The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The First Affiliated Hospital of Guangzhou Medical University
Sponsor:
Information provided by (Responsible Party):
yonghua gao, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01688180
First received: September 14, 2012
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

Patients with chronic diseases are at great risk of depression and anxiety.It is known that depression and anxiety are one of the most common comorbidities associated with chronic lung diseases such as asthma and chronic obstructive pulmonary disease.

However,to date,little is known about the rates and risk factors of depression and anxiety symptoms in non-CF bronchiectasis;and no large-scale prospective studies have been performed to investigate the effect of depression and anxiety on the healthy outcomes(such as number of exacerbations and hospitalizations over the ensuing year).Our purpose is to fill these gaps.


Condition
Bronchiectasis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • To evaluate the impact of depression and anxiety symptoms on non-CF bronchiectasis health outcomes. [ Time Frame: one year ] [ Designated as safety issue: No ]
    Depression and anxiety are assessed at baseline using the Hospital Anxiety and Depression Scale(HADS).Health-related quality of life(HRQL) is measured using St.George's Respiratory Questionnaire(SGRQ), Leicester cough questionnaire(LCQ) and COPD assessment test(CAT) at baseline and follow-up.In the ensuing year,patients are monitored monthly by telephnone for 12 months to document the occurrence and characteristics of non-CF bronchiectasis exacerbations and hospitalizations.Patients are also encouraged to report to their investigators and research nurses whenever they experience symptom worsening.An exacerbation was defined as persistent (>24 hour) deterioration in at least three respiratory symptoms (including cough,dyspnoea, haemoptysis, increased sputum purulence or volume, and chest pain), with or without fever (>37.5˚ C),radiographic deterioration, systemic disturbances, or deterioration in chest signs.


Secondary Outcome Measures:
  • To estimate the prevalence of anxiety and depression symptoms in patients with non-CF bronchiectasis [ Time Frame: six months ] [ Designated as safety issue: No ]
    Patients with non-CF bronchiectasis will complete the HADS, a brief, reliable and valid screening measure for depression and anxiety with well-established clinical cut-off scores.The HADS consists of seven items for depression(HAD-D) and seven items for anxiety(HAD-A).The scores range from 0 to 21 for each subscale,with a score of 0-7 denoting a noncase,8-10 a possible case,and 11 or higher a probable case.


Other Outcome Measures:
  • To identify risk factors associated with symptoms of depression and anxiety in patients with non-CF bronchiectasis [ Time Frame: six months ] [ Designated as safety issue: No ]
    Demographic and clinical variables are collected ,including age,sex, body mass index(BMI),educational level,employment status,marital/partner status,amount of sputum produced daily,recent hemoptysis history,exacerbations in the previous year,6-minute walk test(6MWT),HRCT score,spirometry and sputum samples for microbiologic analysis at baseline.Some of these variables are collected again during the follow-up.


Estimated Enrollment: 160
Study Start Date: December 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Non-CF bronchiectasis is a long-term condition which affects the lungs.It is characterized by chronic airway infection with periodic exacerbations which are associated with impaired lung function, reduced quality of life and increased healthcare costs.Depression and anxiety are common and are known to be associated with poor quality of life and exacerbations of other chronic respiratory diseases such as COPD.Studies in COPD have shown that psychological distress is increasingly elevated and common,with up to 55% of patients suffering from a clinical diagnosis of anxiety and/or depression;moreover,patients with anxiety and/or depression were at greater risk for COPD-related exacerbations.Unfortunately,there has been no systematic evaluation of symptoms of depression and anxiety in patients with non-CF bronchiectasis or their relationship to health outcomes.A study including 111 non-CF bronchiectasis patients,O'Leary and colleagues indentified that 34% of patients had elevated scores for anxiety, depression or both.In a recent study of 93 patients(including 43 with Cystic fibrosis)of bronchiectasis,20% patients had elevated depression-related scores and 38 % had elevated anxiety-related scores,both depression and anxiety symptoms predicted significantly worse health-related quality of life.

To date,the studies of depression and anxiety symptoms in patients with non-CF bronchiectasis have been limited by small samples sizes;and no prospective studies have been conducted to investigate the impact of psychological distress on the health outcomes.Given the importance of identifying and treating these symptoms, and their implications for long-term health outcomes,we plan to determine the prevalence and risk factors of depression and anxiety in non-CF bronchiectasis.In addition,we investigate the effect of depression and anxiety on the risk of non-CF bronchiectasis exacerbations and hospitalizations.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adults with non-CF bronchiectasis attending the First Affiliated Hospital of Guangzhou Medical College,Guangzhou,Guangdong,China

Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. HRCT diagnosed Bronchiectasis
  3. No fever,no worsening of respiratory symptoms,and no medication change within the 4 weeks before recruitment.
  4. Capable of providing written informed consent

Exclusion Criteria:

  1. cystic fibrosis
  2. Previous lung transplantation
  Contacts and Locations
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: NCT01688180

Contacts
Contact: yonghua gao, PHD 008615836704735 gaoyonghuahust@163.com
Contact: gang xu, PHD 008613580375817 158572962@qq.com

Locations
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yonghua Gao, PHD    008615920489217    gaoyonghuahust@163.com   
Contact: Rongchang Chen, Professor    008613902273260    Chenrc@vip.163.com   
Principal Investigator: rongchang Chen, MM         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
Study Director: Yongchang Chen, professor The First Affiliated Hospital of Guangzhou Medical University
Study Chair: Nanshan Zhong, Professor The First Affiliated Hospital of Guangzhou Medical University
  More Information

No publications provided

Responsible Party: yonghua gao, PHD, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01688180     History of Changes
Other Study ID Numbers: Yonghua Gao
Study First Received: September 14, 2012
Last Updated: August 6, 2013
Health Authority: China: Ethics Committee

Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
bronchiectasis
depression
anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Bronchiectasis
Depression
Depressive Disorder
Mental Disorders
Bronchial Diseases
Respiratory Tract Diseases
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on September 14, 2014