NCT04673370 - Ba Duan Jin for Depression and Anxiety | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

59

Conditions

Depression, Anxiety

Interventions

Ba Duan JinBEHAVIORAL

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.

Health educationBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Qigong Research Institute

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

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.

Time frame: Baseline

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.

Time frame: 8 weeks

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.