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The “cab driver test” is a convenient metric of sentiment analysis to determine when a treatment or product has reached a hype cycle. For example, when your cab driver is advising you on experimental drug infusions or supplemental enemas, the information available to the public is probably beyond the purview of the specialists. For 

, the equivalent could be that when Gwyneth Paltrow produces a 

 episode on the subject, the space has slipped out of the control of academia and science and is significantly being directed by market forces. It is no longer a “field”—it is now an “industry.”

These forces that dictate the direction in which the industry will grow and mature have shifted beyond the organicity of academic cadence. A keen eye would note the significantly disproportionate development of the industry: Of the 73 biggest companies in the psychedelic industry that have taken in $3.26 billion in capital, $2.9 billion is in drug development.

 This is unsurprising considering the valuation multiples and revenue growth of pharmaceuticals compared with the other subsectors in the psychedelic ecosystem, including clinics, therapist training, and true academia.

Although most of the industry seems intent on developing novel and patentable psychedelic substances, a key factor that appears largely overlooked by the growth wave is, as one of the most prominent researchers in this field, Robin Carhart-Harris, PhD, titled his 2018 paper, “the essential importance of context.”

Context, more commonly described in the psychedelic field as “set and setting,” refers to the careful preparation of the patient mindset before and while they go into the psychedelic session, along with the physical setting in which the dosing takes place—the structure, music, decor, and other environmental components. However, that is but the obvious, floating tip of the contextual iceberg.

Context is a multifaceted, all-encompassing construct encapsulating treatment setting, therapeutic relationship, cultural milieu, historical inclinations, and social attitudes. Although therapist proficiency is key to therapeutic sessions and drug development modulates the experiential moments of the psychedelic session, context is the only factor that works to support both the psychedelic-based and the therapist-based components. The critical role it plays in treatment is far from unique to the psychedelic field.

If we consider the standard frontline pharmacological treatments for anxiety disorders, selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors, these drugs do not ameliorate mental illness via a single dose, nor does their continued use in isolation provide a “cure” for mental distress. Despite the many drug treatments that are available, many patients do not respond to initial treatment or even to sequential trials of differing medications.

According to an FDA meta-analysis of antidepressant effects from 15 years ago

“Drug-placebo differences in antidepressant efficacy increase as a function of baseline severity but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.”

In response to that, Christoph Hiemke, PhD, wrote

“Current knowledge indicates that effects of antidepressant pharmacotherapy are a sum of nonspecific effects, placebo effects, and pharmacological effects….It is proposed that 3-armed studies in which participants are assigned to either drug, placebo, or no treatment enable to measure exactly the differential effect sizes of drug and placebo. Such studies, however, do not exist so far.”

According to personal correspondence from Luke Downey, PhD, a professor and head of the Drugs and Driving Research Unit at the Centre for Human Psychopharmacology at Swinburne University of Technology in Melbourne, Australia:

“A host of reasons are implicated in the relative efficacy of these pharmaceutical treatments, and even in the cases where treatment is effective, these clinical improvements do not occur in isolation. The effects of these drugs when used in a supportive context are very important. They give patients the opportunity to benefit from other treatments and interventions including cognitive-behavioral therapy, mindfulness meditation, guided imagery with relaxation, solution-focused therapy, and coping skills and other education that address both symptoms of mental illness and triggers of distress. These nonpharmacological factors such as client-therapist relationship and the setting of any clinical intervention are considered key moderators of efficacy in psychiatry just as the developing field of psychedelic-assisted psychotherapy needs to consider modifiable components of this treatment.”

Is It Time for Psychedelic-Assisted Psychotherapy to Embrace Technology?

According to William A. Richards, “Those who have known these profoundly meaningful states of consciousness have often shared them with no one, or only with those most intimately trusted, for fear of being misunderstood, called 

 At the core of the psychedelic-based treatment is its capacity to tap into noncognitive, experiential, emotional, and embodied processes of healing, which are far more difficult to achieve with talk therapy.

In his recent thesis titled, “Integrating the Ineffable: A Social Phenomenological Analysis of the Psychedelic Experience,” Logan Neitzke-Spruill stated that, “The common understanding of the experience as ineffable may indicate a general lack of affirmative frameworks for integrating these experiences.”

In the words of Hamilton, one of the individuals who provided a narrative account of his experience with psychedelics, which were collected and published by Timothy Leary, “The experience is so fantastic in both its novelty and its power as to beggar all possibility of adequate depiction through words. The most that can be hoped for by way of description is an approximation, and only those who have had the drug can know how far removed from actuality the approximation must be.”

When we consider this in depth, the psychedelic experience appears to have more parallels with the virtual reality (VR) experience than with talk therapy. Both create an intimate, personal space for healing and introduce the patient to an alternate reality, and both experiences are characterized by ineffability. Utilizing those synergistic properties to explore and integrate the psychedelic experience allows more time for the emotional, embodied, experiential narrative to unfold, before it is analytically and logically processed. The psychedelic treatment model empowers patients to take responsibility for their own healing. The unique therapeutic process returns agency over one’s mental health to the individual.

 has always enabled distribution of power. It allows new perspectives on existing problems, often guiding our progress in ways we could not have expected. We develop tech, which, in turn, reshapes us. One of the powerful, robust tools that appears to be uniquely suited for contextual design that supports the intimate, patient-driven pathway of recovery—sometimes referred to as “the inner healing intelligence”—is VR.

At the University of Bristol, a team of computer scientists led by David R. Glowacki, PhD, concluded their study on immersive VR environments: “It is possible to design phenomenological experiences using multiperson VR, which create the conditions for mystical-type experience from which participants derive insight and meaning.”

The first-ever research study on combining VR with psychedelics was recently conducted by the authors in collaboration with Swinburne University of Technology and Psychedelic Society Belgium. Participants of this retreat-based study, which used psilocybin-containing truffles along with a bespoke anchoring VR designed by Enosis Therapeutics, reported that “VR brought me back to the feeling of something ineffable and a feeling of knowing,” and “VR soothed me before the talk integration process. It contributed to the sense of wonder and authenticity, and when you grab the stars, it feels beautiful.”

Those synergistic, state-altering properties can be easily taken advantage of in therapy. For example, VR expands the mode of self-expression beyond current analog means with immersive, 3-dimensional tools or personalized spatial designs of the VR model, which can be used to create representations of thoughts, insights, or emotions experienced during the psychedelic session. 

What is interesting and perhaps less obvious about this approach is that, while VR allows for a greater range of creative expression, the process of self-expression in a virtual environment also seems to challenge familiar modes of perception and activate a full-sensory engagement,

 reacquainting the patient to the experience of an altered state of consciousness. The intimate world of VR, which can be accessed without therapist interference, grants patients the unique opportunity of a space that can be used to explore and consolidate psychedelic experiences before they need to be verbally shared or discussed with another human being.

Technology leapfrogs many limitations of the analog system by offering an infinite number of levers with which to modulate the contextual design. This means that an entire range of possible solutions can be first thoroughly explored before settling on the best methodology. For example, in the current therapeutic model, patients transition from full visual range to having blindfolds on for the bulk of the psychedelic dosing session—an “all or nothing” model of stimuli exposure. 

VR allows for controlled dosing of stimuli, providing an entire spectrum of stimuli intensity, complexity, range, and duration. Just as important, it allows individual control over the stimuli that form setting design (via individualized VR environments), as well as the ability for rapid shifts in setting to correspond with volatility of the patient’s psychoemotional state.

According to Carhart-Harris, “Remarkably, despite its widespread adoption among psychedelic researchers, few controlled studies have ever been performed to test the assumed relationship between psychedelics and context.”

 Despite the apparent prioritization of “set and setting” in psychedelic research, the focus of innovation in the field is significantly skewed toward drug development while environmental and contextual factors are largely neglected.

In contrast to other medical fields, the human-technology interface is poorly explored in mental health care and almost entirely ignored in psychedelic care. A continued lack of dialog around the idea that technology could be a compatible resource rather than a competitive, counterproductive agent perpetuates the opportunity cost of the unmet potential of optimized healing environments in psychedelic treatment.

We believe that introducing technology allows an efficient and in-depth exploration of diverse contextual elements, which is of particular importance to a field that is only just beginning to take shape. This helps mitigate the risk of this paradigm-shifting approach to mental health treatment being shoehorned into incumbent psychotherapeutic models. A robust exploration and understanding of the altered-state experience should be the process driving the development of therapeutic frameworks that are designed around that experience—not the other way around.

is cofounder of Enosis Therapeutics and a PhD researcher at Swinburne University of Technology in Melbourne, Victoria, Australia. 

is cofounder of Enosis Therapeutics; founder of digital currency brokerage Caleb & Brown; and a clinical adviser to the Australian Psychedelic Society.

