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

Depression Clinical Trial

Official title:

Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable Chronic Obstructive Pulmonary Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02413840
• Other study ID #: CMU900314
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2015
• Last updated: April 7, 2015
• Start date: December 2014

Study information

• Verified date: April 2015
• Source: Capital Medical University
• Contact: Huimin Gong
• Phone: 8613436379130
• Email: 570866508[@]qq.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial Summary

This study expect to investigate psychological intervention (Baduanjin qigong) in COPD patients combined with anxiety and/or depression.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• COPD
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Baduanjin qigong

Locations

Country	Name	City	State
China	Beijing institute of respiratory diseases	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Huimin Gong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year	No
Secondary	the number of acute exacerbations		one year	No
Secondary	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.	one year	No