Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000430437
Ethics application status
Approved
Date submitted
24/04/2025
Date registered
9/05/2025
Date last updated
9/05/2025
Date data sharing statement initially provided
9/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the feasibility and helpfulness of an internet-delivered intervention for adults with medically managed Atrial Fibrillation (AF)
Scientific title
Examining the feasibility and helpfulness of an internet-delivered intervention for adults with medically managed Atrial Fibrillation (AF)
Secondary ID [1] 314274 0
Atrial Fibrillation Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 337211 0
Depression 337210 0
Atrial Fibrillation 337209 0
Condition category
Condition code
Cardiovascular 333620 333620 0 0
Other cardiovascular diseases
Mental Health 333622 333622 0 0
Depression
Mental Health 333621 333621 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-group study. All participants will receive access to an 8 week internet-delivered, self-management course, the Chronic Conditions Course, which provides good information and skills for managing the impacts of chronic conditions on people's emotional wellbeing and quality of life. The Chronic Conditions Course is an existing psychological treatment package that has been evaluated in several randomised controlled trials to date, and was not designed specifically for this study. The treatment package was designed by Professor Blake Dear's clinical research team.

The Chronic Conditions Course runs for 8 weeks and consists of:

(a) 5 online lessons (in the form of presentation slides) with exercises for learning the information and skills. The duration of each lesson is approximately 20 to 30 minutes. Lessons are completed in weeks 1, 2, 4, 5 and 7. Lessons can be viewed in the online platform, or downloaded as PDF files. Lessons are accompanied by lesson worksheets which can be downloaded and/or printed as PDF files. Participants are encouraged to engage with the home-based exercises at a frequency and duration that is helpful for them, though a suggested time commitment of at least 30 minutes each week is encouraged. The first lesson (in week 1) is a introduction and overview of the course, including psycho-education about chronic health conditions and emotional wellbeing. Participants are encouraged to identify their symptoms (e.g. thinking styles, physical symptoms, unhelpful habits) as a home-based exercise. Lesson 2 (week 2) introduces cognitive challenging skills, and participants are encouraged to practice thought challenging in the following two weeks. Lesson 3 (week 4) covers behavioural activation and relaxation strategies to manage mood and anxiety symptoms, and participants are provided with the resources to undertake activity scheduling as a home-based task. Lesson 4 (week 5) introduces activity pacing to manage symptoms such as pain and fatigue, and graded exposure to manage anxiety and avoidance. Following lesson 4, participants are encouraged to attempt activity pacing and/or graded exposure tasks as a home-based exercise. Finally, Lesson 5 (week 7) includes information and strategies relating to relapse prevention, and participants are given materials to help with goal-setting for the future, and also a relapse prevention plan.

(b) Automatic emails that help guide people through the course with frequency of once or twice per week. Examples of these e-mails include; reminders when new lessons are available, congratulatory messages once a lesson has been completed, brief messages that reinforce the core concepts of the lessons, and e-mails inviting contact and encouraging engagement if a participant has not logged in for a while.

(c) Additional Resources (articles in PDF format) developed specifically for this study. These resources provide information about different problems people often struggle with, including managing sleep, working with health professionals, etc.

(d) Case Stories and examples based on previous participants. These case stories are briefly incorporated into each lesson, commonly in the form of worked examples on worksheets, or participants' experiences learning and practicing the skills within the lesson. Additional case stories are example as optional materials that can be accessed by participants at their own discretion, which provide more in-depth information and experiences.

(e) All participants are also provided access to brief support from a psychologist alongside the intervention, which is provided either via telephone or a secure messaging system. The psychologist's role is to support people through the intervention, help tailor the intervention to their particular difficulties, encourage skills practice and answer questions. Psychologist support is provided based on patient preference, and can be proactively scheduled (e.g., weekly appointments) or on request and as needed.

