Single Group Open-Label Hybrid Type 2 Effectiveness-Implementation Trial of a Third Wave Virtual Reality Treatment for Youth Depression and Anxiety

All participants in this trial will receive the VR intervention (i.e. single group trial). The VR intervention is adapted from third wave CBT protocols (including mindfulness and Acceptance and Commitment Therapy, or ACT) and focuses on decentering—the ability to step back and view thoughts and emotions as temporary, objective events rather than identifying with them. The VR intervention is designed for use in clinical settings and focuses on three core skills: • Arousal reduction through controlled breathing. • Sitting with uncomfortable thoughts and emotions without reacting. • Cognitive defusion from negative thoughts by changing how they are perceived. The intervention is delivered in-person, in a one-to-one format by a clinician with a young people, with five, 60 minute sessions over 10-12 weeks. Each session uses VR exercises to introduce and practice the skills described above, with the support of a clinician who will be in the room with the young person. The clinician cannot see what the young person is seeing however will be able to explain key concepts prior to entering the virtual environment, assist with VR use, and provide a debriefing after each exercise. • Session 1 introduces the concepts behind decentering and explores how stepping back from thoughts and emotions can reduce distress. The VR component helps young people visualize and interact with their thoughts in a new way. • Session 2 teaches arousal reduction through a controlled breathing exercise in VR, helping young people manage strong emotions. • Session 3 focuses on acceptance of uncomfortable emotions by allowing participants to sit with difficult thoughts in VR, learning that these emotions will pass if they don’t react to them. • Session 4 introduces cognitive defusion, where participants alter the physical representation of a negative thought in VR and engage in a game that reframes how they perceive the thought, making it less distressing. • Session 5 involves a review and reinforcement of learning and revisiting any activities that may be beneficial. Each session concludes with a discussion on how to apply the learned skills to real-life situations. This structured approach ensures that young people can easily integrate the skills into their daily lives. To record adherence to the protocol, clinicians will record whether the session was delivered according to the protocol in clinical notes. VR session use will also be recorded within the headset (time and date stamped). Implementation strategy: In addition to the VR intervention, an implementation strategy was developed to support implementation within routine youth mental health settings. Based on co-design sessions with clinicians, which explored anticipated barriers to using the VR intervention within mental health practice, we identified key barriers (e.g. clinician confidence with VR) to address with implementation support during the trial. With reference to the Expert Recommendations for Implementing Change, from this work, and conversations with participating services, the following implementation strategy was devised to support clinicians and services within the study. Training: Participating clinicians will receive in-person experiential training by an experienced VR therapist and researcher to deliver the VR intervention within sessions with young people. Training, and supporting materials, will be designed to increase clinicians' capability and confidence around technology, VR, and the five sessions of the VR intervention. Supervision: Participating clinicians will receive monthly, one-hour online supervision for VR-supported mental health care provision, in small groups, with an experienced clinical psychologist. Supervision supports challenges that may arise in the delivery of the VR intervention and any issues, questions, reflections that may arise from delivering care using technology. Technical support: Ongoing technological support will be available between 9 and 5pm to participating clinicians throughout the intervention period. VR developers with extensive experience in VR interventions and providing remote support to clinician and other stakeholders will be available to troubleshoot and enable the provision of the VR intervention. Facilitation: A locally based implementation facilitator will further support participating clinicians and their services to use the VR intervention through fortnightly calls or in-person drop ins (primary strategy to promote adherence). The facilitator is experienced supporting stakeholders to integrate digital tools in their clinical care and has established relationships with participating services. The facilitator will also be trained to support services with technical difficulties, should services encounter a problem that is unable to be supported by the remote technical support.