Are Anxiety and Depression Associated Psychological Traits in Severe asthma?

Not Applicable

Completed

• Conditions: Severe asthma; Anxiety; Depression; Respiratory - Asthma; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12620000093987
• Lead Sponsor: The University of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-04
• Study Completion: 2020-10-16
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

o18 years of age or older
oConfirmed diagnosis of severe asthma
oSevere asthma is defined according to International European Respiratory Society and American Thoracic Society Guidelines as asthma requiring high-dose inhaled corticosteroids with a second controller to prevent uncontrolled” disease or disease that remains uncontrolled” despite therapy.
oPrescribed high-dose inhaled corticosteroids (above 1000µg beclomethasone equivalent) PLUS a second controller (may include long-acting beta agonists; and/or long-acting muscarinic antagonists, and/or maintenance oral corticosteroids for 50% of the past year; and/or montelukast; and/or theophylline).

OR

oRequires a monoclonal antibody (mAb) therapy to control asthma or remains uncontrolled despite a mAb.
AND
oHave uncontrolled asthma determined by:
oscores on the Asthma Control Questionnaire that equal a score of 1.5 or above;
oand/or frequent severe exacerbations (where 2 courses of administered systemic corticosteroids are evident for 3 or more days each in the previous year);
oand/or a serious exacerbation in the previous year (hospitalisation, intensive care unit stay, mechanical ventilation);
oand/or persistent airflow limitation (pre-bronchodilator FEV1 of less than 80% predicted in the face of a reduced FEV1/FVC of less than 0.7).

Exclusion Criteria

oAged less than 18 years
oNon-English speaking
oCognitive impairment including a diagnosis of dementia and delirium
oDiagnosed acute psychosis that includes symptoms of hallucinations and delusions
oInability to attend study visits
oNot willing or able to provide consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total score on Hospital Anxiety and Depression Scale<br>(Questionnarie)[Phase 1 and Phase 2 - At interview];Total score Asthma Quality of Life Questionnaire[Phase 1 - At interview];Total score Severe Asthma Questionnaire[Phase 1 - At interview]

Secondary Outcome Measures

Name	Time	Method
Total score Asthma Control Questionnaire[Phase 1 & Phase 2 - At interview];Total score Fatigue Assessment Scale<br>(Questionnaire)[Phase 1 - At interview];Total score Penn State Worry Questionnaire[Phase 1 - At interview];Total score Resilience Scale<br>(Questionanaire)[Phase 1 - At interview];Total score Insomnia Severity Index<br>(Questionnaire)[Phase 1 - At interview];Perceived Control of Asthma Questionnaire[Phase 2 - At Interview];Brief Illness Perception Questionnaire[Phase 2 - At Interview];Quality of Life (EQ-5D-5L)<br>(Questionnaire)[Phase 2 - At Interview];Map common themes emerging from artwork using the Common-Sense Model of Self-Regulation[Data analysis]