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Trial registered on ANZCTR


Registration number
ACTRN12620000093987
Ethics application status
Approved
Date submitted
18/12/2019
Date registered
4/02/2020
Date last updated
4/02/2020
Date data sharing statement initially provided
4/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are Anxiety and Depression Associated Psychological Traits in Severe asthma?
Scientific title
Are Anxiety and Depression Associated Psychological Traits in Severe asthma?
Secondary ID [1] 300014 0
None
Universal Trial Number (UTN)
Trial acronym
The ADAPTS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe asthma 315501 0
Anxiety 315502 0
Depression 315503 0
Condition category
Condition code
Respiratory 313789 313789 0 0
Asthma
Mental Health 313790 313790 0 0
Anxiety
Mental Health 313791 313791 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 316408 0
Not applicable
Comparator / control treatment
No comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322356 0
Total score on Hospital Anxiety and Depression Scale
(Questionnarie)
Timepoint [1] 322356 0
Phase 1 and Phase 2 - At interview
Primary outcome [2] 322357 0
Total score Asthma Quality of Life Questionnaire
Timepoint [2] 322357 0
Phase 1 - At interview
Primary outcome [3] 322358 0
Total score Severe Asthma Questionnaire
Timepoint [3] 322358 0
Phase 1 - At interview
Secondary outcome [1] 378205 0
Total score Asthma Control Questionnaire
Timepoint [1] 378205 0
Phase 1 & Phase 2 - At interview
Secondary outcome [2] 378206 0
Total score Fatigue Assessment Scale
(Questionnaire)
Timepoint [2] 378206 0
Phase 1 - At interview
Secondary outcome [3] 378207 0
Total score Penn State Worry Questionnaire
Timepoint [3] 378207 0
Phase 1 - At interview
Secondary outcome [4] 378208 0
Total score Resilience Scale
(Questionanaire)
Timepoint [4] 378208 0
Phase 1 - At interview
Secondary outcome [5] 378209 0
Total score Insomnia Severity Index
(Questionnaire)
Timepoint [5] 378209 0
Phase 1 - At interview
Secondary outcome [6] 378834 0
Perceived Control of Asthma Questionnaire
Timepoint [6] 378834 0
Phase 2 - At Interview
Secondary outcome [7] 378835 0
Brief Illness Perception Questionnaire
Timepoint [7] 378835 0
Phase 2 - At Interview
Secondary outcome [8] 378836 0
Quality of Life (EQ-5D-5L)
(Questionnaire)
Timepoint [8] 378836 0
Phase 2 - At Interview
Secondary outcome [9] 379479 0
Map common themes emerging from artwork using the Common-Sense Model of Self-Regulation
Timepoint [9] 379479 0
Data analysis

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Quantitative data: Descriptive statistics will be calculated to describe demographic and clinical characteristics of the sample showing measures of dispersion and centrality (mean, median, standard deviation or interquartile range where appropriate).

Qualitative data: Recordings will be transcribed verbatim and transcripts will be anonymised and entered into NVivo to assist data management and coding. Pseudonyms will be used when referring to participants. Initial descriptive coding will be performed, which will progress to inductive pattern coding and synthesis of data into themes and subthemes. To ensure accurate representation of the interview content, themes will be repeatedly checked. As each interview is conducted, analysis will be carried out iteratively. Comparison, charting and mapping will occur for cross-case examination that will assist in interpretation. Dependability and confirmability to ensure the trustworthiness of this research will be undertaken via audit trail with records of the research path being kept during the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15542 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 28911 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 304467 0
Government body
Name [1] 304467 0
National Health and Medical Research Council
Address [1] 304467 0
16 Marcus Clarke Street, Canberra, ACT 2601
Country [1] 304467 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 304738 0
None
Name [1] 304738 0
Address [1] 304738 0
Country [1] 304738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304900 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304900 0
Locked Bag 1, NEW LAMBTON, NSW 2305
Ethics committee country [1] 304900 0
Australia
Date submitted for ethics approval [1] 304900 0
20/09/2019
Approval date [1] 304900 0
12/11/2019
Ethics approval number [1] 304900 0
2019/ETH12553

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98582 0
Prof Vanessa McDonald
Address 98582 0
The University of Newcastle
Centre of Excellence in Severe Asthma
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit,
New Lambton Heights, NSW 2305
Country 98582 0
Australia
Phone 98582 0
+6102 4042 0146
Fax 98582 0
Email 98582 0
vanessa.mcdonald@newcastle.edu.au
Contact person for public queries
Name 98583 0
Miss Michelle Stubbs
Address 98583 0
The University of Newcastle
Centre of Excellence in Severe Asthma
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit,
New Lambton Heights, NSW 2305
Country 98583 0
Australia
Phone 98583 0
+6102 4042 0104
Fax 98583 0
Email 98583 0
michelle.stubbs@newcastle.edu.au
Contact person for scientific queries
Name 98584 0
Prof Vanessa McDonald
Address 98584 0
The University of Newcastle
Centre of Excellence in Severe Asthma
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit,
New Lambton Heights, NSw 2305
Country 98584 0
Australia
Phone 98584 0
+6102 4042 0146
Fax 98584 0
Email 98584 0
vanessa.mcdonald@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results