BronchiectasisNCT01688180
The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis
An observational study of Bronchiectasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with non-CF bronchiectasis attending the First Affiliated Hospital of Guangzhou Medical College,Guangzhou,Guangdong,China
Who may be able to join
- Age ≥18 years
- HRCT diagnosed Bronchiectasis
- No fever,no worsening of respiratory symptoms,and no medication change within the 4 weeks before recruitment.
- Capable of providing written informed consent
Who cannot join
- cystic fibrosis
- Previous lung transplantation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Yonghua Gao, PHD, 008615920489217, gaoyonghuahust@163.com
Rongchang Chen, Professor, 008613902273260, Chenrc@vip.163.com
About this study
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.
Read the 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.
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, depression, anxiety
- Medical subject headings
- Bronchiectasis, Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of depression and anxiety symptoms on non-CF bronchiectasis health outcomes.
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.
Measured: one year
Secondary outcomes (1)
To estimate the prevalence of anxiety and depression symptoms in patients with non-CF bronchiectasis
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yonghua gao, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Yongchang Chen, professor, Study director, The First Affiliated Hospital of Guangzhou Medical UniversityNanshan Zhong, Professor, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688180
- Sponsor's protocol ID
- Yonghua Gao
- Status last verified
- Aug 2013
- First submitted
- 14 Sep 2012
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25517807
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis
- ClinicalTrials.gov ID
- NCT01688180
- Acronym / sponsor ID
- Yonghua Gao
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, depression, anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with non-CF bronchiectasis attending the First Affiliated Hospital of Guangzhou Medical College,Guangzhou,Guangdong,China
Key inclusion criteria (4 listed)
- Age ≥18 years
- HRCT diagnosed Bronchiectasis
- No fever,no worsening of respiratory symptoms,and no medication change within the 4 weeks before recruitment.
- Capable of providing written informed consent
Key exclusion criteria (2 listed)
- cystic fibrosis
- Previous lung transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
To estimate the prevalence of anxiety and depression symptoms in patients with non-CF bronchiectasis
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 25517807Gao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongchang Chen, professor study director
The First Affiliated Hospital of Guangzhou Medical University
Nanshan Zhong, Professor study chair
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yonghua gao, PHD (008615836704735, gaoyonghuahust@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of depression and anxiety symptoms on non-CF bronchiectasis health outcomes. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01688180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013; AzTrials last refreshed its copy on 8 Nov 2026.