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Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable COPD Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Capital Medical University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Huimin Gong, Capital Medical University
ClinicalTrials.gov Identifier:
NCT02413840
First received: February 4, 2015
Last updated: April 7, 2015
Last verified: April 2015
  Purpose
This study expect to investigate psychological intervention (Baduanjin qigong) in COPD patients combined with anxiety and/or depression.

Condition Intervention
COPD
Anxiety
Depression
Behavioral: Baduanjin qigong

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable Chronic Obstructive Pulmonary Disease Patients

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • the number of acute exacerbations [ Time Frame: 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.


Estimated Enrollment: 60
Study Start Date: December 2014
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baduanjin qigong group
Doing exercise of Baduanjin qigong under the guidance of medical staff;psychological counseling at the same time.
Behavioral: Baduanjin qigong
No Intervention: control group
Psychological counseling only.

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.
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02413840

Contacts
Contact: Huimin Gong 8613436379130 570866508@qq.com

Locations
China
Beijing institute of respiratory diseases Recruiting
Beijing, China
Contact: Ting Yang    8613651380809      
Sponsors and Collaborators
Huimin Gong
Investigators
Study Chair: Ting Yang Capital Medical University
  More Information

Responsible Party: Huimin Gong, Resident, Capital Medical University
ClinicalTrials.gov Identifier: NCT02413840     History of Changes
Other Study ID Numbers: CMU900314
Study First Received: February 4, 2015
Last Updated: April 7, 2015

Keywords provided by Capital Medical University:
COPD
Baduanjin qigong
depression
anxiety

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 24, 2017