Baduanjin Training for Depression and Anxiety Patients

NCT05589337 | Recruiting

• 1 other identifier: 202040253
• Study Type: interventional
• Target: 120
• 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 prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression or anxiety symptom and changes of lung functions.

Conditions

Depression Symptoms; Anxiety Symptoms

Keywords

Baduanjin; Depression; Anxiety; Randomized controlled trial

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 (9)

• Depression, Anxiety and Stress Scale-21 item

  Change from Baseline DASS-21 at 8 weeks

• Depression, Anxiety and Stress Scale-21 item

  Change from 8 weeks DASS-21 at 16 weeks

• Vital capacity

  Change from Baseline VC at 16 weeks

• Forced vital capacity

  Change from Baseline FVC at 16 weeks

• FVC percentage of predicted normal values

  Change from Baseline FVC% at 16 weeks

Study Arms (2)

Baduanjin intervention group

EXPERIMENTAL

Participants randomized to Baduanjin intervention group receive health education plus a Baduanjin training program. The Baduanjin training program was a 16-week, instructor-led group training program that offers breathing training as a core skill.

Behavioral: Baduanjin; 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

Interventions

Baduanjin BEHAVIORAL

The Baduanjin training program consisted of two 90-min training classes and at least five 30-min at-home practice sessions per week for 16-weeks. All sessions included 10 min of warmup and 10 min of cooldown.

Also known as: Eight-section Brocade

Baduanjin intervention group

Health education BEHAVIORAL

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

Baduanjin intervention group; Health education control group

Eligibility Criteria

• Age: 18 Years - 70 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.
• Depression 7≤HAMD-17≤29，anxiety 7≤HAMA-14≤29.
• 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 with bipolar disorder, psychotic disorder, organic mental disorder and cognitive disorder.
• Subject with alcohol abuse, substance dependence and suicidal behavior in past-year.
• Subject has severe somatic disease.
• 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

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Xiaoting Zhao

  Shanghai Qigong Research Institute

  STUDY CHAIR

• Ying Lu

  Shanghai Qigong Research Institute

  PRINCIPAL INVESTIGATOR

• Jie Li

  Shanghai University of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Ying Lu, Master

CONTACT

02154240423; luwing_happy@163.com

Xiaoting Zhao

CONTACT

02154240423; zxt7410@163.com

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: This study is a 16-week, randomized controlled trial. Patients with depression and anxiety symptoms are randomized to either Baduanjin intervention group or health education control group.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 21, 2022
• Study Start: July 1, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CN (1)