Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression

Depression Clinical Trial

Official title:

Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03187249
• Other study ID #: 2016YFC1304404B
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2017
• Last updated: June 13, 2017
• Start date: June 15, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2017
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Jiangna Han, MD
• Phone: 13520053104
• Email: 13520053104[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anxiety and depression have negative effect on outcomes of chronic obstructive pulmonary disease (COPD). Intervention strategy including behavioral-cognitive therapy and pulmonary rehabilitation are promising in improving life quality, disease symptom and outcomes. But there's not standard algorithm in China so far. The study aims to compare the effectiveness of these interventions and develop an intervention algorithm of anxiety and depression in COPD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Stable COPD patients with mild or moderate anxiety and depression

Exclusion Criteria:

• Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months

• Patients with tumor history during past 5 years

• Patients with COPD exacerbations during past 4 weeks

• Participants in clinical trials

• Patients in pregnancy or breastfeeding

• Patients unable to complete questionaire independently

• Patients older than 80 years old

• Patients receiving long-term domiciliary oxygen therapy

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• COPD
• Depression
• Depressive Disorder
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Cognitive Behavioral Therapy
12 weeks cognitive-behavioral lessons, once a week
• Pulmonary Rehabilitation Therapy
12 weeks pulmonary rehabilitation exercise
• Combined Therapy
cognitive-behavioral lessons and pulmonary rehabilitation exercise for 12 weeks

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale	total score	12 weeks
Secondary	moderate and severe COPD exacerbations	total times	3 years
Secondary	modified British medical research council score	total score	3 years
Secondary	COPD assessment test score	total score	3 years