None listed
Conditions
Brief summary
There is growing research on using risk algorithms to identify individuals at increased risk for future mental ill-health and for prevention interventions. However, there is lack of research on the effects of communicating personal mental health risk profiles on psychological or behavioral outcomes. There is potential that personal risk profiles can cause short term distress but motivate people to modify behavior to reduce their risks. Our research team has developed a risk algorithm to predict the 12-month risk of psychological distress in working Australian adults (Fernandez et al, 2017). This study explores the impact of communicating different types of personal mental health risk profiles on psychological outcomes and engagement with a smartphone App. The aim of this study is to investigate the effect of communicating different personal mental health risk profile on psychological distress and engagement with a smartphone App (Mindtrack). The secondary aim of the study is to explore how level of risk affects the psychological outcomes and engagement. The study’s purpose is to answer three main research questions namely: (1) What is the impact of different methods of communicating personal mental health risk profile on psychological outcomes in the medium term? (2) What is the impact of different methods of communicating personal mental health risk profile on engagement with an App? (3) Is an individual’s current or achievable risk an effect modifier of these outcomes? In order to achieve these objectives, a randomized controlled non-inferiority design will compare the effects of communicating (1) their current personal risk profile or (2) achievable personal risk profile or (3) no personal risk profile on psychological outcomes and engagement in the Mindtrack App. The 3 main study hypotheses are: i) The participants provided with the current risk profile and the achievable risk profile do not have unacceptably worse levels of psychological distress (defined as the lower bounds of the 95% CI is less than 4.6 points difference on the K10 between groups) compared to participants who do not receive personal risk profile at the endpoint (4 weeks). ii) The participants provided with the current risk profile and achievable risk profile will have higher levels of psychological distress (defined as a significant difference in K10) compared to participants who do not receive personal risk profile at 1-week post-test. iii) The participants provided with the current risk profile and the achievable risk profile do not have significantly different levels of wellbeing (defined as a significant difference in SF-12) compared to participants who do not receive personal risk profile at the endpoint (4 weeks). Other hypotheses available on request.
Interventions
Brief name: MindTrack App Arm 1: Current personal risk profile; Arm 2: Achievable personal risk profile; Arm 3: (Control) No personal risk profile. The “Mindtrack App” is a software that is NOT being used as a medical device. The purpose of the App is to test different ways of communicating personal risk of future distress. The mode of delivery of the App is via a smartphone, on an individual basis. The Mindtrack App is a mood monitoring App adapted from the “Headgear App” (attention control version) developed by the same team for research purposes (UNSW HREC HC number: HC17021). The University of Sydney hosts the study site. The study is conducted on a smartphone App (Mindtrack), which is available to Apple and Android users in Australia for once-off free-of-charge download. Participants can download and use the App at a time and place convenient to them. The Mindtrack App will be removed from the Apple and Google Play stores after recruitment for the study is closed. The duration of the study is 6 months, with the trial running for 5 weeks. Following baseline assessment participants will be randomly allocated to receive one of 3 risk profiles once only. Following receipt of their allocated condition, all participants will be encouraged to continue engaging with the App for a period of 4 weeks by monitoring their mood once every week (by completing the primary outcome measure (K10) weekly). The application also automatically monitors and records usage and adherence outcomes on a continuous basis, to provide data on level of engagement with the App. At Week 4, participants complete the endpoint measures (K10, SF-12, and ASHQ) via an online wufoo survey. Participants will receive a maximum 3 SMS reminders with a unique link to complete the survey, spaced at least two days apart. At Week 5, participants “unlock” their Mental Fitness Report in the App. After the completion of the study, participants can continue to use the Mindtrack App for as long as they wish. They can remove the App by uninstalling it from their smartphone. The “Mindtrack” App is a mood monitoring App freely available from Apple Store and Google Play. It involves a 4-week challenge to help individuals understand their risk of developing mental health problems through an initial assessment and ongoing mood monitoring. The main features of the MindTrack App are a risk calculator, mood tracking, a weekly quiz (K10), and a Mental Fitness Report, as well as automatically generated weekly reminders and support service resources. Participants are randomised to a study arm after completing of the baseline measures in App. For those in the active arms, each participant receives a personalized risk profile for developing future distress, calculated using the published HILDA risk algorithm for future distress in working adults, based upon their self-report responses to baseline and risk items. This consists of “current” personal risk estimate of developing a common mental health problem within the next 12 months (Arm 1), and additional information of their lowest possible risk if in the “achievable” group (Arm 2). Materials and wording provided to each participant are as follows: Arm 1: Current personal mental health risk profile: Participants receive their personal risk estimate of developing a common mental health problem within the next 12 months. They are shown an icon array which displays the numerical risk estimate of that individual, along with a text description “XX out of 100 people with your risk factors are likely to become distressed within the next year”. Arm 2: Achievable personal mental health risk profile: Similar to the current risk profile condition, participants first receive their personal risk estimate of developing a common mental health problem within the next 12 months. They are shown an icon array which displays the calculated numerical risk estimate of that individual, along with a text description “XX out of 100 people with your risk factors are likely to become distressed within the next year”. They are then shown on the next screen their “achievable risk”, in which the icon array displays the lowest possible risk estimate for that individual, based on the targets being met for all the modifiable risk factors. The icon array is shown with the accompanying text “Many risk factors are changeable. You could lower your risk to XX out of 100 by improving your mental fitness. Participants will also see a list of their top modifiable risk factors.
Sponsors
Study design
Eligibility
Inclusion criteria
Eligibility criteria are: • Adult aged between 18 years and 70 years • An Australian resident • In employed work • Fluent in the English language • Has access to their own smartphone • Has a valid mobile phone number
Exclusion criteria
There are no a priori exclusion criteria.