A Pilot Study of Ba Duan Jin for Depression and Anxiety
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- 14-item Hamilton Anxiety Rating Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The study was a single-blind controlled trial in which the outcome assessor was blinded to group allocation.
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject with depression or anxiety symptom diagnosed by ICD-
- •Subject is male or female, age 18 to
- •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.
Arms & Interventions
Ba Duan Jin Group
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.
Intervention: Ba Duan Jin (Behavioral)
Health Education Group
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: Health education (Behavioral)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Traditional Chinese medicine syndrome grade(16 weeks)
- Depression, Anxiety and Stress Scale-21 item(16 weeks)
- Gut microbiota(16 weeks)
- Depression, Anxiety and Stress Scale-21 item(Baseline)
- Depression, Anxiety and Stress Scale-21 item(8 weeks)
- Gut microbiota(Baseline)
- Traditional Chinese medicine syndrome grade(Baseline)
Investigators
Lu Ying, MM
Research Associate
Shanghai University of Traditional Chinese Medicine