A randomised evaluation trial of the Life Flex digital health program for anxiety and depressive symptoms.

A transdiagnostic, cognitive behavioural and biopsychosocially-based digital health program, offered through the HealthZone platform, for adults with anxiety and depressive symptoms (called Life Flex), will be evaluated using a randomised control design. To gain access to the study, people are asked to create a ‘HealthZone’ platform (the Life Flex digital health program is one program amongst others that are housed within the HealthZone platform) account. This will involve providing an email address, username and strong password. Once the person has completed this, they will receive a confirmation email which they will need to verify before they can proceed any further. To remain anonymous, we suggest people use an email address that does not contain their first and last name. Once the person has created a HealthZone account, they can then re-enter the platform and sign up specifically for the Life Flex program. Here they will need to consent to participate in the Life Flex study, after reading through this Plain Language Information Statement. People who consent to participate will be given access to the Life Flex digital health program immediately following the pre-intervention assessment 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 was specifically designed for this study 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 8 weeks. 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 Flexibility: Looks at wellness and positive emotions 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 week to help gauge their progress. Modules include text, graphics, audio, video, editable forms, gif animations, interactive quizzes and games (e.g., brain training) and downloads. There is also an automated digital conversational agent (ALEX), whose goal is to try and increase motivation levels in those participants who are finding it difficult to complete any Life Flex module. Modules can be accessible via web, mobile or tablet devices. The Life Flex program is housed within the participant's ‘HealthZone’ dashboard. HealthZone is the parent platform that houses other 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, and My Profile. Participants will be asked to complete a pre-intervention assessment (Week 0), during intervention (Week 3, 5 & 7) assessments, post-intervention assessment (Week 9) and at a 3-month follow-up assessment (Week 21) 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 26. Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / strategies they visited / used and when), be asked to complete a weekly brief check-in survey asking them about module reading and offline activity progress, as well as reviewing the completion of daily mood and lifestyle event survey data and the scheduled intervention assessments. Participants may be invited to provide additional feedback about their digital connection experience after post-intervention assessment via telephone, video-chat or a messaging session (real-time).