None listed
Conditions
Brief summary
Cardiovascular disease is one of the leading causes of illness and death in Australia and worldwide. Around 1 in 3 people with cardiovascular disease or at higher risk of developing it also experience poor emotional health, such as anxiety or low mood. These emotional difficulties can make cardiovascular health worse and make it harder for people to change important health behaviours, like improving their diet or being more active. This study will test how practical and acceptable it is to offer a new program that supports both health behaviour change and emotional wellbeing for people with cardiovascular disease or increased risk who also experience poor emotional wellbeing. The program is a short, internet-based course that teaches skills for improving health behaviours, while also providing strategies to manage emotional wellbeing. Participants will be supported by a psychologist during the course, with optional follow-up support for up to 12 weeks afterwards. We expect that participants will find the program acceptable, will stay engaged with the treatment, and will complete the study measures. We will also gather early evidence of its effects using questionnaires and a wrist-worn device that measures movement. Participants will also be invited to participate in interviews about the program.
Interventions
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
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
Sponsors
Macquarie University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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..
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.
Outcome results
None listed