Baduanjin Training for Depression and Anxiety Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai University of Traditional Chinese Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Baduanjin
BehavioralThe 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.
Health education
BehavioralHealth education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Baduanjin intervention groupExperimental treatment 2 interventions
Group B: Health education control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
17-item Hamilton Depression Rating Scale
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.
Time frame
Change from Baseline HAMD-17 at 16 weeks2
14-item Hamilton Anxiety Rating Scale
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.
Time frame
Change from Baseline HAMA-14 at 16 weeksSecondary outcomes
1
Depression, Anxiety and Stress Scale-21 item
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.
Time frame
Change from Baseline DASS-21 at 8 weeks2
Depression, Anxiety and Stress Scale-21 item
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.
Time frame
Change from 8 weeks DASS-21 at 16 weeks3
Vital capacity
Vital capacity (VC) is tested by spirometry in the same machine (MINATO AS-507, Japan) and by the same clinicians following a standard protocol.
Time frame
Change from Baseline VC at 16 weeks4
Forced vital capacity
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.
Time frame
Change from Baseline FVC at 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai University of Traditional Chinese Medicine
Lead sponsor
Shanghai Mental Health Center
Collaborator
Source ClinicalTrials.gov