1. Psychedelic sector overview: opening remarks. Psychedelic Alpha. Accessed June 20, 2022. 

https://psychedelicalpha.com/psychedelic-sector-overview

2. Carhart-Harris RL, Roseman L, Haijen E, et al. 

Psychedelics and the essential importance of context

3. Kirsch I, Deacon BJ, Huedo-Medina TB, et al. 

Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration

Why do antidepressant therapies have such a poor success rate?

Sacred Knowledge: Psychedelics and Religious Experiences

Integrating the Ineffable: a Social Phenomenological Analysis of the Psychedelic Experience

. Master’s thesis. University of Delaware; 2019

7. Leary T. Timothy Leary: series IV. New York Public Library Digital Collections. Accessed June 20, 2022. 

https://digitalcollections.nypl.org/collections/timothy-leary-papers#/?tab=about

8. Glowacki DR, Wonnacott MD, Freire R, et al. Isness: using multi-person VR to design peak mystical-type experiences comparable to psychedelics. Paper presented at: ACM CHI Conference on Human Factors in Computing Systems; April 25-30, 2020; Honolulu, HI. Accessed July 11, 2022. 

https://research-information.bris.ac.uk/en/publications/isness-using-multi-person-vr-to-design-peak-mystical-type-experie

Virtual reality as a moderator of psychedelic-assisted psychotherapy

10. King JL, Kaimal G, Konopka L, et al. 

Practical applications of neuroscience-informed art therapy

How can a robust understanding of the altered-state experience drive the development of therapeutic frameworks that are designed around that experience?

Challenging the Status Quo of the Challenge to the Status Quo

COVID-19 has become a global pandemic affecting the lives of millions worldwide.

 Widespread outbreaks like COVID-19 have been found to be closely associated with symptoms of mental illness such as anxiousness, increased stress, feelings of hopelessness, and depressed mood.

In the elderly population, living under quarantine during previous disease outbreaks has led to increased incidences of depression, irritability, insomnia, and suicidal behavior.

 Adverse psychological sequelae of social isolation, which will be discussed in greater detail, have been shown to be correlated with female gender, toddler- and adolescent-aged children, higher-educational status, student status, and having symptoms resembling a COVID-19 infection.

 In elderly individuals, additional risk factors include having a negative perception of aging, health care-related occupations, abundant exposure to COVID-19-related information, knowing someone infected with COVID-19, and having a history of medical concerns.

Any given population under quarantine is more likely to experience heightened anxiety. Unwavering and occasionally sensationalized media coverage, sometimes perpetuating misinformation, may precipitate mass hysteria, stockpiling of supplies, xenophobia, and social unrest.

 Families unable to see loved ones in the hospital before their deaths are vulnerable to anger, resentment, and trauma.

 Rates of domestic violence have risen as more time is spent with those living in the same home.

Individuals who are predisposed to anxious tendencies may find that their anxiety manifests in the form of obsessive behaviors, such as increased temperature checks and more frequent sterilization.

 Patients previously treated for underlying psychiatric illness(es) may discontinue therapy and/or medications due to strict policies placed on health care access.

 In infected individuals, posttraumatic symptoms have been noted to develop during isolation, the severity of which correlated with the length of quarantine.

 It appears that virtually no demographic can escape the psychological pressure that quarantine imposes, resulting in various expressions of mental illness among the population as a whole.

In the setting of this public health crisis and subsequent mass psychological distress, society relies on health care professionals to support mental health. Abruptly increased patient volume can present new challenges for clinicians regarding their ability to meet these demands in a timely and effective manner. Because of the pandemic, telemedicine is being utilized more frequently to help provide better access to care.

 New technological advances have made it possible to provide a virtual platform for medical care that minimizes physical exposure.

To illustrate the challenges and opportunities for improvement in access to COVID-19-related mental health care, we present a case of a 58-year-old female who tested positive for COVID-19. Shortly thereafter, the patient developed symptoms of psychological and emotional distress, which necessitated mental health services.

History (Obtained During the Initial Psychiatry Assessment)

“Ms Harris” is a 58-year-old, single, Black-American woman with no significant psychiatric history. Ms Harris had been employed fulltime as a primary caregiver. She was referred to psychiatry for anxiety and concerns for possible depression. Ms Harris reported limited social support and no close relationships with family members.

