Intervention Strategy in Chronic Obstructive Pulmonary Di... | NCT03187249

Studies
Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression

NCT03187249

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Unknown status

Last Update Posted

Jun 14, 2017Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

COPD
Anxiety
Depression

Interventions

Cognitive Behavioral Therapy
Pulmonary Rehabilitation Therapy
Combined Therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2017Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jun 13, 2017

First Submission Date that Met QC Criteria

Jun 13, 2017

First Posted Date

Jun 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2017

Last Update Posted Date

Jun 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive Behavioral Therapy	Experimental	receive cognitive-behavioral therapy for 12 weeks	Behavioral: Cognitive Behavioral Therapy
Pulmonary Rehabilitation Therapy	Experimental	receive pulmonary rehabilitation therapy for 12 weeks	Behavioral: Pulmonary Rehabilitation Therapy
Combined Therapy	Experimental	receive both cognitive-behavioral therapy and pulmonary rehabilitation therapy for 12 weeks	Behavioral: Combined Therapy
Regular Therapy	No Intervention	receive regular therapy for chronic obstructive pulmonary disease

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Behavioral Therapy	Behavioral	12 weeks cognitive-behavioral lessons, once a week	Cognitive Behavioral Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital Anxiety and Depression Scale	total score	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
moderate and severe COPD exacerbations	total times	3 years
modified British medical research council score	total score	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiangna Han, MD	Contact	13520053104		13520053104@139.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality	100032	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D001008	Anxiety Disorders
D003863	Depression

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015928	Cognitive Behavioral Therapy
D011616	Psychotherapy, Multiple

Ancestor Terms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided