After nearly a century, digital therapeutics have now hit an inflection point where novel and effective therapeutic software is experiencing explosive and exponential growth that will scale across the global healthcare industry. To appreciate where we are today, it is helpful to see where we have come over the past century. Applying the Innovation Lifecycle model, this article breaks down the past 100 years of progress in information technology and behavioral psychology into three 30 year phases—Discovery, Incubation, and Acceleration— and explores where and how digital therapeutics will expand in its current phase, Scale.

As with all human innovation, there has to be the serendipitous co-evolution of many different areas of science for a technology to scale. In each phase of cognitive behavior therapy (CBT) evolution, there has been a concurrent technological development that enabled behavioral scientists to invent innovative ways to apply computer technology to deliver CBT. This evolution of delivery facilitated progress toward automating safe and effective ways to deliver this novel therapy to address, manage, and treat problems like stress, anxiety, and depression. 

We are now at the point where most of us have super computers in our pockets with the ability to deliver attractive, stimulating, AI-driven user interfaces and activities. High quality digital therapeutics have been shown to be as effective for certain conditions as current gold-standard interventions. Digital therapeutics based on CBT have increased access to high quality treatment in a global shortage of therapists, which is particularly important in the context of a pandemic.

The Innovation Lifecycle for CBT and Computer Technology

The Innovation Lifecycle, as applied here, was published in Tension: The Energy of Innovation (2014) to describe the four phases of the innovation process. Each phase is focused on moving the innovation forward through various types of development and experimentation to de-risk its adoption and to reach the next phase, where the ultimate goal is to successfully scale the innovation to the mass market.

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Discovery (1930-1960)

The first wave of behavioral therapy can be traced back to the behaviorist movement that began in the early 20th century with key figures including John Watson and B.F. Skinner. This was a radical departure from Freudian psychoanalysis, which emphasized the role of the unconscious. Based on principles of operant learning and classical conditioning, behavioral Interventions would instead be focused directly on problematic behaviors that were exhibited by an individual rather than what was happening in their mind.

Simultaneously, World War II drove the acceleration of computing to break Nazi codes using the Turing Machine invented at Bletchley Park in England. This success then led several American companies to develop and commercialize computers in the 1950s, such as the Sperry Rand UNIVAC, the most successful mainframe computer of the era, the IBM System/360 that combined hardware, software, and service in a novel business model that came to dominate the mainframe age. 

Incubation (1960-1990) 

Aaron Beck and Albert Ellis formed the foundations of what we know as CBT today in the 1960s. Beck is considered by many as the father of CBT, and his 2019 article on its history gives great insight into how his theories and consequently his therapeutic techniques were developed. 

By outlining the maladaptive thought processes (beliefs that are false and rationally unsupported) that underpinned a condition like major depressive disorder, he could construct a therapy specific to that particular condition and develop scales alongside the treatment, like the Beck Depression Inventory (BDI), to quantify the severity of each condition. We have so much to thank Beck for, and his theories still underpin the cognitive techniques that are used today. HAP_053_Therapy_Article_Graphic_02

 

As conditioning theory fell out of favor and the cognitive revolution gathered speed, computers underwent three decades of radical transformation. Intel was established in 1968 and revolutionized computing with its microchips, DRAM, and microprocessing. At the same time, HP and IBM led the development of floppy disk drives. These and other innovations ushered in two successive waves of computing paradigms. 

First there was the minicomputer, which decreased the footprint for computing from an entire room to something the size of a small car and replaced the mainframe. Then in the 1970s, the microcomputer burst onto the scene, decreasing the size by another order of magnitude to the size of a large typewriter and thereby replacing the minicomputer. In each successive wave, the computers exponentially declined in size and costs while increasing computing power and capabilities exponentially. Like Apple and Microsoft, these new entrants disrupted incumbents and became the market leaders in the microcomputing age.

The earliest iterations of computer therapy software (Selmi et al, 1990; Colby & Colby, 1990) were designed to replace therapists. These early programs relied solely on text communication, required patients to be computer literate, and the process required long periods of concentration—clearly not a formula for mass adoption. Communication between the patient and computer that was often stilted, demonstrating the difficulties of replicating natural language and the therapeutic process. Early computers were also painfully slow at these tasks, and despite their decline in price, were still way too expensive for this type of therapeutic application. 

Despite these issues, studies from as early as the 1970s demonstrated patient acceptance of computer therapy programs, their willingness to share sensitive information with a “robot,” and most shocking of all, that some patients preferred speaking to the “robot” rather than a clinician (Greist, Klein, & VanCura, 1973; Lucas et al.,1977). These developments enabled a higher fidelity proof of concept that suggested that eventually computer therapy could become mainstream once the technology was small enough, fast enough, intuitive, smart, easy to use, cheap, and ubiquitous. 

What’s more, authors like L.G. Space recognized the merits of computers in the field of psychiatry and psychology, not to replace clinicians but to provide services to support them—for example, to conduct and interpret psychological tests and create comprehensive patient reports by integrating data from various sources. As costs of computer systems plummeted, costs for therapy increased, and the advantages of using computers to provide some mental health services became more apparent, and began to emerge as a real possibility.

Acceleration (1990-2020)

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While the earliest digital interventions were smoking cessation behavioral tools in the 1990s, interactive CBT software programs like Beating the Blues and MoodGYM started to appear in the early 2000s. Moving on from purely text-based software, cCBT in the 2000s was presented in a multimedia format. This helped to better engage patients, teach core methods of standard cognitive therapy, and reinforce learning. Self-help exercises became interactive and visually appealing with the addition of video, audio, and graphics. Interactive and engaging interventions could now be delivered in full in the patient’s home with only a small amount of supervision from a trained healthcare professional, and not necessarily a psychologist. 

Access to the internet also began to increase dramatically in this period, helping increase access to care and create greater flexibility for patients as content became available in a web format, giving rise to the term internet-based cognitive behavioral therapy (iCBT). It is also noteworthy that in the early 2000s, CBT gained popularity as an intervention not only for depression and other mental health concerns but also as an effective tool for people living with chronic disease. Research confirmed that some chronic disease symptoms, like pain, could be better managed by addressing the way people thought about, interacted with, and contextualized their experience of their illness.

As computerized CBT became more widely accepted as an effective therapy (a prime example of widespread adoption is the IAPT scheme in the UK), and smartphones started to appear (the iPhone was launched in 2007), the possibilities for digital mental healthcare delivery expanded even further. The nature of delivering CBT and teaching mindfulness via the ubiquitous smartphone (85% of U.S. adults now own one, compared to 35% in 2011) has enabled the supercomputer in your pocket now to possess the powers of an effective digital coach, capable of delivering therapeutic interventions. This new realm of specialized technological care can combat one of the biggest barriers to high-quality treatment: access, as we have profound global shortages of therapists to deliver CBT in person (or even in a tele-format).

Further, during this phase of the Innovation Lifecycle, some forms of CBT moved away from syndromes and towards core processes, as discussed in this 2017 article by Steven C. Hayes and Stefan G. Hofmann. The focus during this phase was on the individual's relationship to their thoughts and emotions, rather than on the content. Today, the scope of interventions now includes therapeutic approaches such as Mindfulness-Based Cognitive Therapy (MBCT), Dialectical Behavioral Therapy (DBT), and Acceptance and Commitment Therapy (ACT). This expansion in treatment approaches facilitated a wider selection of tools adaptable to digital delivery.  

The newest phase of iCBT delivery includes Digital Therapeutics (DTx), which are defined as “medical interventions delivered directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.”

Given the structured, skills-based nature of CBT, it is an ideal match for this mode of delivery. Further, traditional structure of CBT includes homework assignments that encourage the participant to try out their newly learned skills in the world and continuously practice honing over time. Rather than a one-size-fits-all approach, digital-based homework can be hyper-personalized to each individual.

There has been an explosion in funding and solutions coming to market in digital mental health over the last decade, and digital therapeutics, including prescription digital therapeutics (PDTs), have made a noticeable splash. While early offerings such as the original Happify product tended to focus on coping with stress and worry while increasing resilience, products have begun addressing increasingly more complex problems. For example, Pear Therapeutics had the first PDTs to receive market authorization for reSET (substance use disorder), reSET-O (opioid use disorder), and Somryst (chronic insomnia), while others tackled Irritable Bowel Syndrome (Parallel by Mahana Therapeutics), and Attention Deficit Hyperactivity Disorder (ADHD; EndeavorRx by Akili). Others, such as Happify Health, have been pushing the envelope by creating transdiagnostic PDTs like Ensemble to treat symptoms of more than one disorder at the same time (Ensemble is currently being studied and has not yet been evaluated by the FDA).

Translating a structured treatment manual to digital delivery seems like a simple task at first pass, and indeed many early (and current) DTxs essentially deliver a self-help treatment manual via an app. This approach to delivering treatment solved a problem (access) but it created a new puzzle to be solved: engagement. It quickly became apparent that patients are not interested in or motivated to read large blocks of didactic text, even if they recognize that they can stand to benefit from such tasks. Think about it: how many of us forgo a myriad of healthy habits that we know we ought to adopt but simply don’t for various reasons? 

During this phase, an entirely new science of digital engagement was born and perfected by social media companies like Facebook, video game companies like Epic Games, and digital commerce giants like Amazon to deliver gaming mechanics and use gaming principles and behavioral economics to get users highly engaged in these digital experiences. They led the way in how digital therapeutics should think about engaging experiences and how to apply the science of engagement to improve mental and physical health outcomes. Common buzzwords in this space include activation, retention, gamification, etc., but the heart of the matter is that DTx developers and researchers are working hard to understand how to get people to use—and continue using—digital therapeutics.HAP_053_Therapy_Article_Graphic_05_V1

Happify Health is an industry leader in this arena, as the two co-founders have an extensive background in technology and developing highly-engaging video games. They have found that not all the tips and tricks applied in other digital domains can and should apply in digital therapeutics, but most do translate to this new field and can be used to deliver levels of sustained engagement comparable to other digital products. The very premise of Happify Health was that tremendous health benefits could be realized if gaming mechanics and principles are used to deliver intervention activities based upon positive psychology, cognitive behavioral therapy (CBT), and mindfulness. Game principles and mechanics include things like incentives, points, rewards, levels, length and difficulty, narratives, flow, constraints, loss aversion, etc. Happify Health uses over 50 different game mechanics in its digital therapies.

Another option for increasing engagement with digitally delivered behavioral interventions is the use of a digital coach. A digital coach built with Artificial Intelligence (AI) and Natural Language Processing (NLP) capabilities can serve many purposes such as facilitating activities via a dialogue exchange, breaking down complex tasks into sub-tasks, tailoring interventions to the individual by integrating information the user has provided, and providing additional context or information to help the user apply a new skill or knowledge to their specific set of circumstances. A common assumption is that people are disinterested in working with a digital agent, but research has demonstrated otherwise, with some populations reporting experiencing reduced stigma and embarrassment and thus willing to disclose symptoms and experiences.

Similarly, reviews and analyses have demonstrated that digitally delivered CBT can be just as effective as in-person CBT and is often preferred by patients for a myriad of reasons that are interconnected to themes discussed earlier. Telehealth may have solved some problems of accessibility (e.g., transportation issues, some dependent care challenges), but others remain: limited providers, limited appointment availability, attempting to participate in psychotherapy with a 2-year-old vying for one’s attention, privacy to complete sessions, etc. 

But an important point here is that digital therapeutics need not be a mutually exclusive proposition. Digital therapeutics are poised to deliver a minimum floor of evidence-based care. They empower the patient to be active in self-care therapy for many hours without a clinician, thus enabling clinical leverage, where the patient is completing digital therapy for perhaps five to ten hours for every one hour they spend with a therapist in person. In addition, through digital therapy, providers could have access to regularly administered assessments, monitor intervention progress, and offer troubleshooting or elaboration on particularly challenging skills or concepts. 

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Scaling - 2020 to the Present 

As we enter this final phase of the Innovation Lifecycle, most people around the world have a supercomputer in their pocket that delivers many hours of engaging digital experiences from banking, shopping, music, movies, books, social media, games, and more. Much of this is wonderful, but much of it also creates mental, emotional and even physical harm. It is now time to harness this technology to intelligently heal our minds and bodies. 

We can now develop and deliver hyper-personalized therapeutic media through an AI coach, on regulated, safe, and secure digital platforms.  We can now apply the learnings of other digital technology leaders to digital therapy, and thereby make digital therapy as engaging as other digital experiences (like Netflix, Amazon, Facebook and others), with ubiquitous access to care, meeting high standards of quality and efficacy, and at affordable prices. 

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Given the profound shortage of mental health providers that is only getting worse, digital therapy can help solve the mental and physical health problems of our age. According to the National Alliance on Mental Illness, 1 in 5 U.S. adults experience mental illness; however, it is currently estimated that less than half actually receive treatment. One of the factors that is contributing to this treatment gap is the severe shortage of mental health professionals. More than 60% of U.S. counties (and 80% of counties in rural areas) have no practicing psychiatrists; and as rates of depression and anxiety soared during the COVID-19 pandemic, 30% of psychologists surveyed by the APA reported that they could not meet the demand for treatment.

Even before the pandemic, patients were having to wait over three weeks on average to see a psychiatrist, with some waiting more than 90 days before receiving care. Alongside digital therapeutics, there has been a proliferation of telemedicine/teletherapy companies that provide services on a 1:1 basis (sometimes referred to as “FaceTiming with a doctor”). While these services certainly improve access, they are still constrained by provider availability and thus will not be able to solve the demand for services.

The pandemic has made things significantly worse. The Senate Committee on Health, Education, Labor and Pensions and the House House Ways and Means Committee both held hearings on the current mental health crisis in early 2022. Soaring rates of depression, anxiety, and sharply rising overdose deaths have prompted a reexamination of inequities in care access. The federal government has deduced that over one-third of Americans live in a mental health professional shortage area and increasing the workforce alone is not enough to close treatment gaps. 

Despite the promise of access to care for all that DTx and other digital products can offer, there are still barriers to virtual care that need to be tackled. With any type of mental healthcare, reimbursement is one of the most prevalent issues; 42% of Americans see cost and poor insurance coverage as the top barriers for accessing mental health care (link) and the recent mental health crisis hearings referenced above made clear that mental health and substance use treatment parity laws are not being enforced. Looking at technology-specific barriers, 25 million Americans in low-income households still lack a high-speed internet connection, which is such a critical factor in receiving high-quality virtual care. Finally, from a cultural perspective, CBT has been in a state of evolution since its inception, and it is important that as it continues to evolve, it adapts to meet the cultural needs of a wider variety of individuals. Taking into consideration the patient experience across cultural groups from the earliest stage of digital therapy development can ensure that the end product will treat everyone who uses it as effectively as possible.

In addition to the profound need for mental health care that is not being met, iCBT can offer other benefits that are starting to be explored, in particular the positive effects on physical health (as mentioned above). Research evidence is now accumulating to support the connection between mental and physical health, not only to demonstrate how one can affect the other, but also showing the effectiveness of interventions like CBT and MBSR in the management of symptoms of chronic conditions including irritable bowel syndrome, diabetes (link), and cancer

Cognitive Behavioral Therapy has become one of the most commonly used behavioral interventions across the world, likely in part due to its ability to be rigorously studied and its benefits objectively measured. Several studies have also shown that CBT is, on average, just as  effective as medication (and in some cases more effective) in treating depressive and anxiety disorders and has longer lasting effects on people’s health. 

Advancements in technology have now accelerated this evolution as CBT and mindfulness to deliver these effective therapies at scale. Researchers and developers are delivering more clinical evidence of safety and efficacy of digital therapies at an astonishing rate; this growing evidence will continue to strengthen the position that digital therapeutics are a robust and viable approach.

 

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