Prior to her first appointment with psychiatry, the patient self-isolated at home for 3 weeks after testing positive for COVID-19. The patient agreed to a telephone visit, given the circumstances of an ongoing outbreak. During her initial psychiatric consult, Ms Harris endorsed feeling extremely “down and depressed,” noticing changes in her mood and behavior after learning of her positive test result. She said that she received no follow-up care from any health care provider since being in quarantine and isolation, and she described feeling as though she has been “abandoned and left alone.” Ms Harris speculated that “Maybe there is nothing they can do for me,” and disclosed severe feelings of anxiety regarding her health. Due to in-house quarantine measures, Ms Harris had not been working and was worried about being able to support herself financially. She stated that she had been living in fear, unsure if or when she would recover.

Ms Harris was diagnosed with adjustment disorder with anxiety and depression after a clinical psychiatric telephone interview. The patient was counseled regarding coping strategies and skills and provided with both online and telephone resources related to COVID-19. Ms Harris was scheduled for a follow-up telephone appointment with psychiatry 3 weeks after her initial consult, at which time she reported that her mood had improved and that she was less anxious about her health. Given her improvement, no medications were prescribed. Afterward, Ms Harris attended 2 subsequent appointments in which she demonstrated gradual improvement in her mental health. Ms Harris missed her fourth appointment and did not return the clinic’s calls thereafter.

In order to limit the spread of disease, quarantine and isolation procedures have been implemented during the COVID-19 pandemic. Quarantine was recently implemented during the 2003 SARS epidemic and the 2009 H1N1 epidemic.

 Studies of psychological symptoms during those periods found that being quarantined may be associated with a wide range of negative responses, including symptoms such as depressed mood, increased stress, irritability, insomnia, anger, fear, and emotional exhaustion.

 Other studies concerned with the long-term psychological sequelae of quarantine demonstrate that quarantined individuals may be at higher risk of posttraumatic stress disorder (PTSD) and depressive symptoms up to 3 years later.

 Literature on the current and prior quarantines have uncovered a plethora of risk factors for developing or exacerbating depression and anxiety, of which Ms Harris had several: female gender, advanced age, Black-American race, unemployment, recent health care occupation, single status, and lack of offspring.

Black Americans have been found to have higher rates of infections, unemployment, death, and anxiety related to the financial recession during the pandemic.19 Despite these experiences, in the same study, it was found that Black Americans had lower rates of anxiety and depression overall compared to non-Black Americans.

 Conversely, another study found that Black Americans experienced higher rates of anxiety and depression.

 Given the discrepancy between these 2 studies, it may be worthwhile to further investigate the psychological effect of the COVID-19 pandemic on Black Americans.

As previously discussed, health care workers are also at increased risk for adverse psychological outcomes during and after quarantine. Health care staff forced to isolate themselves at home may experience feelings of worthlessness.

 As a result of unrelenting exposure to acutely ill patients, those who continue as clinicians may experience apathy and withdrawal.

Relationship status is another notable demographic. Isolation for married couples can lead to increased anxiety due to a perceived imbalance in support, while nonmarried couples may struggle with increased jealousy.

 Moreover, single individuals have been shown to experience feelings of loneliness and depression.

Given the inordinate list of stressors that a population faces under quarantine, it is imperative that measures are taken to mitigate adverse mental health outcomes. Firstly, sleep difficulties are associated with suicidal behavior, so anyone with such a history should be evaluated for suicidal ideation.

 Furthermore, engagement in group activities and psychological interventions aimed at addressing maladaptive thought processes related to loneliness have demonstrated efficacy.

 In addition, elderly individuals may ameliorate the burden of the pandemic by strengthening social connections via virtual means (eg, group chat rooms, video chats), practicing good sleep hygiene, and engaging in cognitive stimulation.

An additional hurdle that individuals face during a pandemic is seeing a health care clinician in person, which causes many patients to participate in telemedicine. Telemedicine provided access to mental health services for Ms Harris while she quarantined and involved a phone interview with 2-way, real-time communication via audio only.

However, other telemedicine modalities are now being implemented as well. We are accustomed to some of these mediums (eg, electronic medical records, mobile phones, email, SMS text messaging, videoconferencing), while others have not yet been as widely incorporated (eg, patient portals, smartphone applications, social media). Clinicians seeking to utilize these modalities must be deliberate in determining the clinical function they serve while assessing the clinical impact that the modality may have on a particular patient.

The primary consideration should be that disinhibition between the patient and clinician can occur using any of these virtual platforms, the degree of which varies with the modality.

