By Joel Morse, CEO & Co-Founder
Curavit Clinical Research
May 2024 marks the 75th anniversary of National Mental Health Awareness month. Mental health issues affect as many as one in four Americans and more people die from suicide in the U.S. than from traffic accidents or homicides. For every person suffering, too, there are dozens of loved ones who are painfully entwined in the endless struggles innately part of mental illness.
Since the inaugural awareness celebration in 1949, however, we have seen progress with a reduced stigma around mental health issues both at home and at work. According to a 2022 national poll by the American Psychiatric Association (APA), less than one-third (31%) of respondents say they are worried about retaliation at work for seeking time off for care compared to 43% in 2021 and 2020.
Even despite the decreasing stigmatism, we still have very few treatments. Nearly 60 million of the adults and children who have mental health conditions in the U.S. go without any treatment. Not only do people who seek treatment have to navigate a fragmented and costly system of obstacles, but in many cases, there is also no proven treatment available.
One of the problems is the complex nature of mental health. It is as varied and nuanced as people themselves, making it challenging for scientists to land on reliable treatments. There are many fluctuating underlying causes – some chemical, some environmental, and many a combination, making each person’s disease as unique as a fingerprint. How can a single pill treat all cases effectively? It can’t.
These seemingly insurmountable challenges also effectively serve to dissuade the commercial industry from even conducting the research. We need to strike a better balance between long-term and shorter-term payouts by committing more resources to mental health research. Historically, large pharmaceutical companies shy away from serious mental illness to other therapeutic areas where well-defined disease biology, biomarkers, and drug targets make R&D less risky, more attractive.
Fortunately, smaller biotechnology companies and startups are filling in the gap with digital health innovations that can overcome some of the common hurdles to treatment. And, more recently, some big pharmaceutical companies are dipping their toes in digital treatment research. For instance, in January, Otsuka announced the first FDA approval of a digital treatment for depression, co-developed with digital therapeutics company Click Therapeutics. Called Rejoyn, the smartphone-based treatment is intended for use by prescription, alongside antidepressants and cognitive-behavioral therapy.
Enter: Digital Pathways to Treatment
Curavit is a virtual contract research organization founded in 2019 and since our founding we have seen a dramatic increase in interest from a growing category of therapies called digital therapeutics (DTx) and – more broadly – digital health products. Much of the growth in this area has been in response to the mental health epidemic in this country, drawing heightened attention during the COVID-19 pandemic, largely because digital health products help overcome two of the biggest obstacles to mental health treatment: cost and access.
While digital health products can take various forms – from device to software – the majority take the form of an application. As such, they are much less expensive and easily accessible via mobile device, smartphone, or laptop. Patients don’t need to wait six months to get an appointment with their preferred therapist, rather, they can simply download the app and log in as needed.
One example is the Sana Device, a wearable, virtual-reality-style mask that uses audiovisual stimulation to reduce symptoms of post-traumatic stress disorder (PTSD). It aims to offer anxiety relief on-demand and allow patients suffering from PTSD to gain additional relief while on waiting lists for specialty care.
Another example is Swing Therapeutics’ digital therapeutic for chronic pain management (from fibromyalgia). Fibromyalgia is a chronic and debilitating pain condition characterized by widespread musculoskeletal pain often accompanied by fatigue, sleep, memory, and mood disruptions. Swing developed its application to provide an accessible behavioral therapy option that can be used alongside medication, physical therapy, and other standard-of-care treatments.
Of course, there are still significant hurdles to overcome for these treatments to become more mainstream and be seamlessly integrated into treatment regimens (these products are often used in combination with other therapies but can be standalone, too). All stakeholders need to be educated on their value and usage; patients included. Healthcare providers also need to spend time learning more about these innovative alternative treatments to earn their trust. Maybe most of all, payers need to be convinced of their value to be covered for most insured.
Based on our pipeline and hundreds of conversations that I have had with industry leaders recently, digital is the future of healthcare – and not just for mental health issues. The global DTx market projected to hit $13.1 billion by 2026, up from $3.4 billion in 2021.
Innovate or Alienate?
By the end of the day, about 130 Americans will have died to suicide – all of which are preventable. Mental health is a gnarly, twisty, pot-holed road filled with blind spots that requires new solutions, new ways to fill in the holes and guide new treatment pathways. It’s time for broader adoption of modern digital health solutions, either alone or combined with other treatments. At Curavit, we will continue providing virtual site support and decentralized/hybrid clinical trial services that align well for digital health product trials. We have seen, firsthand, the incredible impact of these products. Join Curavit on its mission to continue to innovate and stop alienating patients with mental health issues and their families.
Learn more about Curavit here, or email me at joel.morse@curavit.io to discuss your next trial.
By Joel Morse, CEO & Co-Founder
