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Are Anxiety and Depression Associated Psychological Traits in Severe asthma?

Are Anxiety and Depression Associated Psychological Traits in Severe asthma?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000093987
Acronym
The ADAPTS Study
Enrollment
50
Registered
2020-02-04
Start date
2019-12-18
Completion date
2020-10-16
Last updated
2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Symptoms of anxiety and depression are highly prevalent among people with severe asthma. Despite this, symptoms of anxiety and depression are not frequently assessed in severe asthma management. Due to the high burden and potential under treatment, further investigation is warranted. Aims: o To determine the illness burden of patients with severe asthma and anxiety and depression using patient reported outcome measures o To inform the development of a targeted non-pharmacological intervention for anxiety and depression in a severe asthma population. o To capture emotions and explore the intimate and individual experience of living with severe asthma, anxiety and/or depression through art-based methods.

Interventions

Phase 1: Assessment of clinical characteristics will be undertaken during a 2 hour interview with a PhD student who is also a registered nurse and sessional academic. Clinical characteristics include anxiety and depression, quality of life, symptoms and burden of severe asthma, fatigue, worry, resilience and insomina. A one-off interview follows completion of questionnaires focused on patient-preferred non-pharmacological interventions to reduce symptoms of anxiety and depression. Phase 2: Quest

Phase 1: Assessment of clinical characteristics will be undertaken during a 2 hour interview with a PhD student who is also a registered nurse and sessional academic. Clinical characteristics include anxiety and depression, quality of life, symptoms and burden of severe asthma, fatigue, worry, resilience and insomina. A one-off interview follows completion of questionnaires focused on patient-preferred non-pharmacological interventions to reduce symptoms of anxiety and depression. Phase 2: Questionnaires will be administered to gather data on anxiety and depression, asthma control, illness perception and quality of life. An arts-based activity follows with participants selecting from several mediums such as acrylics, watercolours, pastels, coloured pencils, markers and mixed media to create artworks. The purpose of this activity is to map the data emerging from artwork according to the Common-Sense Model of Self-Regulation. This one-off session may take 2 hours to complete. Phase 1 and Phase 2 may be undertaken on the same day (with a break inbetween sessions) or are held 1-2 weeks apart, or at the participants availablility.

Sponsors

The University of Newcastle
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

o 18 years of age or older o Confirmed diagnosis of severe asthma o Severe 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. o Prescribed 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 o Requires a monoclonal antibody (mAb) therapy to control asthma or remains uncontrolled despite a mAb. AND o Have uncontrolled asthma determined by: o scores on the Asthma Control Questionnaire that equal a score of 1.5 or above; o and/or frequent severe exacerbations (where 2 courses of administered systemic corticosteroids are evident for 3 or more days each in the previous year); o and/or a serious exacerbation in the previous year (hospitalisation, intensive care unit stay, mechanical ventilation); o and/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

o Aged less than 18 years o Non-English speaking o Cognitive impairment including a diagnosis of dementia and delirium o Diagnosed acute psychosis that includes symptoms of hallucinations and delusions o Inability to attend study visits o Not willing or able to provide consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026