LIFE FLeX: An Adaptive Treatment Randomised Controlled Trial for Reducing Anxiety and Depression for Adults.

A self-help, transdiagnostic digital mental health treatment program for reducing symptoms of anxiety and depression (called LIFE FLeX) delivered through the My Digital Health Platform will be evaluated in an adaptive randomised control design. Participants who consent and meet the study criteria will be given access to the LIFE FLeX digital health program immediately, however will be monitored for symptom improvement between two to three weeks post trial commencement. If a participant is not making progress (i.e., no change in anxiety and depression symptoms) they will be offered to augment their program with a therapist and randomly assigned to one of two treatment conditions Arm One; meet weekly with a therapist online via video-chat technology for up to 10 minutes or Arm Two; meet weekly with a therapist online via video-chat for up to 50 minutes. Video-chat support duration will be dependent upon the stage of module completion at which the participant is allocated a therapist. The maximum duration of therapist support delivered by video-chat will be up to 7 weeks. The LIFE FLeX program 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 8 weeks (participants are provided two weeks to complete module 4). 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 of the LIFE FLeX program will take approximately 25 minutes to complete. In order to reinforce the module-based information, there are 20-30 minutes of offline activities each week, which include applying the concepts / techniques discussed such as self-monitoring 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 and 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. Provisionally registered psychologists with Australian Health Practitioner Regulation Agency (AHPRA) who are in their 5th and 6th year of training within psychology will deliver the intervention in the two therapist assisted conditions. The therapists of the study delivering the intervention will receive a training package on diagnostic assessment (the MINI), semi-structured interviewing techniques, digital mental health interventions; specifically ethical and legal aspects of service provision for the use of video-chat technology to deliver treatment. The therapists of the study will be required to complete a mixture of online modules and workshops to ensure knowledge and competency with all therapists required to pass competency checks prior to commencing interaction with participants. Arm 1: Minimal support condition (supportive role)- Therapist support will be delivered weekly via video-chat technology, for up 10 minutes. The role of the therapist in the ‘minimal’ support treatment condition is to support the participant’s engagement with the LIFE FLeX program by specifically checking on participant progress with modules, participant understanding of program material, provide clarification where required and ensure that participants are clear on their between session module tasks assigned for completion. It will be important to ensure that fidelity of therapists’ role is maintained, that is, the therapists of the study remain in their ‘supporter’ role and do not to drift into therapy mode. Arm 2: High support condition (therapist role) - Treatment will be delivered weekly via video-chat technology, for up to 50 minutes. The role of the therapist in the ‘high’ support treatment condition is to deliver the content of the transdiagnostic program LIFE FLeX to participants in the role of therapist and then to redirect participants to the online program LIFE FLeX for revision and consolidation of material in between scheduled sessions. In order to ensure treatment fidelity and standardised treatment, the therapists will be provided with treatment manuals with random spot checks of their recorded video-chat sessions reviewed by two independent raters to determine adherence to study protocol. The provisional psychologists will receive regular opportunities for individual and group supervision from a registered clinical psychologist and AHPRA registered supervisor where any remedial strategies to improve fidelity will be implemented. Remedial strategies will include the provision of constructive feedback, a review of the components of treatment in sequence, further practice of skills where drift may have occurred, additional training (if necessary), review of initial fidelity training materials, and extra coaching/ supervision. Several semi-structured interview schedules designed to assess attrition, participant and therapist experiences of receiving and delivering treatment via video-chat technology, along with assisting implementation efforts post -trial have also been created for the study. The interview schedules are estimated to take approximately 10-15 minutes and will be offered to participants via telephone, instant messaging or video-chat.