 As Jay Shore, MD, MPH, outlines in his evaluation of digital health care, virtual disinhibition may actually lead to the patient being more genuine about their experiences, although the modality itself may lead to more miscommunication.

Other constraints must be considered as well. Without video, clinicians are limited in their ability to observe nonverbal cues and perform physical exams.

 A sense of mutual connectedness and understanding between the patient and clinician may also be limited, as well as between physicians and their team.

 Studies have shown that phone-centered (as opposed to video-centered) telemedicine further decreases the ability to maintain positive therapeutic relationships, as facial expressions are perceived to facilitate communication.

 Even with video accessibility, it is a challenge to assess suicide risk, interpret body language, and provide appropriate therapy.

Some studies show that, with telemedicine, patients expect more frequent consultations, while others become less engaged.

 Patients often do not answer the phone when called, or they may conduct visits while they are at the grocery store, driving, at work, or otherwise distracted, which might greatly alter a psychiatric interview. During interactions, misunderstandings may arise from the use of abbreviations and emojis, or the possibility of a household member eavesdropping and/or otherwise influencing the patient’s report. The clinician should compensate for miscommunication by regularly asking if the patient’s message is being understood correctly. Ms Harris did not return for additional follow-ups after only a few telemedicine appointments, underscoring one of the major pitfalls of telemedicine: difficulty in building a therapeutic alliance

The preferred medium for telemedicine can vary according to the age of the patient and/or clinician. In a recent study, 75% of adults over 18 years old used phone-to-phone communication while individuals under 18 used video conferencing 50% of the time.

 Reductions in treatment success can occur when patients and/or clinicians use a telehealth format that they are not skilled with. However, in their study, Landes et al concluded that 48% of telemedicine challenges reported by clinicians were resolved over time after the clinicians became accustomed to the system.

 Early education on how to incorporate telemedicine into patient care could mitigate these challenges before they arise.

Although we are headed in the right direction in adapting to these difficult times, there are still concerns to be addressed and further investigated. Continued research should be conducted on the disparities in mental health, specifically related to the use of telemedicine, which relies heavily on digital devices and electronic tools. The best strategy to mitigate risks associated with digital care might be to have a combination of face-to-face appointments interspersed with telemedicine visits. In their study, Tse et al determined that 83% of patients would prefer a mix of the 2 services.

One possibility could be to mandate initial consultations as face-to-face, while additional follow-up visits could be performed either virtually or in person. Alternatively, physicians could implement a system in which a patient must have a certain number of in-person visits each year. Further research needs to be performed to assess which strategies would work best for patients. Discussion of the telehealth channel should occur with the patient prior to its use and continue after as the clinician and patient adapt to its impact.

The psychological consequences of living through a pandemic and being in quarantine are significant and should promote a sense of urgency to find ways to support the expansion of access to mental health care. Striving for improvement in the population’s access to care will not only help during this crisis, but also cause permanent changes in future health care delivery. As we continue to make innovative advancements in medicine, physicians must strive to be informed regarding the strengths and limitations of current practices and take into consideration the population being served to provide the best patient care.

 is a clinical assistant professor in the Department of Psychiatry at the University of Illinois College of Medicine in Chicago, Illinois. 

 is a member of the psychiatry residency faculty at Advocate Lutheran General Hospital in Park Ridge, Illinois. 

 is a fourth-year medical student at Rosalind Franklin University of Medicine and Science in North Chicago, Illinois.

Note: The views expressed in this paper are those of the authors and do not necessarily represent the official position or policy of institutions represented by the authors.

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Telepsychiatry in the Setting of COVID-19 and Beyond

 Scott, as a payer, how important is that evidence? Some prescription digital therapeutics are FDA authorized as a class 2 medical device. All of them are required to have clinical trials as part of the FDA authorization, yet there are many payers who are covering digital therapeutics that haven't gone through that approval process. From your vantage point, having assessed these technologies, how important is that FDA approval?

 It depends on the organization's commitment to the quality of its digital strategy. In my case, I interface with community-based health plans nationwide. It's important from a perspective of branding and credibility. It's okay to have something that may not fit the paradigm, but it can't be the only tool in your toolbox. The idea would be having all these different digital offerings. The table stakes of being in the digital strategy space is to have the credible tools for when you speak to your real audience, and your real audience are the larger stakeholders, the state you work within, the Medicaid system you work within. It's the health care systems that you're interfacing with, and their questions are always the same. Many times, it’s, “How does your digital strategy stack up to what is available out there?” Tim, your representation of the marketplace is entirely accurate. It's beyond chaotic out there. With something like FDA approval, I shorten that conversation. I brand the offering in a way that supports my brand, in a way that supports the providers who I'll be asking to adopt a strategy and the stakeholders who are reviewing the benefit design I'm building. It's absolutely essential. That doesn't mean you can't have others, but if you don't have the ones that are credible, the ones that really position you within your brand and your marketplace, you can't speak to the stakeholders you're speaking to in the way you would really like to.

