Baduanjin Training for Depression and Anxiety Patients

NCT ID: NCT05589337

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2026-07-30

Brief Summary

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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.

Detailed Description

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Depression and anxiety, the two common mental health problems, are prevalent in the world. But there is a lack of sufficient no-drug intervention for relieving these two symptoms. The study focuses on mixed depressive and anxiety disorder, which symptoms are not sufficiently severe, numerous, or persistent to justify a diagnosis of depressive disorder or an anxiety disorder.

Baduanjin is a form of mind-body exercise with a profound philosophical foundation rooted in oriental culture. Previous studies have provided some evidences of beneficial effects on Baduanjin for depression and anxiety. Moreover, the effects and mechanisms of Baduanjin on patients with symptoms of depression and anxiety are yet to be further investigated.

This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 120 participants (60 for Baduanjin intervention group receiving health education plus a Baduanjin breathing training program, and 60 for health education control group only receiving health education).

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 function.

Conditions

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Depression Symptoms Anxiety Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessors were blinded to the group allocation of the participants.

Study Groups

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Baduanjin intervention group

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.

Group Type EXPERIMENTAL

Baduanjin

Intervention Type 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.

Health education

Intervention Type BEHAVIORAL

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

Health education control group

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

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type BEHAVIORAL

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

Interventions

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Baduanjin

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.

Intervention Type BEHAVIORAL

Health education

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Eight-section Brocade

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Lu Ying, MM

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoting Zhao

Role: STUDY_CHAIR

Shanghai Qigong Research Institute

Ying Lu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Qigong Research Institute

Jie Li

Role: STUDY_DIRECTOR

Shanghai University of Traditional Chinese Medicine

Locations

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Shanghai Qigong Research Institute

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Lu, Master

Role: CONTACT

02154240423

Xiaoting Zhao

Role: CONTACT

02154240423

Facility Contacts

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Jie Li, doctor

Role: primary

02164383936

Other Identifiers

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202040253

Identifier Type: -

Identifier Source: org_study_id

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