The Momentum Course: A randomised controlled trial of a remotely-delivered health behaviour change intervention for adults with cardiovascular disease or risk and depression or anxiety symptoms

In this randomised controlled trial, participants will receive access to an 6-week internet-delivered intervention, 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 6 weeks, alongside clinical support from a registered mental health clinician. The 6 weeks of the course are followed by a 12 week period where participants engage in additional optional "booster" clinical contact with the study clinician. The Momentum Course consists of: 1. 4 modules, delivered over 6 weeks. Module content is structured around four themes informed by the Health Action Process Approach (HAPA) model of health behaviour change and Cognitive Behaviour Therapy (CBT): (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 6 weeks, and should take participants 20-30 minutes 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. 2. 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). 3. Additional Resources (articles in PDF format) providing information about different problems people often struggle with, including managing sleep, managing unhelpful eating patterns, etc. 4. All participants are also provided access to brief, up to weekly support from a registered mental health clinician alongside the intervention, which is provided either via telephone or a secure messaging system. The clinician's role is to support people through the intervention, help tailor the intervention to their particular difficulties, encourage skills practice and answer questions. Clinician 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 trial clinician, 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). Adherence to the intervention is monitored via the study's secure web platform, which records information such as the number of participant logins, modules accessed; time spent completing each module; and number of downloads of additional resources. Accelerometer data collection All participants will be asked at initial assessment if they would be willing to use a wrist-worn accelerometer, should they be selected for this study sub-component (noting that this does not represent an inclusion/exclusion criterion for the RCT). Of those willing, an equal number will be randomised to accelerometer wear within the treatment and control group. This step is necessary given that only a small number of accelerometers are available. Participants will be asked to wear the devices for 7 continuous days at pre-treatment, post-treatment, and 12-week follow-up. The devices are research-grade triaxial Axivity Ax3 accelerometers (https://axivity.com/product/ax3) housed within a silicone wrist band. These devices do not have a display, and in the current research they will be used solely for data logging purposes. Adherence will be monitored via days of valid wear (>=3, including at least one day of the weekend, similar to the UK Biobank study which also used AX3 devices).