Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001016426
Ethics application status
Approved
Date submitted
18/08/2025
Date registered
12/09/2025
Date last updated
12/09/2025
Date data sharing statement initially provided
12/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility trial of a remotely-delivered health behaviour change intervention for adults with cardiovascular disease or risk and depression or anxiety symptoms
Scientific title
Feasibility trial of a remotely-delivered health behaviour change intervention for adults with cardiovascular disease or risk and depression or anxiety symptoms
Secondary ID [1] 315143 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 338572 0
cardiovascular risk 338573 0
depression 338574 0
anxiety 338575 0
Condition category
Condition code
Cardiovascular 334874 334874 0 0
Coronary heart disease
Cardiovascular 334875 334875 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 334876 334876 0 0
Hypertension
Cardiovascular 334877 334877 0 0
Other cardiovascular diseases
Mental Health 334878 334878 0 0
Anxiety
Mental Health 334879 334879 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-group study. All participants will receive access to a 5-week internet-delivered course, the Momentum Course, which provides information and skills for making change to health-related behaviours and managing emotional wellbeing. The treatment package was designed by Dr Andreea Heriseanu and the eCentreClinic, Macquarie University.

The Momentum Course is delivered over 5 weeks, alongside clinical support from a registered psychologist. The 5 weeks of the course are followed by a 12 week period where participants engage in additional optional “booster” clinical contact with the study psychologist.

The Momentum Course consists of:

- 4 modules, delivered over 5 weeks. Module content is structured around four themes informed by the Health Action Process Approach model of health behaviour change and Cognitive Behaviour Therapy: (1) Education, (2) Behavioural skills, (3) Cognitive strategies, and (4) Relapse prevention. Modules are delivered online, they are released every week or other-week over the 5 weeks, and should take participants 20-30minutes to work through. Modules are presented as slide decks consisting of text and static images and can be viewed in the online platform, or downloaded as PDFs. The modules include detailed examples of people with different cardiovascular conditions and/or risk factors to illustrate how to integrate the skills from the Course into everyday life. Modules are accompanied by worksheets which can be downloaded and/or printed as PDF files. Participants are encouraged to engage with these home-based exercises during the week.
- Automatic emails that help guide people through the course with frequency of once or twice per week (e.g. reminders when a new module is available; congratulatory messages once a module has been completed; brief messages that reinforce the core concepts of the modules, and e-mails inviting contact and encouraging engagement).
- Additional Resources (articles in PDF format) providing information about different problems people often struggle with, including managing sleep, managing unhelpful eating patterns, etc.
- All participants are also provided access to brief weekly 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. In the 12-week period following the course, participants have the option of continuing to engage in “booster” clinical contact with the study psychologist, with the purpose of encouraging skills practice in the longer term. This contact is similar to the support provided during the course (i.e. brief contact via telephone or secure messaging system; frequency based on participant preference and clinical need).

Adherence
Adherence to the course will be monitored via the number of logins to the platform, % of modules accessed, number of downloads of additional resources. and type and duration of contact with the psychologist is also recorded.

Questionnaires
All participants will be asked to complete questionnaire at the following timepoints:
- Pre-treatment (Week 0; 20 minutes)
- Weeks 1-5 (2 minutes)
- Week 6 (20 minutes)
- Week 18 (20 minutes)

Accelerometer
Participants will be asked to wear a research-grade wrist-worn device measuring physical activity (Axivity AX3) for 7 days at the following timepoints:
- Pre-treatment (Week 0)
- Week 6
- Week 18
Intervention code [1] 331769 0
Behaviour
Intervention code [2] 331770 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342503 0
Treatment engagement
Timepoint [1] 342503 0
Week 6 post-baseline; Week 18 post-baseline
Primary outcome [2] 342504 0
Retention
Timepoint [2] 342504 0
Week 6 post-baseline; Week 18 post-baseline
Primary outcome [3] 342505 0
Acceptability
Timepoint [3] 342505 0
Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [1] 451075 0
Recruitment
Timepoint [1] 451075 0
Upon study completion
Secondary outcome [2] 451076 0
Adverse events
Timepoint [2] 451076 0
Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [3] 451077 0
Successful use of physical activity monitors
Timepoint [3] 451077 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [4] 451078 0
Credibility and expectancy
Timepoint [4] 451078 0
Week 0 (baseline)
Secondary outcome [5] 451079 0
Objective physical activity
Timepoint [5] 451079 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [6] 451080 0
Self-reported physical activity
Timepoint [6] 451080 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [7] 451081 0
Self-reported diet quality
Timepoint [7] 451081 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [8] 451082 0
Depression symptoms
Timepoint [8] 451082 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [9] 451083 0
Anxiety symptoms
Timepoint [9] 451083 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [10] 451084 0
Depression symptoms - brief
Timepoint [10] 451084 0
Weekly for Weeks 1-5 post-baseline
Secondary outcome [11] 451085 0
Anxiety symptoms - brief
Timepoint [11] 451085 0
Weekly for Weeks 1-5 post-baseline
Secondary outcome [12] 451086 0
Health behaviour self-efficacy
Timepoint [12] 451086 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [13] 451087 0
Health behaviour check
Timepoint [13] 451087 0
Weekly for Weeks 1-5 post-baseline
Secondary outcome [14] 451088 0
Habit strength
Timepoint [14] 451088 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [15] 451089 0
Disability
Timepoint [15] 451089 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [16] 451090 0
Sleep difficulties
Timepoint [16] 451090 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [17] 451091 0
Subjective cognitive function
Timepoint [17] 451091 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [18] 451092 0
Fatigue severity and interference
Timepoint [18] 451092 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [19] 451093 0
Pain severity and interference
Timepoint [19] 451093 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline
Secondary outcome [20] 451094 0
Eating disorder symptomatology
Timepoint [20] 451094 0
Week 0 (baseline); Week 6 post-baseline; Week 18 post-baseline

