Clinical trial NCT05589337: Baduanjin Training for Depression and Anxiety Patients
Official title: Effects of Baduanjin Breathing Training for Depression and Anxiety Patients: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression Symptoms
Anxiety Symptoms
Keywords: Baduanjin
Depression
Anxiety
Randomized controlled trial
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
First posted: 2022-10-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
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 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.

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.

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: Change from Baseline DASS-21 at 8 weeks
measure: Depression, Anxiety and Stress Scale-21 item
timeFrame: Change from 8 weeks DASS-21 at 16 weeks
measure: Vital capacity
timeFrame: Change from Baseline VC at 16 weeks
measure: Forced vital capacity
timeFrame: Change from Baseline FVC at 16 weeks
measure: FVC percentage of predicted normal values
timeFrame: Change from Baseline FVC% at 16 weeks
measure: Forced expiratory volume in one second
timeFrame: Change from Baseline FEV1 at 16 weeks
measure: The ratio of FEV1 to FVC
timeFrame: Change from Baseline FEV1/FVC at 16 weeks
measure: Respiration rates
timeFrame: Change from Baseline respiration rates at 16 weeks
measure: Respiration depths
timeFrame: Change from Baseline respiration depths at 16 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Qigong Research Institute
state: Shanghai
Study officials:
affiliation: Shanghai Qigong Research Institute
name: Xiaoting Zhao
role: STUDY_CHAIR
affiliation: Shanghai Qigong Research Institute
name: Ying Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jie Li
role: STUDY_DIRECTOR
References: