Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable COPD Patients
Primary Purpose
COPD, Anxiety, Depression
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baduanjin qigong
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, Baduanjin qigong, depression, anxiety
Eligibility Criteria
Inclusion Criteria:
- Diagnosed of COPD
- In stable phase
- FEV1%predicted <80.
Exclusion Criteria:
- Cancer
- Severe cerebrovascular disease
- Severe arrhythmia,cardiac insufficiency
- Alzheimer's disease
- Mental illness
- Severe liver disfunction
- Severe renal disfunction
- Physical activity disable.
Sites / Locations
- Beijing institute of respiratory diseasesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Baduanjin qigong group
control group
Arm Description
Doing exercise of Baduanjin qigong under the guidance of medical staff;psychological counseling at the same time.
Psychological counseling only.
Outcomes
Primary Outcome Measures
stage of anxiety and depression ((Hospital Anxiety and Depression Scale)
use psychological questionnaires(Hospital Anxiety and Depression Scale,etc)to evaluate the stage of anxiety and/or depression
Secondary Outcome Measures
the number of acute exacerbations
lung function (pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected)
use pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02413840
Brief Title
Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable COPD Patients
Official Title
Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Huimin Gong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study expect to investigate psychological intervention (Baduanjin qigong) in COPD patients combined with anxiety and/or depression.
Detailed Description
Anxiety and depression is one of the most common complications of COPD patients.This research use psychological questionnaires to evaluate the stage of COPD patients with anxiety and/or depression(asymptomatic, subclinical,clinical). The subclinical type will divided into the treatment group of Baduanjin qigong,and the control group. Two groups are all receive the same psychological counseling, the treatment group also receive further treatment of Baduanjin qigong under the guidance of medical staff. The treatment along for 1 year. Two groups were followed up for 2 years, dynamically observe the stage of anxiety and depression,the number of exacerbations,lung function,etc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Anxiety, Depression
Keywords
COPD, Baduanjin qigong, depression, anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baduanjin qigong group
Arm Type
Experimental
Arm Description
Doing exercise of Baduanjin qigong under the guidance of medical staff;psychological counseling at the same time.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Psychological counseling only.
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin qigong
Primary Outcome Measure Information:
Title
stage of anxiety and depression ((Hospital Anxiety and Depression Scale)
Description
use psychological questionnaires(Hospital Anxiety and Depression Scale,etc)to evaluate the stage of anxiety and/or depression
Time Frame
one year
Secondary Outcome Measure Information:
Title
the number of acute exacerbations
Time Frame
one year
Title
lung function (pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected)
Description
use pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed of COPD
In stable phase
FEV1%predicted <80.
Exclusion Criteria:
Cancer
Severe cerebrovascular disease
Severe arrhythmia,cardiac insufficiency
Alzheimer's disease
Mental illness
Severe liver disfunction
Severe renal disfunction
Physical activity disable.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huimin Gong
Phone
8613436379130
Email
570866508@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Yang
Organizational Affiliation
Capital Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing institute of respiratory diseases
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Yang
Phone
8613651380809
12. IPD Sharing Statement
Learn more about this trial
Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable COPD Patients
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