- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413840
Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable COPD Patients
April 7, 2015 updated by: Huimin Gong
Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable Chronic Obstructive Pulmonary Disease Patients
This study expect to investigate psychological intervention (Baduanjin qigong) in COPD patients combined with anxiety and/or depression.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huimin Gong
- Phone Number: 8613436379130
- Email: 570866508@qq.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Beijing institute of respiratory diseases
-
Contact:
- Ting Yang
- Phone Number: 8613651380809
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Baduanjin qigong group
Doing exercise of Baduanjin qigong under the guidance of medical staff;psychological counseling at the same time.
|
|
No Intervention: control group
Psychological counseling only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stage of anxiety and depression ((Hospital Anxiety and Depression Scale)
Time Frame: one year
|
use psychological questionnaires(Hospital Anxiety and Depression Scale,etc)to evaluate the stage of anxiety and/or depression
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number of acute exacerbations
Time Frame: one year
|
one year
|
|
lung function (pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected)
Time Frame: one year
|
use pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ting Yang, Capital Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
May 1, 2015
Study Registration Dates
First Submitted
February 4, 2015
First Submitted That Met QC Criteria
April 7, 2015
First Posted (Estimate)
April 10, 2015
Study Record Updates
Last Update Posted (Estimate)
April 10, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMU900314
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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