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Baduanjin Training for Depression and Anxiety Patients

Primary Purpose

Depression Symptoms, Anxiety Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baduanjin
Health education
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression Symptoms focused on measuring Baduanjin, Depression, Anxiety, Randomized controlled trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 lactating or breast-feeding women.

Sites / Locations

  • Shanghai Qigong Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Baduanjin intervention group

Health education control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Vital capacity
Vital capacity (VC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Forced vital capacity
Forced vital capacity (FVC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
FVC percentage of predicted normal values
FVC percentage of predicted normal values (FVC%) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Forced expiratory volume in one second
Forced expiratory volume in one second (FEV1) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
The ratio of FEV1 to FVC
The ratio of FEV1 to FVC (FEV1/FVC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Respiration rates
The respiration rates are recorded by the same equipment (BioHarness, USA) and by the same clinicians following a standard protocol.
Respiration depths
The respiration depths are recorded by the same equipment (BioHarness, USA) and by the same clinicians following a standard protocol.

Full Information

First Posted
October 17, 2022
Last Updated
June 11, 2023
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05589337
Brief Title
Baduanjin Training for Depression and Anxiety Patients
Official Title
Effects of Baduanjin Breathing Training for Depression and Anxiety Patients: a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Symptoms, Anxiety Symptoms
Keywords
Baduanjin, Depression, Anxiety, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
The outcome assessors were blinded to the group allocation of the participants.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baduanjin intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Health education control group
Arm Type
Active Comparator
Arm Description
Participants randomized to the health education control group only receive health education and no additional training program.
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin
Other Intervention Name(s)
Eight-section Brocade
Intervention Description
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
Intervention Name(s)
Health education
Intervention Description
Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.
Primary Outcome Measure Information:
Title
17-item Hamilton Depression Rating Scale
Description
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.
Time Frame
Change from Baseline HAMD-17 at 16 weeks
Title
14-item Hamilton Anxiety Rating Scale
Description
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.
Time Frame
Change from Baseline HAMA-14 at 16 weeks
Secondary Outcome Measure Information:
Title
Depression, Anxiety and Stress Scale-21 item
Description
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.
Time Frame
Change from Baseline DASS-21 at 8 weeks
Title
Depression, Anxiety and Stress Scale-21 item
Description
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.
Time Frame
Change from 8 weeks DASS-21 at 16 weeks
Title
Vital capacity
Description
Vital capacity (VC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Time Frame
Change from Baseline VC at 16 weeks
Title
Forced vital capacity
Description
Forced vital capacity (FVC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Time Frame
Change from Baseline FVC at 16 weeks
Title
FVC percentage of predicted normal values
Description
FVC percentage of predicted normal values (FVC%) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Time Frame
Change from Baseline FVC% at 16 weeks
Title
Forced expiratory volume in one second
Description
Forced expiratory volume in one second (FEV1) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Time Frame
Change from Baseline FEV1 at 16 weeks
Title
The ratio of FEV1 to FVC
Description
The ratio of FEV1 to FVC (FEV1/FVC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Time Frame
Change from Baseline FEV1/FVC at 16 weeks
Title
Respiration rates
Description
The respiration rates are recorded by the same equipment (BioHarness, USA) and by the same clinicians following a standard protocol.
Time Frame
Change from Baseline respiration rates at 16 weeks
Title
Respiration depths
Description
The respiration depths are recorded by the same equipment (BioHarness, USA) and by the same clinicians following a standard protocol.
Time Frame
Change from Baseline respiration depths at 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Lu, Master
Phone
02154240423
Email
luwing_happy@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoting Zhao
Phone
02154240423
Email
zxt7410@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoting Zhao
Organizational Affiliation
Shanghai Qigong Research Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ying Lu
Organizational Affiliation
Shanghai Qigong Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jie Li
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Qigong Research Institute
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Li, doctor
Phone
02164383936
Email
lijietcm@163.com

12. IPD Sharing Statement

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Baduanjin Training for Depression and Anxiety Patients

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