Ba Duan Jin for Depression and Anxiety

NCT04673370 | Completed

• 1 other identifier: ZY(2018-2020)-CCCX-2007
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Depression, Anxiety and Stress Scale-21 item

  Baseline

• Depression, Anxiety and Stress Scale-21 item

  8 weeks

• Depression, Anxiety and Stress Scale-21 item

  16 weeks

• Gut microbiota

  Baseline

• Gut microbiota

  16 weeks

Study Arms (2)

Ba Duan Jin Group

EXPERIMENTAL

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.

Behavioral: Ba Duan Jin

Health Education Group

ACTIVE COMPARATOR

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.

Behavioral: Health education

Interventions

Ba Duan Jin BEHAVIORAL

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.

Also known as: Eight-section Brocade

Ba Duan Jin Group

Health education BEHAVIORAL

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

Health Education Group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

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

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study was a single-blind controlled trial in which the outcome assessor was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: A total of 60 patients were divided into a treatment group and a control group, with 30 cases in each group. The control group received health education，and the treatment group was treated with Ba Duan Jin plus health education program.

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 17, 2020
• Study Start: April 10, 2019
• Primary Completion: October 31, 2022
• Study Completion: February 4, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CN (1)