anxiety and Stress Scale-21 item	16 weeks	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.

Trial Locations

Locations (1)

Shanghai Qigong Research Institute; 🇨🇳 Shanghai, Shanghai, China