The MobiliseMe study: Testing the effect of different smartphone activities on young people's mental health

This trial will examine the effectiveness of a new CBT smartphone application (ClearlyMe) for reducing depressive symptoms in in Australian adolescents (aged 12 to 17 years) when compared to guided use and an active-attention matched control condition. This study will utilise a three-arm randomised controlled trial. Participants will be randomly allocated to receive one of three interventions: a new mental health smartphone application called ClearlyMe (Trial Arm 1), or the ClearlyMe smartphone application) and a weekly SMS chat delivered by trained research staff (Trial Arm 2), or weekly SMS tips and information for their mental health (Trial Arm 3). The duration and schedule of the interventions will be the same for all participants; all being instructed to spend 20 minutes per week for six weeks completing their allocated activity on their smartphone. Trial Arm 1. Intervention 1 – Self-directed CBT smartphone application ClearlyMe: Participants allocated to this condition will receive ClearlyMe. ClearlyMe is a free, self-directed CBT-based smartphone application that provides therapeutic content and symptom management strategies to adolescents experiencing mild to moderate depressive and anxiety symptoms. The application was specifically designed for adolescents by a multidisciplinary team of psychologists, researchers, user experience designers and software developers at the Black Dog Institute. ClearlyMe is delivered as an autonomous, non-sequential CBT program consisting of 37 brief lessons (i.e., therapeutic content alongside activities). Lessons include the following evidence-based treatment components: psychoeducation, cognitive restructuring, emotion awareness and acceptance, goal setting, problem solving, activity scheduling, behavioural activation, exposure, relaxation, mindfulness, and values labelling. The lessons also encourage participants to practise the psychological skills in-between lessons and return to the app to reflect or access further content as needed. The lessons vary in length, taking between 5 to 10 minutes each to complete. To help navigate the program content, users are encouraged to complete the lessons via nine curated ‘collections’. A collection is defined as a structured selection of related lessons grouped together with a brief title and introduction. Each collection varies in length, taking approximately 20 minutes to complete. Users can also complete the individual lessons from a ‘show all’ list whereby they self-select lessons considered to be relevant to their individual needs. In this list, lessons are categorised into three groups depending on their target: ‘emotions’, ‘thoughts’, ‘behaviours’. The application also includes a Moodcheck (i.e., brief mood monitoring), Mind Hacks (i.e., quick strategies that help in the moment), and Stories (i.e., short videos of young peoples’ experience managing mental health symptoms and positive help-seeking experience) to provide users with additional pathways to accessing therapeutic content. For these features, specific lessons are recommended after the feature is accessed. ClearlyMe also includes in-application reminders, ‘saving’ and ‘favourite’ functions to support users to return to the application to reengage in content. In-application reminders include a ‘revisit the application’ reminder, which notifies all participants to use the application if they haven’t done so in the past 7 days. Users can also set an additional reminder to use the Moodcheck feature once a day for as many days as they wish. Due to the developer requirements of iOS and Google Play, smartphone application notifications must be able to be disabled in a user’s phone settings. The application also includes a ‘Get Help’ section that contains information of when and where to access additional mental health support services (e.g., Kid’s Helpline). To ensure compliance, participants who fail to download ClearlyMe within 7 days of randomisation will be sent an email and SMS reminder to download. Trial Arm 2. Intervention 2 – Guided use of CBT smartphone application ClearlyMe: Participants allocated to this condition will receive the same intervention provided in Trial Arm 1, with the addition of a weekly guided support session. This will take place in the form of a SMS chat provided by the research team for the duration of the intervention period. Participants will be contacted via SMS on their mobile phone number at the times provided to participants after randomisation (3:30pm to 6pm Monday to Friday). Contact will be made weekly, with one additional attempt made for non-response (within two days of the initial attempt). In total, participants in this condition will receive 6 weekly support sessions in the intervention period. Personnel conducting the guided sessions will be research employees of the Black Dog Institute and will use a standard script, with a decision flow chart to direct the chat. The SMS chat will consist primarily of technical support with some low intensity motivational coaching. Research staff will be trained to conduct these sessions and will be supervised by a clinician. The clinician will be available during these sessions to support the RA if needed. The guided support sessions will be designed to be conducted in one sitting (i.e., within 20 minutes) but duration and script compliance will be recorded by the research assistants. The interventions are not personalised, titrated, or adapted to individuals in any intervention arm. Participants in Trial Arms 1 and 2 are instructed to complete the application content by undertaking at least one collection per week (approximately 20 minutes) for the intervention period. The study will collect research data associated with their use of the intervention to assess participants’ adherence. This information will be used to determine which aspects of the intervention are important for improved outcomes. This trial will collect the following usage data from the ClearlyMe app to determine adherence: lessons completed, collections completed, features accessed, total time spent in app, content liked/disliked, content saved, and individual responses to lesson activities. Strategies to maintain intervention adherence will be implemented. For example, the ClearlyMe application (Trial Arms 1 and 2) includes automated reminders that prompt participants to use the application if they have not done so within 7 days. Those in Trial Arm 1 will also receive additional weekly SMS notifications regardless of their use of the application. Participants in Trial Arm 2 will receive guided supported (weekly SMS support sessions) to encourage engagement with and completion of ClearlyMe activities. In addition, participants in Trial Arms 1 and 2 who have failed to download the application within 7 days of completing the baseline assessment will also be sent a follow-up email and SMS reminding them to download the application.