Eligibility
Key inclusion criteria
(a) Self-reported stable cardiovascular disease (CVD) or risk factors for CVD, being managed by GP or medical specialist (e.g. cardiologist);
(b) Not meeting national guidelines for physical activity (less than 150 min/week of physical activity) or diet quality (less than 5 serves of vegetables and 2 serves of fruit per day, on average);
(c) Wanting information and skills to help improve health-promoting behaviours;
(d) Elevated low mood or anxiety (score of greater than or equal to 5 on the GAD-7 or PHQ-9);
(e) Aged 18 or over;
(f) Ability and willingness to comply with the study protocol..
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Current severe medical or psychiatric disorder that requires immediate treatment (e.g. current mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment);
(b) Contraindication to exercise or diet modification;
(c) Not living in Australia;
(d) Serious cognitive impairment that may impact upon ability to participate in the trial;
(e) Unable to read and understand English, and
(f) Not available to participate during the study’s treatment period;
(g) Do not have access to a computer and the internet.

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
Statistical methods / analysis
The primary aim of the proposed trial is to evaluate feasibility rather than efficacy; instead it will provide data to inform future efficacy trials.

A "traffic light" progression framework will be used for the 3 primary feasibility outcomes, where the RED zone indicates unacceptable outcomes, the GREEN zone denotes acceptable outcomes, and the AMBER zone designates potentially acceptable outcomes [1].

(1) Treatment engagement - module completion
RED zone: fewer than 50% of participants completing all 4 modules
AMBER zone: 50-84% of participants completing all 4 modules
GREEN zone: 85% or more completing all four modules.

(2) Retention - completion of the primary endpoint questionnaires
RED zone: fewer than than 60% of participants
AMBER zone: 60-89% of participants
GREEN zone: at least 90% of participants.

(3) Acceptability - response of being satisfied/very satisfied with the intervention, or that the intervention was worth their time
RED zone: less than 65% of participants
AMBER zone: 65-89% of participants
GREEN zone: 90% or more reporting this level of satisfaction.

These criteria are in line with results from previous trials conducted at the eCentreClinic and more widely, e.g. [2].

Sample size
To achieve an overall power of 80%, using a one-sided significance level of .05, the largest required sample size across the three primary outcomes is 25 participants. Therefore, we plan to recruit up to 30 participants, allowing for 20% attrition.

Analyses
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. Missing data will be addressed e.g. through Multiple Imputation.

References
[1] Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasibility Stud. 2021;7(1):40, https://doi.org/10.1186/s40814-021-00770-x.

[2] Dear B, Scott A, Fogliati R, Gandy M, Karin E, Dudeney J, et al. The Chronic Conditions Course: A randomised controlled trial of a remotely-delivered transdiagnostic psychological intervention for people with chronic health conditions Psychother Psychosom. 2021;91(4):265-76, https://doi.org/10.1159/000522530

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/10/2025
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319720 0
University
Name [1] 319720 0
Macquarie University
Country [1] 319720 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 322228 0
None
Name [1] 322228 0
Address [1] 322228 0
Country [1] 322228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318273 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 318273 0
Ethics committee country [1] 318273 0
Australia
Date submitted for ethics approval [1] 318273 0
21/07/2025
Approval date [1] 318273 0
29/08/2025
Ethics approval number [1] 318273 0

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

Contacts
Principal investigator
Name 143666 0
Dr Andreea Heriseanu
Address 143666 0
School of Psychological Sciences, 16 University Avenue, Macquarie University NSW 2109
Country 143666 0
Australia
Phone 143666 0
+61 2 9850 9656
Fax 143666 0
Email 143666 0
[email protected]
Contact person for public queries
Name 143667 0
Andreea Heriseanu
Address 143667 0
School of Psychological Sciences, 16 University Avenue, Macquarie University NSW 2109
Country 143667 0
Australia
Phone 143667 0
+61 2 9850 9656
Fax 143667 0
Email 143667 0
[email protected]
Contact person for scientific queries
Name 143668 0
Andreea Heriseanu
Address 143668 0
School of Psychological Sciences, 16 University Avenue, Macquarie University NSW 2109
Country 143668 0
Australia
Phone 143668 0
+61 2 9850 9656
Fax 143668 0
Email 143668 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:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Data will be made available following formal request via email to the chief investigator ([email protected]) using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committees involved.

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.