None listed
Conditions
Brief summary
This is a 12-week RCT trial involving a 6-week wellbeing program delivered via the app. The trial will recruit healthy adults from the app user base with the aim of measuring the participants’ levels of mental wellbeing over time and determining whether the app is effective at increasing their wellbeing, compared to an active control version of the app.
Interventions
This is a 12-week trial involving a 6-week intervention with 2 arms and 3 measurement occasions. The trial will recruit participants from the user base of the wellbeing app, and the aim will be to measure the participants’ levels of wellbeing over time and to determine whether the app is effective at increasing their wellbeing when used for a 6-week period. The wellbeing app was designed for this study. It is not yet readily available in the Apple Store, but will become available upon start of the clinical trial. After downloading the app and accepting the terms and conditions, new users will be given a choice between using the app as a regular subscriber or participating in the trial and using the app for free for the 12-week period. Those who choose to participate will be taken through the informed consent process and will answer screening questions to ensure eligibility. Consenting eligible participants will be enrolled in the trial and randomly allocated to one of the two arms (Intervention or Active Control). All participants will complete an online survey immediately before starting week 1 of the intervention (pre-test), a second online survey immediately after finishing week 6 of the intervention (post-test), and a third online survey 6 weeks after finishing the intervention (follow-up). All aspects of the trial (e.g., the consent form, screening questions, and surveys) will be administered via the app in an automated process. If the minimum sample size requirement is met, each arm will comprise at least 243 participants for a total sample size of 486. In the intervention arm, the participants will be instructed to use the wellbeing app for at least 10 minutes a day over the initial 6-week period. The app measures the users’ wellbeing profile and then provides a personalised range of psycho-educational readings and interactive activities suited to their profile to complete each week. Each week, a new set of activities are recommended until all the readings and activities are completed, after which the user will cycle through the resources again. The priority of activities are based on their wellbeing profile, with a new profile computed every 4 weeks. The activities are designed to be repeated regularly, so the user can cycle through the full set of resources again and again until the end of the study period. After using the app for 6 weeks, the intervention participants will be suggested to use the app for another 6 weeks if they wish to until the final survey is completed. At each of the three measurement occasions, the intervention participants will complete an online survey measuring their levels of mental wellbeing as well as other relevant variables including work performance, satisfaction with the app, and mood symptoms of depression, anxiety, and stress. The app will also record the user’s activity (e.g., how many minutes of usage per day, how many activities completed, etc.), allowing the researchers to measure treatment compliance.
Sponsors
Study design
Eligibility
Inclusion criteria
Aged 18 years or older Can understand written English Has no current moderate to severe mental illness symptoms Residing in Australia, New Zealand, the UK, Ireland, USA, or Canada
Exclusion criteria
N/A