Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression


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Verified June 2017 by Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital

Sponsor:

Information provided by (Responsible Party):

Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital

ClinicalTrials.gov Identifier:

NCT03187249

First received: June 13, 2017

Last updated: June 13, 2017

Last verified: June 2017

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.

COPD
Anxiety
Depression
Behavioral: Cognitive Behavioral Therapy
Behavioral: Pulmonary Rehabilitation Therapy
Behavioral: Combined Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression

Primary Outcome Measures:

  • Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ]

    total score

Secondary Outcome Measures:

  • moderate and severe COPD exacerbations [ Time Frame: 3 years ]

    total times

  • modified British medical research council score [ Time Frame: 3 years ]

    total score

  • COPD assessment test score [ Time Frame: 3 years ]

    total score

Estimated Enrollment: 500
Anticipated Study Start Date: June 15, 2017
Estimated Study Completion Date: December 31, 2020
Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03187249

Peking Union Medical College Hospital
Beijing, Beijing, China, 100032
Contact: Jiangna Han, MD    13520053104    13520053104@139.com   

Chinese Academy of Medical Sciences, Fuwai Hospital

Responsible Party: Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03187249     History of Changes
Other Study ID Numbers: 2016YFC1304404B
Study First Received: June 13, 2017
Last Updated: June 13, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression
Depressive Disorder
Lung Diseases
Anxiety Disorders
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 14, 2017