The Future Proofing Study: A School-Based Depression Prevention Trial

The Future Proofing Study is a large school-based cluster randomised controlled trial testing whether depression can be prevented using a digital CBT apps in young people. Participating schools will be randomly allocated to one of two groups. One group will serve as the control group, and the other will be the intervention group and receive the SPARX CBT app. This trial will combine a universal prevention intervention (Stage I; SPARX) with an indicated prevention intervention (Stage II; Sleep Ninja). The interventions will be delivered in two stages spaced 12 months apart. Both interventions will be delivered to Year 8 school students via smartphone apps designed to work with iPhone and Android operating systems. Apps will be available to install for free from the Apple App and Google Play Stores in Australia. Stage I Intervention Name: SPARX SPARX is a gaming treatment intervention, which was developed by researchers at the University of Auckland. SPARX was adapted by the research team from the treatment version to focus on the prevention of depression in young people. The program is based on CBT and delivered via smartphone app. CBT is the gold standard psychological intervention for the prevention and treatment of depression and involves developing skills to help cope with difficult or challenging situations. Skills learnt though the program include relaxation skills, emotion identification and management, behavioural activation (being active), recognising and challenging unhelpful thoughts, and practical problem solving. This intervention is delivered in a game format, where users move through an imaginary world developing psychological skills. The gaming component allows the participant to choose an avatar and then undertake a number of skill-building challenges in the context of a fantasy world. This component is supplemented by direct instruction, education and activities (or homework) provided by a ‘guide’ avatar. SPARX consists of seven modules (levels) which cover: finding hope, being active, dealing with emotions, problem solving, recognising and challenging unhelpful thoughts and bringing it altogether. Each module takes approximately 20 minutes to complete. Each module is designed to be completed on separate days, and users are encouraged to do between one to two modules per week. SPARX will be accessible to all trial participants who are randomised to the intervention arm of the first stage of the trial. SPARX-FP will be installed onto participants’ own smartphones during a supervised classroom visit and completed at school during supervised classroom sessions and in their own time during the first 6 weeks of the trial. SPARX-FP will become active immediately following the baseline assessment. At the end of this 6-week period participants will lose access to the app. SPARX-FP will collect usage data while the app is active. This includes when and how many times users enter the app, how long they spend in the app, and how many modules they complete. It will be up to individuals how many modules they complete and whether or not they choose to finish the program. Stage II Intervention Name: Sleep Ninja Sleep Ninja will be delivered to a subset of participants from the Stage I intervention arm. Participants scoring equal to or greater than 10 on the PHQ-A at 12-month follow-up (indicating moderate depression, estimated at approximately 20% of sample) will receive an automated invitation to install the Sleep Ninja app onto their smartphones. Sleep Ninja is a smartphone app based on Cognitive Behaviour Therapy for Insomnia (CBT-I), which is the gold standard, evidence-based treatment for insomnia. Sleep Ninja was developed and tested for acceptability in Australia (Werner-Seidler et al, 2017) and covers the following skills and strategies: psychoeducation, stimulus control, sleep-focused cognitive therapy, basic sleep hygiene and behavioural activation. Sleep Ninja takes the form of a chat-bot. When the app is open, conversation messages appear on the phone screen from the Sleep Ninja (who acts as a sleep coach) and users interact with the Sleep Ninja by selecting from pre-determined responses, to which the Sleep Ninja is programmed to respond. Users progress through six levels or “belts”, starting at a white belt and working their way through to black belt status. To level up and gain the next belt, users must complete within a 7-day period: • one training session (which takes approximately 5-10 minutes); and • at least three nights of sleep tracking using the app’s sleep diary. At the completion of each level, users are provided with a brief report card summarising their self-reported sleep over that period. There are additional optional app features that users can access at their choosing, which include a meditation recording, extra sleep information, quick sleep tips and a ‘Get Help Now’ button that links directly to Australian crisis support services including Kids Helpline. If participants agree, the app sends a reminder each morning to enter sleep tracking from the night before, and a reminder an hour before bed to begin winding down in preparation for sleep. Sleep Ninja will be available only to participants who meet inclusion criteria for the second stage of the trial following the 12-month follow-up assessment and who are randomised to receive the sleep intervention. Eligible participants are required to complete this component of the study, having opted in during the initial consent stage. However, they have the ability to choose not to install the app on their phones if they don't want to. Participants will complete the intervention during their own time. Depending on the frequency of use, participants can take as little as 18 days to progress to black belt status, however, regardless of progress, all participants will lose access to the app 6 weeks following randomisation. It will be up to the participant to decide how much of the program they complete. Adherence to the Sleep Ninja app will be monitored by the app which records app usage and module completion.