A randomised evaluation trial of the LIFE FLeX digital health and wellbeing program for anxiety and depression.

A transdiagnostic, cognitive behavioural and biopsychosocially-based digital health program, offered through the My Digital Health platform, for decreasing symptoms of anxiety and depression (called LIFE FLeX), will be evaluated using a randomised control design. People who consent to participate will be given access to the LIFE FLeX digital health program immediately but will be randomly allocated to one of two groups: 1) LIFE FLeX digital program A (immediate access to all of the program modules) or; 2) LIFE FLeX program B (weekly, sequential release of the program modules). LIFE FLeX is designed to provide people with information and strategies to address their anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module delivered over 7 weeks. There will also be a short two page ‘Booster’ module three weeks following the post-intervention assessment. The booster module will release at that time and participants will be notified by email that it has been released. The six core LIFE FLeX digital health program modules are: 1. Increasing Biological Flexibility: Looks at the biology of the stress response, understanding what biological flexibility is and what techniques to use to increase biological flexibility (e.g., increasing physical activity, breathing control). 2. Increasing Emotional Flexibility: Looks at what emotions are, increasing emotional awareness, and use of emotional regulation strategies. 3. Increasing Thinking Flexibility: Looks at the role of thoughts in depression and anxiety and how to increase thinking flexibility (e.g., identifying and challenging unhelpful thoughts). 4. Increasing Behavioural Flexibility: Looks at how what we do influences how we think and feel and how to increase behavioural flexibility through reducing avoidance through gradual exposure (for anxiety) and increasing activity through behavioural activation (for depression). 5. Increasing Wellness (positive affect) Flexibility: Looks at wellness and positive affect and how to increase wellness through various strategies (e.g., acts of kindness, openness to experience, social connectedness). 6. Increasing Life FLeX-ability: Recap’s the entire program, reflects over progress and discusses relapse prevention. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 20-30 minutes of offline activities each week. Offline activities include applying the concepts / techniques discussed in the modules such as self-monitoring depressive and anxiety symptoms, undertaking one of the increasing biological and wellness flexibility intervention strategies, monitoring emotions and thoughts and undertaking the gradual exposure or behavioural activation activity. Participants will also receive automated emails (e.g., to remind them to log on, when to complete ‘during’, post/follow-up intervention questionnaires) and will be asked several questions at the beginning of each module to help gauge their progress. Modules include text, graphics, audio, video, editable forms, interactive games (e.g., brain training) and downloads. Modules can be accessible via web, mobile or tablet devices. The LIFE FLeX program is housed within the participant's ‘My Digital Health’ dashboard. My Digital Health is the parent platform that houses a variety of digital health programs. Via the participant’s dashboard, they are able to access several resources. This includes: My Dashboard, My Inbox, My Daily Monitoring, My Progress Graphs, My Timeline, My Profile and My Tutorial. It also includes a ‘Connect to Practitioner’ request button. If clicked, an Australian-based participant can request that we add their healthcare practitioner to their My Digital Health account. If the healthcare practitioner consents to participate, the healthcare practitioner is then digitally connected to the participant’s My Digital Health account. Participants will be asked to complete a pre-intervention assessment (Week 0), during intervention (Week 3 and Week 5) assessments, post-intervention assessment (Week 8) and a 1- and 3-month follow-up assessment (Week 12 & Week 20 respectively) and they will be able to access the LIFE FLeX program for the entire trial period. However, while the ‘during’, post-intervention and follow up assessments are scheduled, participants will not be able to access the program until they have completed the scheduled assessments (or after the expiry time to complete the scheduled assessment has lapsed). Participants will retain access to the program until Week 27. Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / strategies they visited / used and when), as well as reviewing the completion of daily mood and lifestyle event survey data and the scheduled intervention assessments. Participating healthcare practitioners may be invited to provide feedback about their digital connection experience.