<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01688180</url>
  </required_header>
  <id_info>
    <org_study_id>Yonghua Gao</org_study_id>
    <nct_id>NCT01688180</nct_id>
  </id_info>
  <brief_title>The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis</brief_title>
  <official_title>The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Guangzhou Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with chronic diseases are at great risk of depression and anxiety.It is known that&#xD;
      depression and anxiety are one of the most common comorbidities associated with chronic lung&#xD;
      diseases such as asthma and chronic obstructive pulmonary disease.&#xD;
&#xD;
      However,to date,little is known about the rates and risk factors of depression and anxiety&#xD;
      symptoms in non-CF bronchiectasis;and no large-scale prospective studies have been performed&#xD;
      to investigate the effect of depression and anxiety on the healthy outcomes(such as number of&#xD;
      exacerbations and hospitalizations over the ensuing year).Our purpose is to fill these gaps.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-CF bronchiectasis is a long-term condition which affects the lungs.It is characterized by&#xD;
      chronic airway infection with periodic exacerbations which are associated with impaired lung&#xD;
      function, reduced quality of life and increased healthcare costs.Depression and anxiety are&#xD;
      common and are known to be associated with poor quality of life and exacerbations of other&#xD;
      chronic respiratory diseases such as COPD.Studies in COPD have shown that psychological&#xD;
      distress is increasingly elevated and common,with up to 55% of patients suffering from a&#xD;
      clinical diagnosis of anxiety and/or depression;moreover,patients with anxiety and/or&#xD;
      depression were at greater risk for COPD-related exacerbations.Unfortunately,there has been&#xD;
      no systematic evaluation of symptoms of depression and anxiety in patients with non-CF&#xD;
      bronchiectasis or their relationship to health outcomes.A study including 111 non-CF&#xD;
      bronchiectasis patients,O'Leary and colleagues indentified that 34% of patients had elevated&#xD;
      scores for anxiety, depression or both.In a recent study of 93 patients(including 43 with&#xD;
      Cystic fibrosis)of bronchiectasis,20% patients had elevated depression-related scores and 38&#xD;
      % had elevated anxiety-related scores,both depression and anxiety symptoms predicted&#xD;
      signiﬁcantly worse health-related quality of life.&#xD;
&#xD;
      To date,the studies of depression and anxiety symptoms in patients with non-CF bronchiectasis&#xD;
      have been limited by small samples sizes;and no prospective studies have been conducted to&#xD;
      investigate the impact of psychological distress on the health outcomes.Given the importance&#xD;
      of identifying and treating these symptoms, and their implications for long-term health&#xD;
      outcomes,we plan to determine the prevalence and risk factors of depression and anxiety in&#xD;
      non-CF bronchiectasis.In addition,we investigate the effect of depression and anxiety on the&#xD;
      risk of non-CF bronchiectasis exacerbations and hospitalizations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Anticipated">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the impact of depression and anxiety symptoms on non-CF bronchiectasis health outcomes.</measure>
    <time_frame>one year</time_frame>
    <description>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 (&gt;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 (&gt;37.5˚ C),radiographic deterioration, systemic disturbances, or deterioration in chest signs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To estimate the prevalence of anxiety and depression symptoms in patients with non-CF bronchiectasis</measure>
    <time_frame>six months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To identify risk factors associated with symptoms of depression and anxiety in patients with non-CF bronchiectasis</measure>
    <time_frame>six months</time_frame>
    <description>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.</description>
  </other_outcome>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Bronchiectasis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with non-CF bronchiectasis attending the First Affiliated Hospital of Guangzhou&#xD;
        Medical College,Guangzhou,Guangdong,China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years&#xD;
&#xD;
          2. HRCT diagnosed Bronchiectasis&#xD;
&#xD;
          3. No fever,no worsening of respiratory symptoms,and no medication change within the 4&#xD;
             weeks before recruitment.&#xD;
&#xD;
          4. Capable of providing written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. cystic fibrosis&#xD;
&#xD;
          2. Previous lung transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yongchang Chen, professor</last_name>
    <role>Study Director</role>
    <affiliation>The First Affiliated Hospital of Guangzhou Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nanshan Zhong, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>The First Affiliated Hospital of Guangzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>yonghua gao, PHD</last_name>
    <phone>008615836704735</phone>
    <email>gaoyonghuahust@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>gang xu, PHD</last_name>
    <phone>008613580375817</phone>
    <email>158572962@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yonghua Gao, PHD</last_name>
      <phone>008615920489217</phone>
      <email>gaoyonghuahust@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Rongchang Chen, Professor</last_name>
      <phone>008613902273260</phone>
      <email>Chenrc@vip.163.com</email>
    </contact_backup>
    <investigator>
      <last_name>rongchang Chen, MM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>August 6, 2013</last_update_submitted>
  <last_update_submitted_qc>August 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Guangzhou Medical University</investigator_affiliation>
    <investigator_full_name>yonghua gao</investigator_full_name>
    <investigator_title>PHD</investigator_title>
  </responsible_party>
  <keyword>bronchiectasis</keyword>
  <keyword>depression</keyword>
  <keyword>anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiectasis</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01688180
org study id: Yonghua Gao
nct id: NCT01688180
lead sponsor: 
has dmc: Yes
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 model: Case-Control
time perspective: Prospective
measure: To evaluate the impact of depression and anxiety symptoms on non-CF bronchiectasis health outcomes.
time frame: one year
description: 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.
measure: To estimate the prevalence of anxiety and depression symptoms in patients with non-CF bronchiectasis
time frame: six months
description: 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.
measure: To identify risk factors associated with symptoms of depression and anxiety in patients with non-CF bronchiectasis
time frame: six months
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yongchang Chen, professor
role: Study Director
affiliation: The First Affiliated Hospital of Guangzhou Medical University
last name: Nanshan Zhong, Professor
role: Study Chair
affiliation: The First Affiliated Hospital of Guangzhou Medical University
last name: yonghua gao, PHD
phone: 008615836704735
email: gaoyonghuahust@163.com
last name: gang xu, PHD
phone: 008613580375817
email: 158572962@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Guangzhou Medical University
investigator full name: yonghua gao
investigator title: PHD
mesh term: Bronchiectasis
mesh term: Depression