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    Digital therapeutics and mental health apps, with Vaile Wright, PhD

    enJune 07, 2023

    Podcast Summary

    • Digital therapeutics: Software for mental health treatmentDigital therapeutics are personalized software programs that deliver evidence-based mental health treatments, using advanced technology to expand access to care, but require regulation, prescription, and payment like traditional therapies.

      Digital therapeutics are software programs designed to deliver evidence-based and validated psychological treatments for mental health disorders through digital platforms. They differ from other mental health and wellness apps as they aim to treat disorders like depression and anxiety, rather than just teaching coping skills. Digital therapeutics work by digitizing established treatments, such as Cognitive Behavioral Therapy (CBT), and using advanced technology like AI, machine learning, and natural language processing to personalize the treatment to the patient. These apps are not direct-to-consumer and require regulation, prescription, and payment similar to traditional therapies. While they show promise in expanding mental health care access, questions remain regarding their regulation, prescription, payment, and evidence base.

    • Digital Therapeutics for Personalized Mental Health TreatmentsDigital Therapeutics using AI, offer personalized mental health treatments, particularly for insomnia, with evidence-based interventions like CBT. Effective for various mental health conditions and physical health issues. Provider involvement enhances their effectiveness.

      Digital Therapeutics, which include AI-driven devices and applications, offer personalized mental health treatments, particularly for insomnia, using evidence-based interventions like CBT. These therapeutics have been approved for various mental health conditions such as substance use, anxiety, trauma, ADHD, and even physical health conditions like irritable bowel syndrome and pain disorders. The evidence shows they are effective, often as effective as in-person therapy, and can save time and resources. However, providers play a crucial role in determining appropriateness, setting up use, monitoring progress, and ensuring patients don't need higher-level care. These digital interventions can include chatbot features or avatars for real-time interaction and tailored treatment. A recent meta-analysis showed that provider involvement enhances their effectiveness.

    • Mental health chatbots: Convenient, flexible, and effective treatmentsMental health chatbots offer evidence-based treatments for mental health conditions, designed by experts, with flexible schedules and monitoring by providers. Regulated like medical devices, they expand prescription authority beyond MDs and psychologists.

      Mental health chatbots offer evidence-based treatments for various mental health conditions, designed by experts and delivered through convenient, flexible schedules from the comfort of one's own home. These platforms use scripts based on best-practice psychological treatments, allowing patients to progress at their own pace. Providers monitor patient progress through data and surveys, offering support through messaging features or scheduled calls. The FDA regulates these digital therapeutics similarly to medical devices, focusing on both efficacy and safety. The regulatory process involves demonstrating the product's effectiveness through research and ensuring its safety for use. Over-the-counter devices require no provider involvement, while others require a prescription from an appropriate healthcare professional, expanding the prescription authority beyond MDs or certified psychologists. Despite the regulatory process, there is ongoing confusion regarding the regulatory space due to the limited number of FDA pathways.

    • Digital therapeutics: Innovative solutions for mental health access and efficiencyDigital therapeutics offer innovative solutions to mental health access and efficiency in healthcare systems, with growing adoption by VA, Kaiser Permanente, and through employer contracts. They complement, not replace, in-person therapy and can help address long waitlists, limited access in rural areas, and patient preference.

      Digital therapeutics, which use psychological treatments within the scope of practice of various providers, are not the same as prescribing pharmaceuticals. While there is currently no universal way to reimburse digital therapeutics in the traditional healthcare system, they are being incorporated into offerings by systems like the VA and Kaiser Permanente, as well as through contracts between employers and device companies. Digital therapeutics are not expected to replace in-person therapy entirely, but they can be used to address issues such as long waitlists, limited access to care in rural areas, and patient preference. The mental health crisis requires innovative solutions, and digital therapeutics can be an important tool for providers to address access and efficiency in care.

    • Expanding Access to Care with Digital TherapeuticsProviders need education on digital therapeutics for wider adoption, regulatory and reimbursement paths are unclear, cost is a concern, and the APA is promoting greater understanding among consumers and providers.

      Digital therapeutics, which can address both mental and physical health needs, offer significant opportunities for expanding access to care. However, the lack of awareness among providers about these new tools is a major barrier to wider adoption. Providers need education on how to use and incorporate digital therapeutics into their practice, while companies creating these tools are still figuring out regulatory and reimbursement paths. The cost of these digital therapeutics can vary greatly, making affordability another concern. The American Psychological Association (APA) is working to address these challenges and promote greater understanding of digital therapeutics among both consumers and providers. It's crucial to view these tools as therapy supplements, rather than just another pharmaceutical product, and advocate for their inclusion in healthcare coverage and workflows.

    • Evaluate mental health apps carefully before useResearch effectiveness, look for mental health professionals, and check privacy policies before using mental health apps. Be cautious with wellness apps as they have no regulatory oversight.

      While mental health apps can offer convenience and accessibility, it's crucial for consumers to carefully evaluate them before use. These apps, especially those not classified as digital therapeutics, have varying levels of effectiveness and privacy policies. Consumers should look for published research studies, mental health professionals involved in design or advisory roles, and transparent privacy policies. Digital therapeutics, which diagnose, treat, or cure mental disorders, are subject to regulations like HIPAA and FDA approval, ensuring data protection. In contrast, wellness and lifestyle apps have no such oversight, potentially putting personal health information at risk. The American Psychological Association (APA) plays a role in informing consumers about what to look for in these apps and historically reviews them in its "Let's Get Technical" column. Always remember, it's essential to do thorough research before downloading and using mental health apps.

    • Distinguishing Digital Therapeutics from Wellness AppsTo advance digital therapeutics in mental health, it's crucial to clarify their distinction from wellness apps, ensuring proper regulation, reimbursement, and wider acceptance through education and evidence-based interventions.

      The field of digital therapeutics faces significant challenges in gaining understanding and acceptance due to being often confused with wellness apps. The lack of differentiation between the two hinders progress in regulation and reimbursement. Digital therapeutics, which use evidence-based interventions to treat various conditions, require a higher standard for demonstrating effectiveness and safety. By fostering a better understanding of their unique value, policymakers and stakeholders can make more informed decisions, ultimately leading to greater access and impact on mental health issues.

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