 It's helpful to say that you're using the same evidentiary requirements, including FDA authorization, for a digital therapeutic as you would for a drug. These digital therapeutics are often an alternative to the drugs.

 If I could, I would just add that one of the most challenging conversations is when you sit down with a group of providers and explain to them what you're wanting to roll out. The realistic questions that they ask you is, “Explain to me, why this? Why not the other?” When you have a credible answer to that, it doesn't tarnish your credibility trying to ask them to do something that's meant to improve the patient population they're trying to serve.

 Authorization has been rigorously evidenced. To your point of doing cognitive behavioral therapy as an outpatient, most insurances, even Medicaid or Medicare, cover a certain number of cognitive behavioral therapies, or not even cognitive behavior therapy, just therapy sessions. That could be anything. We can go into a lot of therapies that aren't evidence-based that people are getting insurance coverage for. Why not apply that to something that's FDA authorized, with consistent algorithms and evidence in combination—in conjunction, if possible, or in lieu of?

 If we talk about examples, sleep, for instance. I have trouble sleeping. We know the FDA [does not look at wellness products] because of the 21st Century Cures Act. You can say this DTX [digital therapeutic] helps you out with sleep, and the FDA can say we won't look at that vs this product that helps with insomnia. Once you say that I'm going to treat depression, once you say, I'm going to treat insomnia, that's where the FDA clearance and everything else comes into play. Instead of going for your Ambien, they reach for that melatonin. You're going to have this split between a lot of digital therapies that are going to go under, not needing FDA clearance, because of what they're going to treat vs some of them having made medical claims on actual medical conditions, and the FDA is going to look at that. They're going to say you need to have evidence that this does that kind of thing. The question is, if you do that, does it need to be prescribed and become a PDT [prescription digital therapeutic]? Can it be something else? Nonetheless, once you’ve made that medical claim, that's a big differentiating factor right now in DTX.

Scott Whittle, MD, uses his knowledge and experiences as a payer—with the help of the other panelists—to explain how the FDA uses gathered evidence to make decisions on approvals for PDTs.

Using PDTs Evidence to Explain the FDA Approval Process

 Is it important to monitor patient use and response to therapy with the use of these tools?

 Many people from my pharmacist background, we see patients who are prescribed medications, therapy across so many conditions, but the reality is that I don't know if they take them half the time. There's different data out there, whether you want to look at medication possession ratio, but that just tells you that they paid for something, make claim on it. That isn't telling me someone adjusted therapy. For many of us having to talk to patients, we ask, “Did you take your medication?” How did they respond? More likely than not, patients will report negative outcomes, such as adverse events or average drug reactions compared with benefit. The benefit could take time in patients. For example, you put them on an SSRI [selective serotonin reuptake inhibitor], and they may respond, “It's been a week. Why don't I feel better yet?” You have to explain how it works. What's the mechanism of action vs DTX [digital therapeutics] and these PDTs [prescription digital therapeutics] are out there? Patients have this on their phone or through their medium that they can communicate through. They can see it and be like, “Okay, I'm doing these sessions. I'm giving feedback to this device and software, and I can see my action improvement.” They can see how they're responding to therapy, but they know that their provider's seeing that too. It's no longer going to wait 2 months to follow-up with my physician. You feel trust. Someone's seeing this and can see I'm doing better or not doing as good, and they can act on that. Personalization jumps out tremendously compared with traditional pharmaceutical medications. The issue is that data and how patients and clinicians have access to interpret it. It’s a changing paradigm of how we look at care overall.

 The patient and the provider are getting real-time or near real-time feedback. Anyone want to react to that?

 There's a lot of value added to it. I know of health care systems that have chosen to use a tiered approach, where they're comfortable writing the prescription because somebody shows up in the emergency department or in one of their receiving centers, and they know the engagement piece is complicated. They're willing to write that prescription upfront, watch the engagement, and then, maybe in a tiered way, manage that person through the health care system through using the dashboard if that individual needs an increased level of engagement. Ideally, we would always have that engagement piece with providers and with the patient themselves using the portal. Some health care systems are recognizing they don't have access to that kind of resource, and they're going to do the best they can with it.

