Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression
1 other identifier
interventional
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJune 14, 2017
June 1, 2017
3.5 years
June 13, 2017
June 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Hospital Anxiety and Depression Scale
total score
12 weeks
Secondary Outcomes (3)
moderate and severe COPD exacerbations
3 years
modified British medical research council score
3 years
COPD assessment test score
3 years
Study Arms (4)
Cognitive Behavioral Therapy
EXPERIMENTALreceive cognitive-behavioral therapy for 12 weeks
Pulmonary Rehabilitation Therapy
EXPERIMENTALreceive pulmonary rehabilitation therapy for 12 weeks
Combined Therapy
EXPERIMENTALreceive both cognitive-behavioral therapy and pulmonary rehabilitation therapy for 12 weeks
Regular Therapy
NO INTERVENTIONreceive regular therapy for chronic obstructive pulmonary disease
Interventions
12 weeks cognitive-behavioral lessons, once a week
12 weeks pulmonary rehabilitation exercise
cognitive-behavioral lessons and pulmonary rehabilitation exercise for 12 weeks
Eligibility Criteria
You may qualify if:
- Stable COPD patients with mild or moderate anxiety and depression
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Pulmonary Vascular Disease Center
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 14, 2017
Study Start
June 15, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
June 14, 2017
Record last verified: 2017-06