Virtual Intelligence for Transformative Lifestyle Solutions in Pain

Opioid misuse and opioid use disorder (OM/OUD) constitute a persistent public health emergency that is projected to escalate. In 2018, about 2 million individuals in the US had an OM/OUD, associated with a high mortality rate of approximately 130 daily deaths, comorbid psychiatric disorders, and other poor health outcomes. Further interventions are needed to reduce the impact of opioid misuse, OM/OUD, and overdose. Chronic pain affects over 100 million individuals in the United States, and opioids prescribed to treat pain can increase risks of misuse, physiological dependence, and OM/OUD. Research indicates that 64.4% of OM/OUD patients report chronic pain, which can trigger relapse, reduce adherence to OM/OUD treatment, and diminish quality of life. Standard care for OM/OUD includes medication, such as methadone maintenance therapy (MMT), and psychosocial treatment. Given the adverse effects of chronic pain among patients with OM/OUD, there is an unmet need for complementary approaches to assist OM/OUD patients with pain.

In patients with OM/OUD and Chronic pain, psychosocial treatment is provided using a variety of approaches, one of which is Cognitive behavioral therapy (CBT). CBT is an evidence-based treatment that has been shown to be effective in managing both chronic pain and OM/OUD by helping patients develop coping strategies and alter maladaptive thought patterns. However, traditional CBT faces challenges such as limited accessibility due to geographic, socioeconomic, and psychological barriers, and high dropout rates due to its repetitive nature. Studies show patient-reported barriers to use of non-pharmacological treatments in chronic pain included high cost, transportation problems and low motivation, while top-ranked facilitators included availability of a wider array of options and a team-based approach that included follow-up. For this reason, more readily available and accessible options are needed.

VR technology offers an innovative treatment paradigm for patients with OM/OUD and chronic pain. A recent study showed that a VR meditative intervention can modulate pain and modify neurobiological markers in patients with OM/OUD. The immersive environment can significantly enhance patient engagement, making sessions more interactive and enjoyable, while providing pain relief. Furthermore, by providing a captivating virtual experience, VR-based psychosocial check ins can improve retention rates and ensure patients complete their therapeutic programs.

A significant innovation of VR-based biopsychosocial check-ins is its potential to make psychosocial interventions more accessible and tailored to individual needs. Traditional face-to-face CBT can be inaccessible due to geographic, socioeconomic, and psychological barriers. VR can overcome these barriers by providing a flexible treatment option within the clinical setting. Moreover, VR environments can be customized to accommodate patients with varying literacy levels, using visual aids and interactive elements to ensure comprehension and engagement, particularly for those with a third-grade reading level. VR provides an experiential learning platform where patients can practice biopsychosocial skills in a controlled, simulated environment. This method allows for repeated practice of coping strategies and pain management techniques, which is crucial for skill acquisition and generalization to real-world settings. The ability to engage in realistic scenarios within VR can enhance the transfer of these skills to daily life, improving patients' ability to manage pain and opioid cravings outside the clinical setting.

Few studies have previously utilized VR and AI to deliver conversational biopsychosocial check ins and lifestyle education specifically targeting the combined treatment of chronic pain and OM/OUD. There are limited studies on the efficacy of AI tools in mental health. Mental Health America has an AI-powered tool which allows users to type their negative thoughts, and the program assists them in reframing the thoughts. This novel application not only addresses the limitations of traditional CBT but also explores the potential of VR and AI as a versatile and effective medium for treating co-occurring conditions. The integration of VR and AI represents a promising approach that could significantly enhance therapeutic outcomes for patients with these complex conditions. The AI virtual coach is designed to provide a non-judgmental, empathetic, and supportive environment. By interacting with an AI coach, patients may feel more comfortable discussing sensitive issues without fear of judgment or bias, which can reduce internalized stigma and encourage openness. Additionally, some patients find it easier to disclose information to AI-based avatars. AI systems can enhance patient support by providing adaptive treatment recommendations based on patient feedback, effectively supporting patients and optimizing healthcare resources. Moreover, AI allows the adaptivity of the difficulty level to the demographic specificity of the patient, ensuring a more personalized and effective treatment approach. Research has shown that interactive and immersive environments can significantly enhance user engagement, leading to better adherence to treatment protocols. To promote equitable access to our VR intervention, the investigator team anticipates expanding its availability for in-home use in future phases and larger studies as part of the research. By developing portable and user-friendly VR systems, the study team aims to overcome barriers such as transportation difficulties and limited access to clinical facilities, particularly for underserved populations. This approach aligns with research indicating that home-based VR interventions can effectively reach diverse patient populations and improve accessibility to care.

The VR software has been determined to be non-significant risk by the Institutional Review Board (IRB) based on the 21st Century Cures Act. Section 520(o)(1) of the Food Drug and Cosmetic (FD\&C) Act specifically excludes certain software functions from medical device classification.

• Efficacy - Change in Pain Severity [Time frame: From pre- to post-VR session, up to 3 hours]
• Efficacy - Change in Avoidance Behavior [Time frame: From pre- to post-VR session, up to 3 hours]
• Efficacy - Change in Anxiety [Time frame: From pre- to post-VR session, up to 3 hours]
• Efficacy - Change in Mood/Depression [Time frame: From pre- to post-VR session, up to 3 hours]
• Efficacy - Change in Mood [Time frame: From pre- to post-VR session, up to 3 hours]
• Efficacy - Change in Mindfulness [Time frame: From pre- to post-VR session, up to 3 hours]
• Efficacy - Self-efficacy in managing Drug/Opioid use and cravings [Time frame: From pre- to post-VR session, up to 3 hours]
• Safety - Virtual Reality Sickness Questionnaire (VRSQ) [Time frame: Up to 1 hour following completion of ~ 45-minute VR session]