Baduanjin Training for Depression and Anxiety Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Baduanjin, Health education.
- Who it may be relevant to
- Registry conditions: Depression Symptoms, Anxiety Symptoms. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Baduanjin Breathing Training for Depression and Anxiety Patients: a Prospective Randomized Study
Overview
In recent years, the number of people with symptoms of depression or anxiety are on the rise. The aims of the prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression or anxiety symptom and changes of lung functions.
Detailed description
Depression and anxiety, the two common mental health problems, are prevalent in the world. But there is a lack of sufficient no-drug intervention for relieving these two symptoms. The study focuses on mixed depressive and anxiety disorder, which symptoms are not sufficiently severe, numerous, or persistent to justify a diagnosis of depressive disorder or an anxiety disorder.
Baduanjin is a form of mind-body exercise with a profound philosophical foundation rooted in oriental culture. Previous studies have provided some evidences of beneficial effects on Baduanjin for depression and anxiety. Moreover, the effects and mechanisms of Baduanjin on patients with symptoms of depression and anxiety are yet to be further investigated.
This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 120 participants (60 for Baduanjin intervention group receiving health education plus a Baduanjin breathing training program, and 60 for health education control group only receiving health education).
The aims of the prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression or anxiety symptom and changes of lung function.
Interventions
- Behavioral Baduanjin
The Baduanjin training program consisted of two 90-min training classes and at least five 30-min at-home practice sessions per week for 16-weeks. All sessions included 10 min of warmup and 10 min of cooldown. - Behavioral Health education
Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.
Primary outcome measures
- 17-item Hamilton Depression Rating Scale [Time frame: Change from Baseline HAMD-17 at 16 weeks]
- 14-item Hamilton Anxiety Rating Scale [Time frame: Change from Baseline HAMA-14 at 16 weeks]
Secondary outcome measures (9)
- Depression, Anxiety and Stress Scale-21 item [Time frame: Change from Baseline DASS-21 at 8 weeks]
- Depression, Anxiety and Stress Scale-21 item [Time frame: Change from 8 weeks DASS-21 at 16 weeks]
- Vital capacity [Time frame: Change from Baseline VC at 16 weeks]
- Forced vital capacity [Time frame: Change from Baseline FVC at 16 weeks]
- FVC percentage of predicted normal values [Time frame: Change from Baseline FVC% at 16 weeks]
- Forced expiratory volume in one second [Time frame: Change from Baseline FEV1 at 16 weeks]
- The ratio of FEV1 to FVC [Time frame: Change from Baseline FEV1/FVC at 16 weeks]
- Respiration rates [Time frame: Change from Baseline respiration rates at 16 weeks]
- Respiration depths [Time frame: Change from Baseline respiration depths at 16 weeks]
Eligibility criteria
Inclusion criteria
- Subject with depression or anxiety symptom diagnosed by ICD-10.
- Depression 7≤HAMD-17≤29，anxiety 7≤HAMA-14≤29.
- 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 with bipolar disorder, psychotic disorder, organic mental disorder and cognitive disorder.
- Subject with alcohol abuse, substance dependence and suicidal behavior in past-year.
- Subject has severe somatic disease.
- Subject is pregnant or lactating women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Qigong Research Institute — Shanghai
Identifiers
NCT: NCT05589337 · 202040253