 That's one area I've been critical of. We look at the market-shaping strategies across DTX right now; a large focus is on certain providers—eg, DOs [doctors of osteopathic medicine] NPs [nurse practitioners], PAs [physician’s assistants], etc—but the reality of the situation in digital health as a whole is that many providers don't have the time to sit back and look at that data. We know that's going to be dropped down onto ancillary staff underneath. My thought has been that we need to think about how we use involved nursing staff, pharmacists, therapists, and invest their time to take on some of that stuff because, to your point, how you triage—whether it's texting service through SMS or having a human coach come in—and then triaging that to the top level you want to go. Again, we're going to hit an issue of human scalability in the backend, that we don't have the time to look at all this data. Who's going to look at it? Who's going to intervene? Where do you want to intervene? At what level? I don't know of any provider that wants to be pinged on a Saturday night for minute kinds of things, but who should take that on? That's a conversation that should be explored further on. At some point, that comes back to the payers as well. If you want to make this work, you have to consider who's going to be touching this at the end of the day. There are prescribers up there, but the digital health and digital therapeutic spreads through the ecosystem, and you need everyone on board to make this function.

 I 100% agree, Tim. That's a valuable thing to think about and for payers to think about, reimbursement for time. I am on the Steering Committee for Psychiatry congress, a large conference. I've asked a lot of my psychiatry colleagues about digital therapeutics. I ask people's thoughts on it, and they’re scared to take on something else. First, they don't know enough about it, so they don't want to prescribe it, but then once they do know about it, the biggest barrier for the prescriber is the time commitment. At least on the ones that I've used frequently for opioid, alcoholism, and insomnia, the studies show that monitoring that dashboard by the clinician is actually part of what makes the digital therapeutics successful. Those that don't monitor it, it's not as successful without that key important piece. Who's going to spend the time doing it? For me, I have to have a little reminder during my administrative time twice a week to look at it, and then I send emails or texts or have my assistant do the same to patients, whether they're using it or not using it—giving them compliments on how excited I am about their improvement or how I'd really like them to get it started because then we have 20 days left on the prescription. I try and keep an engagement, and that's one piece of what makes it successful. We have to think about where that time commitment is going to come from.

Clinicians, pharmacists, and payers discuss how DTx and PDTs are monitored—for access, efficacy, adherence, and more.

Monitoring Patients Through DTx and PDTs

There has been a recent revolution in the development of digital health solutions for various chronic conditions. However, there are relatively few examples of digital health solutions that have been widely adopted in real-world health care settings and are measurably improving patient outcomes or helping health care systems deliver efficient and patient-centric care. From our vantage, there are some fundamental reasons for this “translational gap,” which, if addressed, can go a long way in helping realize the full potential of digital health technologies.

We use mental health/illness as an exemplar because brain-related illnesses will be at the forefront of digital health revolution, as their course can be monitored, outcomes can be measured via digital phenotyping, and interventions can be delivered digitally and remotely. Furthermore, the challenges and opportunities in digital mental health have been further highlighted by the ongoing COVID-19 pandemic, which has added fuel to an already brewing mental health crisis.

Mental Illnesses: The Need and the Opportunity

Mental illnesses represent some of the most prevalent and disabling conditions. Depressive disorders ranked number 4 in age group 10-24 and number 6 in age group 25-49 in the list of leading global causes of level 3 disability-adjusted life-years (DALYS)

 and are associated with a wide range of negative outcomes, including loss of occupational function,

 A key barrier to addressing these challenges stems from inadequate metrics to assess disease status, treatment effectiveness, and patient-relevant outcomes.

Mental illnesses do not have a clear outcome measure such as HbA1C in diabetes; instead, efficacy and outcome measures utilized in clinical practice today are complex and subjective, and are only sporadically collected or recorded in databases. As a result, assessment of quality of mental health care often defaults to the more easily measured process and structure metrics, which are distal from true patient outcomes, and, although they are easier to measure, improvement in these metrics does not always translate to improvement in patient-centric outcomes.

 This hampers outcome-relevant assessment of quality, which in turns hampers creation of value-based incentive structures that would lead to true patient-centric care and direct resources based toward the most impactful interventions (“pay for performance”).

