Baduanjin Training for Depression and Anxiety Patients
- Conditions
- Anxiety SymptomsDepression Symptoms
- Interventions
- Behavioral: BaduanjinBehavioral: Health education
- Registration Number
- NCT05589337
- Lead Sponsor
- Shanghai University of Traditional Chinese Medicine
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Baduanjin intervention group Baduanjin Participants randomized to Baduanjin intervention group receive health education plus a Baduanjin training program. The Baduanjin training program was a 16-week, instructor-led group training program that offers breathing training as a core skill. Baduanjin intervention group Health education Participants randomized to Baduanjin intervention group receive health education plus a Baduanjin training program. The Baduanjin training program was a 16-week, instructor-led group training program that offers breathing training as a core skill. Health education control group Health education Participants randomized to the health education control group only receive health education and no additional training program.
- Primary Outcome Measures
Name Time Method 17-item Hamilton Depression Rating Scale 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.
14-item Hamilton Anxiety Rating Scale 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 Outcome Measures
Name Time Method Depression, Anxiety and Stress Scale-21 item Change from 8 weeks DASS-21 at 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.
Vital capacity Change from Baseline VC at 16 weeks Vital capacity (VC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
The ratio of FEV1 to FVC Change from Baseline FEV1/FVC at 16 weeks The ratio of FEV1 to FVC (FEV1/FVC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Respiration depths Change from Baseline respiration depths at 16 weeks The respiration depths are recorded by the same equipment (BioHarness, USA) and by the same clinicians following a standard protocol.
Respiration rates Change from Baseline respiration rates at 16 weeks The respiration rates are recorded by the same equipment (BioHarness, USA) and by the same clinicians following a standard protocol.
Forced vital capacity Change from Baseline FVC at 16 weeks Forced vital capacity (FVC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
FVC percentage of predicted normal values Change from Baseline FVC% at 16 weeks FVC percentage of predicted normal values (FVC%) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Forced expiratory volume in one second Change from Baseline FEV1 at 16 weeks Forced expiratory volume in one second (FEV1) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Trial Locations
- Locations (1)
Shanghai Qigong Research Institute
🇨🇳Shanghai, Shanghai, China