Hybrid Type 2 Implementation-Effectiveness Trial of a Third Wave Virtual Reality Treatment for Youth Depression/Anxiety

Youth mental ill-health is a global crisis. One in five young people experience a mental health disorder every year, and suicide is a leading cause of death in this age group. In addition to costing the global economy $1 trillion per year in lost productivity, mental ill-health can have a severe and long-lasting impact on the lives of young people. Despite this, only a small proportion receive access to care, and of those that do, most fail to fully recover.

Technology has the potential to overcome many systemic barriers to accessing quality, sustainable care and importantly provide treatments tailored to young people's needs. In particular, virtual reality (VR) treatments have potential to tackle key limitations in youth mental health care. Through a VR headset, young people are transported into virtual environments that can provide powerful therapeutic experiences, enabling them to learn and practice skills to overcome mental health symptoms within personally relevant situations, under the safe and controlled supervision of a clinician. As a highly novel and interactive digital medium, VR has capacity to address barriers to help seeking and poor engagement amongst young people by delivering treatments that are fun, interesting and memorable. Meta analyses of randomised controlled trials have clearly supported the efficacy of VR treatments for improving mental health outcomes, however there are currently no available evidence-based options for youth and no studies have examined how VR treatments can be implemented in real world settings. This is a clear gap, with research demonstrating there is interest and need amongst clinicians and young people for innovative digital tools like VR to improve clinical care.

Through co-design with young people with lived experience and clinicians, a new VR treatment has been developed for youth depression and anxiety. Depression and anxiety are core transdiagnostic symptoms prominent in mood and anxiety disorders, which represent the most prevalent and debilitating mental health conditions with the highest burden of disease in youth populations. This new VR treatment is a blended clinical support tool which harnesses immersive VR environments to deliver targeted evidence-based treatment for depression and anxiety. Through engaging, interactive exercises, young people are guided to learn and practice core psychological skills based on ACT, an evidence-based treatment for youth depression and anxiety. Clinicians can use the third wave VR intervention within therapy sessions to help young people learn and practice these core skills in an engaging way, providing opportunities to improve treatment engagement, reduce drop out, and deliver a more effective learning experience that can translate into greater improvements in depression and anxiety in the real world.

Previous studies by our group included interviews with 30 young people and 10 clinicians which highlighted the perceived value of the third wave VR treatment for supporting clinical treatment by improving engagement and supporting therapeutic learning. An early experimental study \[under review\] with 20 young people found that a single session of MIND could improve negative mood states, with 100% of the sample preferring it to traditional therapy methods. As a next phase in this research, the current project aims to conduct a hybrid type 2 effectiveness-implementation trial to establish proof-of-concept evidence that the MIND intervention can be used to treat youth depression and anxiety within a routine youth mental health service setting. This trial design enables the simultaneous testing of implementation and effectiveness outcomes, thus accelerating the research to translation pipeline by seeking to understand how interventions can be implemented in real world settings.

The aims of this single-arm hybrid effectiveness-implementation pilot study are to:

1. Assess the feasibility of the study protocol, including recruitment, retention, trial-related adverse events, and assessment completion. 2. Evaluate the feasibility and acceptability of implementing the MIND intervention within routine youth mental health care settings, with a focus on intervention delivery, fidelity to the intervention model, and satisfaction levels among both participants and clinicians. 3. Identify barriers and facilitators to implementing the MIND intervention in routine care settings, including implementation indicators relating to staff training, resource availability for delivery, organisational support, clinician perceptions, and logistical barriers and facilitators. 4. Explore the preliminary effectiveness and safety of the MIND intervention by assessing changes over time in clinical outcomes, including measures of depression, anxiety, intervention mechanisms, quality of life, and intervention-related adverse events.

• Adverse events [Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)]
• Feasibility - attendance rates of assessments and sessions [Time frame: 12 weeks post intervention commencement]
• Feasibility - VR utilisation [Time frame: 12 weeks post intervention commencement]
• Feasibility - intervention implementation [Time frame: 12 weeks post intervention commencement]
• Acceptability - intervention satisfaction [Time frame: 12 weeks post intervention commencement]
• Acceptability - therapeutic alliance [Time frame: 12 weeks post intervention commencement]
• Acceptability - cybersickness within headset [Time frame: Within each intervention session]
• Acceptability - VR presence [Time frame: Within each intervention session]
• Implementation - adoption [Time frame: 12 weeks post intervention commencement]
• Implementation - fidelity [Time frame: Measured during monthly meetings with services, during training sessions (immediately following clinician recruitment), monthly supervision sessions, and each time a support ticket is logged]
• Effectiveness - emotional distress [Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up)]
• Effectiveness - severity of repetitive negative thinking [Time frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (followup)]