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 Locations

  • China
      • 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.
Behavioral: Baduanjin qigong
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

Huimin Gong

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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