The relative value of patient-generated digital data in driving measurement- and outcome-based care will be disproportionately high in mental health since brain-based disorders manifest with changes in behavior, cognition, and mood that are ripe for digital phenotyping. For example, recent and ongoing digital phenotyping efforts in patients with depression are demonstrating correlations between symptom severity and smartphone and wearable-derived features relevant to daily functioning such as physical activity and sleep as measured by actigraphy,

 sociability as measured by blue-tooth handshakes,

 and anxiety or stress as detected in speech features (natural language processing, or NLP) or physiological read-outs such as Galvanic Skin Response (GSR) and Heart Rate/Heart Rate Variability (HR/HRV). Such digital readouts can be more sensitive to real-time measures of symptom severity, functional impairment, and recovery status than episodic clinical assessments. These digital measures may also serve as proxy measures to assess value and efficacy of clinical care and interventions.

Of course, payers and clinicians will require that evidence for this be generated through long-term digital phenotyping studies that relate digital biomarkers with clinical milestones and cost. This will require long-term adherence to digital phenotyping solutions from the ultimate data source: the patient. Adoption and adherence have been challenges

 that can only be addressed if, regardless of the eventual utility for clinicians and payers, digital phenotyping solutions treat the patient as their first and foremost customer.

Using Patient-Generated Data and Digital Tech for Patient-Centric Care

Utilizing digital health technologies and patient-generated data for enabling outcome-based care hinges on developing a “data partnership” with the patient that is built on principles of trust, mutual benefit, and informed data access and use. This will become more urgent as advances in wearable technology and mobile health provide patients greater control over, access to, and use of their personalized health data. In fact, eventually the boundary between health care data primarily housed in electronic health records (EHRs) and so-called patient-generated health data will blur as agency shifts to the patient and we realize that all data—whether in EHRs or generated by wearable devices—is ultimately patient-generated, and thus, is patient owned and controlled.

Matters of privacy, transparent consenting, and, more broadly, trust are clearly “table stakes” for patient participation in a digital data collection regime. Beyond that, in our experience, conducting long-term multimodal digital phenotyping studies in patients with mental illnesses, 3 factors are most important for patient acceptance, engagement, and long-term adherence. First, any sustained digital phenotyping data collection, in the context of research studies or clinical care, must provide immediate “here and now” value and utility back to the patient, over the friction and burden it creates. This equation can be helped by relying on passive data collection and developing bandwidth-frugal applications with minimal impact on smartphone battery life and other factors important to patients.

Furthermore, the end-user interface and visualizations must be engaging and useful to patients.

 Designing such a solution requires a systematic data-driven understanding of patients’ attitudes, motivations, and barriers toward data collection.

 It is important to follow the common tech industry practice of co-designing solutions in close partnership with end-customers (patients), with iterative learn and improve cycles. We may find ourselves surprised at how often the end-users’/patients’ views on which features are important to them diverge from experts’ preconceived notions.

Second, altruism remains a significant motivator; most patients diagnosed with a serious condition are willing—even eager—for their data to be utilized in research that helps their fellow patients, assuming privacy and security safeguards. This propensity to be part of citizen-science efforts should be leveraged to develop “learning engines” wherein pooled, deidentified digital phenotyping data can be used to solve important problems of broad utility and impact.

Finally, we see physicians’ use of patient-generated data to improve clinical care as crucial motivator for patients to adhere to a digital data regime. In fact, this is perhaps the single most important criterion for patients with serious mental illness who are under the care of a clinician. From the physician’s perspective, the data and visualizations should make the clinic visit more efficient and should integrate readily with their current workflows. Such a system will also improve outcomes by improving patient engagement and enabling more measurement-based care,

 We believe digital health solutions that enhance the patient-physician interface and generate near-term value for both may require more effort for initial uptake, but are most likely to stick than direct-to-patient approaches often utilized by insurance companies and digital health solution providers.

Considering challenges and opportunities in digital health solutions for mental health care.

Digital Therapeutics

Challenging the Status Quo of the Challenge to the Status Quo

Telepsychiatry in the Setting of COVID-19 and Beyond

Using PDTs Evidence to Explain the FDA Approval Process

Monitoring Patients Through DTx and PDTs

Digital Health as an Enabler for Patient-Centric, Outcome-Based Care

Leading the Artificial Intelligence Revolution

Challenges with mHealth Apps for Depression and Suicide Prevention

Treating Depression and Preventing Suicide: The Impact of mHealth Apps

mHealth Apps for Depression: Overcoming Challenges

Need Your Sleep: DTx for Treating Comorbid Insomnia and Psychiatric Disorders