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Ba Duan Jin for Depression and Anxiety

Primary Purpose

Depression, Anxiety

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ba Duan Jin
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, Anxiety

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Qigong Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ba Duan Jin Group

Health Education Group

Arm Description

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. 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.

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.
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.
Gut microbiota
Intestinal microbiome in stool will be measured by 16S sequencing.
Gut microbiota
Intestinal microbiome in stool will be measured by 16S sequencing.
Traditional Chinese medicine syndrome grade
Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire.
Traditional Chinese medicine syndrome grade
Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire.

Full Information

First Posted
December 8, 2020
Last Updated
July 10, 2023
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT04673370
Brief Title
Ba Duan Jin for Depression and Anxiety
Official Title
A Pilot Study of Ba Duan Jin for Depression and Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (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

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
The study was a single-blind controlled trial in which the outcome assessor was blinded to group allocation.
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ba Duan Jin Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ba Duan Jin
Other Intervention Name(s)
Eight-section Brocade
Intervention Description
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.
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
Baseline
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
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
16 weeks
Title
Gut microbiota
Description
Intestinal microbiome in stool will be measured by 16S sequencing.
Time Frame
Baseline
Title
Gut microbiota
Description
Intestinal microbiome in stool will be measured by 16S sequencing.
Time Frame
16 weeks
Title
Traditional Chinese medicine syndrome grade
Description
Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire.
Time Frame
Baseline
Title
Traditional Chinese medicine syndrome grade
Description
Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Shanghai Qigong Research Institute
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
021
Country
China

12. IPD Sharing Statement

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Ba Duan Jin for Depression and Anxiety

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