Clinical trial NCT01688180: The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis
Official title: The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Keywords: bronchiectasis
depression
anxiety
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with non-CF bronchiectasis attending the First Affiliated Hospital of Guangzhou Medical College,Guangzhou,Guangdong,China

Brief summary: 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.

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 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

Primary outcomes:
measure: To evaluate the impact of depression and anxiety symptoms on non-CF bronchiectasis health outcomes.
timeFrame: one year
Secondary outcomes:
measure: To estimate the prevalence of anxiety and depression symptoms in patients with non-CF bronchiectasis
timeFrame: six months
Other outcomes:
measure: To identify risk factors associated with symptoms of depression and anxiety in patients with non-CF bronchiectasis
timeFrame: six months
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Yongchang Chen, professor
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Nanshan Zhong, Professor
role: STUDY_CHAIR
References:
citation: 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.