Clinical trial NCT04673370: Ba Duan Jin for Depression and Anxiety
Official title: A Pilot Study of Ba Duan Jin for Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
First posted: 2020-12-17
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 17-item Hamilton Depression Rating Scale
timeFrame: Change from Baseline HAMD-17 at 16 weeks
measure: 14-item Hamilton Anxiety Rating Scale
timeFrame: Change from Baseline HAMA-14 at 16 weeks
Secondary outcomes:
measure: Depression, Anxiety and Stress Scale-21 item
timeFrame: Baseline
measure: Depression, Anxiety and Stress Scale-21 item
timeFrame: 8 weeks
measure: Depression, Anxiety and Stress Scale-21 item
timeFrame: 16 weeks
measure: Gut microbiota
timeFrame: Baseline
measure: Gut microbiota
timeFrame: 16 weeks
measure: Traditional Chinese medicine syndrome grade
timeFrame: Baseline
measure: Traditional Chinese medicine syndrome grade
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Qigong Research Institute
state: Shanghai
Study officials:
References: