ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01688180
Recruitment Status : Unknown
Verified August 2013 by yonghua gao, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : September 19, 2012
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
yonghua gao, The First Affiliated Hospital of Guangzhou Medical University

September 14, 2012
September 19, 2012
August 7, 2013
December 2012
May 2014   (Final data collection date for primary outcome measure)
To evaluate the impact of depression and anxiety symptoms on non-CF bronchiectasis health outcomes. [ Time Frame: one year ]
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.
To evaluate the impact of depression and anxiety symptoms on non-CF bronchiectasis health outcomes. [ Time Frame: one year ]
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) and Leicester cough questionnaire(LCQ)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.
Complete list of historical versions of study NCT01688180 on ClinicalTrials.gov Archive Site
To estimate the prevalence of anxiety and depression symptoms in patients with non-CF bronchiectasis [ Time Frame: six months ]
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.
Same as current
To identify risk factors associated with symptoms of depression and anxiety in patients with non-CF bronchiectasis [ Time Frame: six months ]
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.
Same as current
 
The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis
The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Adults with non-CF bronchiectasis attending the First Affiliated Hospital of Guangzhou Medical College,Guangzhou,Guangdong,China
Bronchiectasis
Not Provided
Not Provided
Gao YH, Guan WJ, Xu G, Gao Y, Lin ZY, Tang Y, Lin ZM, Li HM, Luo Q, Zhong NS, Birring SS, Chen RC. Validation of the Mandarin Chinese version of the Leicester Cough Questionnaire in bronchiectasis. Int J Tuberc Lung Dis. 2014 Dec;18(12):1431-7. doi: 10.5588/ijtld.14.0195.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
160
322
May 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01688180
Yonghua Gao
Yes
Not Provided
Not Provided
yonghua gao, The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
Not Provided
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
The First Affiliated Hospital of Guangzhou Medical University
August 2013