search
Back to results

Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression

Primary Purpose

COPD, Anxiety, Depression

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Pulmonary Rehabilitation Therapy
Combined Therapy
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy

Pulmonary Rehabilitation Therapy

Combined Therapy

Regular Therapy

Arm Description

receive cognitive-behavioral therapy for 12 weeks

receive pulmonary rehabilitation therapy for 12 weeks

receive both cognitive-behavioral therapy and pulmonary rehabilitation therapy for 12 weeks

receive regular therapy for chronic obstructive pulmonary disease

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale
total score

Secondary Outcome Measures

moderate and severe COPD exacerbations
total times
modified British medical research council score
total score
COPD assessment test score
total score

Full Information

First Posted
June 13, 2017
Last Updated
June 13, 2017
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03187249
Brief Title
Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression
Official Title
Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
receive cognitive-behavioral therapy for 12 weeks
Arm Title
Pulmonary Rehabilitation Therapy
Arm Type
Experimental
Arm Description
receive pulmonary rehabilitation therapy for 12 weeks
Arm Title
Combined Therapy
Arm Type
Experimental
Arm Description
receive both cognitive-behavioral therapy and pulmonary rehabilitation therapy for 12 weeks
Arm Title
Regular Therapy
Arm Type
No Intervention
Arm Description
receive regular therapy for chronic obstructive pulmonary disease
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
12 weeks cognitive-behavioral lessons, once a week
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary Rehabilitation Therapy
Intervention Description
12 weeks pulmonary rehabilitation exercise
Intervention Type
Behavioral
Intervention Name(s)
Combined Therapy
Intervention Description
cognitive-behavioral lessons and pulmonary rehabilitation exercise for 12 weeks
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
total score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
moderate and severe COPD exacerbations
Description
total times
Time Frame
3 years
Title
modified British medical research council score
Description
total score
Time Frame
3 years
Title
COPD assessment test score
Description
total score
Time Frame
3 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiangna Han, MD
Phone
13520053104
Email
13520053104@139.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangna Han, MD
Phone
13520053104
Email
13520053104@139.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression

We'll reach out to this number within 24 hrs