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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03187249
Other study ID # 2016YFC1304404B
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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