Depression Symptoms, Anxiety Symptoms
Conditions
Keywords
Baduanjin, Depression, Anxiety, Randomized controlled trial
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.
Interventions
BEHAVIORALBaduanjin
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.
BEHAVIORALHealth education
Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.
Sponsors
Shanghai Mental Health Center
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessors were blinded to the group allocation of the participants.
Intervention model description
This study is a 16-week, randomized controlled trial. Patients with depression and anxiety symptoms are randomized to either Baduanjin intervention group or health education control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Depression, Anxiety and Stress Scale-21 item | Change from Baseline DASS-21 at 8 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactYing Lu, Master
Backup ContactXiaoting Zhao
Outcome results
None listed