Adherence with the intervention is monitored via the study's secure web platform, which records information such as; the number of participant log-ins, lesson completions; time spent completing each lesson; and number of downloads of additional resources. The details of the psychologist's contact with participants (type of contact, medium of contact, duration) is also recorded.
Intervention code [1] 330957 0
Treatment: Other
Intervention code [2] 330886 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341196 0
Atrial Fibrillation related Quality-Of-Life
Timepoint [1] 341196 0
Initial assessment, pre-treatment (week 1-2), mid-treatment (week 5-6), post-treatment (week 9-10) and 3-month follow-up (week 20-22). The measure is administered once at each of these time points. Primary timepoint: Post-Treatment (week 9-10)
Primary outcome [2] 341199 0
Anxiety symptoms
Timepoint [2] 341199 0
Initial assessment, pre-treatment (week 1-2), mid-treatment (week 5-6), post-treatment (week 9-10) and 3-month follow-up (week 20-22). The measure is administered once at each of these time points. Primary timepoint: Post-Treatment (week 9-10)
Primary outcome [3] 341197 0
Depression symptoms
Timepoint [3] 341197 0
Initial assessment, pre-treatment (week 1-2), mid-treatment (week 5-6), post-treatment (week 9-10) and 3-month follow-up (week 20-22). The measure is administered once at each of these time points. Primary timepoint: Post-Treatment (week 9-10)
Secondary outcome [1] 446742 0
Health and disability. This will be assessed as a composite outcome.
Timepoint [1] 446742 0
Initial assessment, pre-treatment (week 1-2), mid-treatment (week 5-6), post-treatment (week 9-10) and 3-month follow-up (week 20-22). The measure is administered once at each of these time points.
Secondary outcome [2] 446744 0
Cardiac Anxiety
Timepoint [2] 446744 0
Initial assessment, pre-treatment (week 1-2), mid-treatment (week 5-6), post-treatment (week 9-10) and 3-month follow-up (week 20-22). The measure is administered once at each of these time points.
Secondary outcome [3] 446747 0
Treatment Satisfaction
Timepoint [3] 446747 0
Post-treatment (week 9-10). The measure is administered once at each of these time points.
Secondary outcome [4] 446745 0
Treatment Credibility and Expectancy
Timepoint [4] 446745 0
Pre-treatment (week 1-2). The measure is administered once.
Secondary outcome [5] 446743 0
Atrial Fibrillation Symptoms
Timepoint [5] 446743 0
Initial assessment, pre-treatment (week 1-2), mid-treatment (week 5-6), post-treatment (week 9-10) and 3-month follow-up (week 20-22). The measure is administered once at each of these time points.

Eligibility
Key inclusion criteria
(a) Diagnosed with atrial fibrillation (AF) by a doctor
(b) If they have comorbid conditions, AF is a primary condition
(c) Medical management of atrial fibrillation is stable (no procedures or changes in medications planned)
(d) Self-reported concern about the symptoms of atrial fibrillation or their impacts
(e) Aged 18 years or older
(f) Living in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Imminent risk of suicide or unable to keep themselves safe
(b) Does not have access to an internet-connected device
(c) Unable to read and understand English
(d) Reversible cause of AF (i.e., hypothyroidism, infection, anaemia etc)
(e) Life expectancy < 2years

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
With alpha set at 0.05, power set at 0.80, the study is powered to enable the detection of large effect size (i.e., Cohen’s d > 0.70) changes in symptoms. However, the primary aim of the proposed trial is not to evaluate efficacy; instead it will provide data to inform future efficacy trials. We may recruit more participants (up to n = 50) to obtain a representative sample.

All analyses will be carried out using conservative intention-to-treat principles and appropriate models (e.g., generalised estimating equations, mixed models) for longitudinal data. Multiple Imputation will be employed to address missing data. The proportions meeting criteria for clinical improvement (i.e., >= 30% and >= 50% from baseline) will also be examined.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/05/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
26/03/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318793 0
University
Name [1] 318793 0
Macquarie University
Country [1] 318793 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 321235 0
None
Name [1] 321235 0
Address [1] 321235 0
Country [1] 321235 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317401 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 317401 0
Ethics committee country [1] 317401 0
Australia
Date submitted for ethics approval [1] 317401 0
05/11/2024
Approval date [1] 317401 0
04/12/2024
Ethics approval number [1] 317401 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140946 0
Prof Blake Dear
Address 140946 0
School of Psychological Sciences, 16 University Avenue, Macquarie University NSW 2109
Country 140946 0
Australia
Phone 140946 0
+61 2 98509979
Fax 140946 0
Email 140946 0
[email protected]
Contact person for public queries
Name 140947 0
Blake Dear
Address 140947 0
School of Psychological Sciences, 16 University Avenue, Macquarie University NSW 2109
Country 140947 0
Australia
Phone 140947 0
+61 2 98509979
Fax 140947 0
Email 140947 0
[email protected]
Contact person for scientific queries
Name 140948 0
Blake Dear
Address 140948 0
School of Psychological Sciences, 16 University Avenue, Macquarie University NSW 2109
Country 140948 0
Australia
Phone 140948 0
+61 2 98509979
Fax 140948 0
Email 140948 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: By email to the lead investigator: Blake Dear ([email protected])

Are there extra considerations when requesting access to individual participant data?
Yes: Costs, timelines, data safety and institutional approval.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.