Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression

June 13, 2017 updated by: Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Therapy
receive cognitive-behavioral therapy for 12 weeks
Behavioral: Cognitive Behavioral Therapy
12 weeks cognitive-behavioral lessons, once a week
Experimental: Pulmonary Rehabilitation Therapy
receive pulmonary rehabilitation therapy for 12 weeks
Behavioral: Pulmonary Rehabilitation Therapy
12 weeks pulmonary rehabilitation exercise
Experimental: Combined Therapy
receive both cognitive-behavioral therapy and pulmonary rehabilitation therapy for 12 weeks
Behavioral: Combined Therapy
cognitive-behavioral lessons and pulmonary rehabilitation exercise for 12 weeks
No Intervention: Regular Therapy
receive regular therapy for chronic obstructive pulmonary disease

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016YFC1304404B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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