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Digital Mental Health Care
Looking Ahead: Systematic Changes Needed to Implement Digital Mental Health Care

Released: September 18, 2023

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Key Takeaways
  • Using technology to facilitate equitable access to evidence-based mental health care is a national priority supported by the 2023 White House Domestic Policy Council.
  • In digital medicine, usability is as important as efficacy. This principle is akin to pharmacotherapy: If patients do not take the pill, it will not treat the disorder.
  • The Access to Prescription Digital Therapeutics Act was designed to catalyze payers to establish a payment methodology for manufacturers of prescription digital therapeutics. Passing this bill will facilitate real discussion about implementation of apps as medicine for mental health and substance use disorders.

“The substantive costs of mental health disorders do not come from treating them, but rather from not treating them.”—Ana Catarino, Nature Mental Health 2023.

The need for mental health and substance use services has reached an unprecedented peak, and there is a pressing need for equitable access to all levels and types of behavioral care that is efficacious, timely, and sufficiently reimbursed by insurance providers. Our current mental health infrastructure was not designed to support the increases in demand that are being seen, leaving a large unmet need at the population level. A recent report confirmed that more than one half of adult patients (57%) who sought mental health and/or substance use care were unable to access services between January 2019 and April 2022. In response to this gap in mental health care, in February 2023, the first-ever White House Report on Mental Health Research Priorities was published. The White House Office of Science & Technology Policy partnered with the White House Domestic Policy Council to establish cross-agency scientific research priorities to improve how we prevent, diagnose, treat, and destigmatize mental health conditions. This document ranked “Understanding and leveraging digital mental health technologies” second out of 8 in terms of efficiently and equitably expanding services to suffering people. However, despite its potential, to date, few—if any—digitally delivered interventions have traversed the divide between lab and clinic. The gold standard evaluative evidence of “effectiveness” trials or real-world evidence is sparse, and many ingenious digital interventions fail before any public health impact can be realized. Below, we identify gaps in funding, research, implementation, policy, and infrastructure that must be addressed if digital mental health care is to join psychotropics and behavioral treatments as a viable third pillar of intervention in psychiatry. How do we rapidly scale up efficacious digital mental health care to meet the needs of this large and growing patient population?

Regulation of more traditional healthcare professionals (HCPs) and healthcare-associated devices is well established by statute, regulatory guidelines, and common law precedents. Applications (apps), by contrast, pose a novel regulatory challenge. The novel nature of apps, and specific-often-technical expertise needed to carefully evaluate them, poses a unique challenge for their scientific and peer review. Even very seasoned content and intervention experts may not necessarily have technical experience in designing/building and/or clinical experience in testing apps. In fact, in part because of the sizeable costs of developing and supporting usable apps, many scientists with this specific expertise are driven from academia and toward industry to more rapidly develop and disseminate their scientific ideas, consequently leaving a dearth of expertise in the academic setting that is “conflict free” or unaffiliated with a for-profit company. This is, of course, a surmountable challenge, as more rigorous clinical trial, neurobiologic, behavioral, and safety data become available for scientific review and as increases in funding supports development of digital interventions for mental health, not just a randomized controlled trial (RCT) once the majority of the development has occurred at the cost of the scientist.

Even with exponential growth of apps as treatment, some of which come from the most brilliant minds in mental health intervention research, few, if any, have been integrated into clinical practice. Currently, it is very unlikely that someone will visit a psychiatrist or psychologist and be prescribed an app. The data seem to support that innovation and initial efficacy alone are insufficient to result in adoption by stakeholders into real-world settings. High attrition rate in mental health app use is pervasive: Rates of engagement among the top 10 apps decreased by 43% from the initial to Week 2, and 22% from Week 2 to Week 6 on average. One potential explanation is a failure at the level of implementation and usability, and the likely culprit is the traditional RCT.

The RCT method was initially designed to evaluate fixed molecules and adapted to test manualized therapies. It is not well suited to the evaluation of a rapidly advancing technology. In practice, that means that an app must be tested “as is” in an RCT model, often spanning years, rendering some or most of its technology obsolete before any public health impact can be realized. By contrast, many commercial apps have biweekly “updates” improving features in a perpetual cycle to maintain and/or improve user engagement. A “fixed” app is unlikely to gain traction when compared with other rapidly advancing technology if it is not allowed to adapt to user expectations. In a collaboration between the University of Utah Health and the University of Connecticut Health, our group recently proposed alterations to the RCT gold standard to enable digital tools to advance with the cutting edge of rapidly advancing technology during a trial. The proposed format may have great potential to inform future interventions of this type and support mobile apps in “usual care” settings. Deploying digital mental health interventions outside of research settings requires careful consideration and systematic evaluation of not only clinical outcomes but also implementation and usability. (Usable apps are easy to learn, efficient to use, easy to remember, not prone to errors, and subjectively pleasing.)

Intervention science for mental illness is guided by neurobiology, and the motivation to alleviate the suffering of our patients. However, implementation of interventions relies on multiple stakeholders who can facilitate or block the app’s uptake in the real world. The healthcare system tends to adapt sluggishly to novel treatment paradigms—whether pharmacologic or digital. As use of apps as treatment is a novel model for HCPs, payers, hospital administrators, and regulatory agencies alike, our current system is bogged down by questions surrounding prescription app use: Who pays? And how much? Is it prescription? Who is responsible for the patients? How are “visits” charged if patients are remote? Does a licensed HCP have to “provide” the service?

Recently, Congress proposed the Access to Prescription Digital Therapeutics Act, which was designed to catalyze payers to establish a payment methodology for manufacturers of prescription digital therapeutics, product-specific Healthcare Common Procedure Coding System codes, and a digital therapeutics manufacturer reporting process to the Centers for Medicare and Medicaid Services. This legislation comes at a critical moment for patients and marks an important step toward expanded patient access to digital interventions for chronic and mental health conditions. Creating benefits and access pathways for Medicare- and Medicaid-covered populations will provide patients with remote access to therapies that can tremendously affect quality of life and healthcare outcomes, as well as reduce long wait times, reduce costs, and remove common barriers to empirically supported treatment.

Your Thoughts?
Equitable access to quality, insurance-accepted behavioral care is an ongoing challenge in mental health care. Apps as medicine have the potential to mitigate access issues, but systematic changes are needed before these apps become commonplace in clinical practice. Have you seen patients affected by access barriers to behavioral care in your clinical practice? Answer the poll and tell us more in the comments.

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Have you seen patients affected by access barriers to behavioral care in your clinical practice?

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