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NCT Number: NCT04673370

Ba Duan Jin for Depression and Anxiety

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Qigong Research Institute

Shanghai, Shanghai Municipality, 021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Eight-section Brocade

Health Education

Behavioral

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

Primary outcomes

  1. 17-item Hamilton Depression Rating Scale

    Time frame: Change from Baseline HAMD-17 at 16 weeks

    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.

  2. 14-item Hamilton Anxiety Rating Scale

    Time frame: Change from Baseline HAMA-14 at 16 weeks

    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 outcomes

  1. Depression, Anxiety and Stress Scale-21 item

    Time frame: Baseline

    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.

  2. Depression, Anxiety and Stress Scale-21 item

    Time frame: 8 weeks

    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.

  3. Depression, Anxiety and Stress Scale-21 item

    Time frame: 16 weeks

    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.

  4. Gut microbiota

    Time frame: Baseline

    Intestinal microbiome in stool will be measured by 16S sequencing.

  5. Gut microbiota

    Time frame: 16 weeks

    Intestinal microbiome in stool will be measured by 16S sequencing.

  6. Traditional Chinese medicine syndrome grade

    Time frame: Baseline

    Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire.

  7. Traditional Chinese medicine syndrome grade

    Time frame: 16 weeks

    Traditional Chinese medicine(TCM) syndrome will be evaluated by TCM syndrome questionnaire.

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Shanghai Mental Health Center

Registry information

Official study title

A Pilot Study of Ba Duan Jin for Depression and Anxiety

Important dates

Study start
2019
Primary completion
2022
Study completion
2024
First posted
Dec 17, 2020
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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