A randomised controlled trial of the effect of an m-health app and digital engagement strategy on treatment adherence and suicidal ideation.

The intervention being trialled in this study is called LifeBuoy. LifeBuoy is a mobile treatment app developed by researchers at the Black Dog Institute. It is a fully automated, self-guided program theoretically grounded in Dialectical Behaviour Therapy (DBT) and Acceptance and Commitment Therapy (ACT). The app was initially developed using co-design approach, with young people with a lived experience of suicide, via online surveys and focus groups. The first version of LifeBuoy was evaluated in a trial (ACTRN12619001671156), which commenced recruitment in March 2020 and completed data collection in September 2020. Preliminary findings demonstrated that it did lead to greater reductions in the severity of suicidal ideation in the intervention group, relative to the control group, at post-intervention – and these gains were maintained at 3-month follow up. The version of Lifebuoy being tested in this current trial has undergone further refinements based on qualitative feedback from trial participants, and in partnership with a youth Lived Experience advisory panel, recruited specifically for this purpose. The app contains seven learning modules and incorporates wise mind principles (distress tolerance, emotion regulation/mindfulness, interpersonal effectiveness) through interactive learning exercises to help young people develop strategies and problem-solving skills for managing suicide thoughts. Each module (island) is described in more detail below: Island 1: This module is focused on psychoeducation. It educates the reasons why people have suicidal thoughts. It highlights the association between dissociation and suicide thoughts and harms, and helps users to recognise common signs of dissociation. Finally, it teaches grounding techniques that users can engage in when experiencing suicidal thoughts, distress, or dissociation. The therapeutic goal of this module is to teach self-compassion via education, validation, and normalisation. Island 2: This module is focused on breathing techniques. It raises awareness of the importance of calm breathing, especially in situations when one is feeling stressed or anxious. It contains breathing tips and interactive practice exercises. The therapeutic goal of this module is relaxation and lowering baseline anxiety via education and interactive practice. Island 3: This module teaches users a wide range of distress management skills. The therapeutic goal of this module is to learn effective distress management via lowering physiological arousal and practicing soothing activities. Island 4: This module contains three mindfulness-based exercises aimed at helping users to a) observe physical sensations of an emotion without judgement, b) let-go of thoughts and difficult emotions, and c) anchor into the present moment. Mindfulness practice will help users to disengage or free themselves from automatic and unhelpful ways of thinking more quickly. The therapeutic goal of this module is improved cognitive presence and focus (and less emotional intensity) via mindfulness training. Island 5: This module educates users about their personal wellbeing contributors vs drains, help simplify and balance their life, and determine where best to focus their energy to prevent worry. The therapeutic goal of this module is holistic; to increase self-care, self-knowledge, and autonomy via reflective activities, self-protective activities, and building a locus of control. Island 6: This module introduces users to the basics of how emotions work and why they are important. It allows the user to explore emotional responses and learn and cognitive strategies for regulating emotions. The therapeutic goal of this module is improved emotion regulation via education, awareness practice, and cognitive restructuring. Island 7: This module helps users define what’s important to them, to make considered decisions, and align themselves with what is meaningful to them. It provides practical suggestions on how they may invest effort into the areas of their life that they hope to derive greater satisfaction from. The therapeutic goal of this module is greater self-knowledge and increased agency via meaningful goal setting and decision making. Safety: The Lifebuoy app also includes certain safety features on the main landing page which users are encouraged to access when in distress. The ‘Help’ button brings up a list of services that users can get in touch with for support, and allows them to create a unique safety-plan for suicidal crisis, which they can share with others (such as their family, doctor, or mental health professional). The ‘Toolbox’ button provides users easy access to some distress management tools, access additional information, and distraction strategies. The app also includes a ‘check-in’ feature that auto-appears when a user accesses the app for the first time each day or is accessible through the home screen. The check-in asks users how they are feeling today and if they select a negative mood, they are directed toward their safety plan, crisis contact numbers, and calming/distracting activities. Participants will download the LifeBuoy app from the App Store or Google Play onto their personal smartphones. Once the app is downloaded, it will not require internet connection; internet connectivity will only be required to upload usage and adherence data to UNSW servers. Participants will have access to the app - to complete seven modules - until the end of the 4-month trial period. Each module will take approximately between five to ten minutes to complete. The user will be directed to each module linearly and unlocking a new module will require completion of the previous one (this also is the gamification of the app, as island ‘light up’ or become technicolour when complete). Once modules are unlocked, participants can re-access them at any time. In addition to the LifeBuoy app, this study is seeking to trial a multicomponent digital engagement strategy aimed at increasing compliance with the LifeBuoy app. The engagement strategy will be comprised of 3 core components: 1. An Instagram account that will deliver brief, visual content that aligns to the strategies and educational information within the app itself. 2. A clinician-written and Lived Experience-written blog that will provide a platform to deliver in-depth therapeutic information and advice for maintaining mental health, and 'real-life' experience of living with mental illness/suicidal thoughts from a Lived Experience perspective, respectively. The amount of content in each blog article will be a 3 to 5-minute read, between 300-600 words. 3. Emails: weekly emails will be sent to participants with links to strategies 1 and 2, to remind them to visit them and in addition, the emails will suggest to participants what module within the app they might like to visit/explore that week and strategies for getting the most out of it. These emails will also include a 2-item survey, asking 1) "Have you visited the Instagram page this week?" (yes/no) and 2) "Have you visited the blog site this week?" (yes/no). We will track engagement in the strategies (Instagram and Blog articles) by counting the number of ‘followers’ on the Instagram account, and summing the 2-item survey which asks if participants have visited the Instagram and blog page this week. A subset of 40 participants from the LifeBuoy (n=20) and LifeBuoy + Engagement (n=20) arms will be asked to attend semi-structured interviews about their experience with the app and engagement strategies, at the 30-day post baseline time point. Participants will be selected on a first-in first-served basis. Interviews will be conducted separately by two members of the research team via video-conference. There will be a clinical psychologist on standby should the participant require clinical support. Interviews are estimated to take 45 minutes in duration, and will take place within 30-days of the assessment point. The decision to leverage these specific platforms was derived from a bottom-up approach, where we have spent almost 18 months gathering information and perspectives from young people with a lived experience of suicide. The sources of data include: qualitative interview feedback from participants in the first LifeBuoy trial (HC190764); (ii) data from a broad online survey of 260 mental health app users in Australia (HC200616) (iii) and input from a youth lived experience project advisory group (HC210038). The content and design for the Instagram and blog posts is being developed in consultation with the youth lived experience project advisory group, all of whom were participants in the first LifeBuoy trial. To deliver on the engagement strategy, Instagram posts will be uploaded at least twice a week throughout the duration of the study, up till 30 days after recruitment of the final study participant. The Instagram account will be public, with comments disabled, as public access allows users to view content anonymously (otherwise they will need to register to view the account, which may be perceived as a barrier to engagement). For the blog, new articles will be posted once a week throughout the duration of the study, again, up to 30 days following the recruitment of the final participant.