We close out May’s Mental Health Awareness Month with a landmark FDA regulatory decision that could have a great impact on mental health across the country. In a watershed moment for digital health innovation, the FDA recently granted clearance to Rejoyn, a first-of-its-kind mobile app that delivers cognitive behavioral therapy to help treat major depressive disorder. Developed by Click Therapeutics and Otsuka Pharmaceuticals, Rejoyn is part of an emerging class of “digital therapeutics” — software-based medical interventions that are poised to transform how we treat a wide range of physical and mental health conditions.
This move couldn’t come at a more pivotal time. We are confronting an unprecedented mental health crisis in our country. Depression rates have soared to historic highs, taking a devastating toll on individuals, families, communities and our economy. With existing treatment options like medications and in-person therapy leaving many needs unmet, there is an urgent demand for new approaches that can expand access to effective care.
Rejoyn’s clearance opens the door to a new era in which evidence-based software will work alongside – or even replace – traditional medical treatments. By leveraging the power and reach of mobile technology, digital therapeutics hold immense potential to engage patients in novel ways, personalize interventions in real-time, and capture previously unattainable insights to optimize outcomeWHERE DIGITAL THERAPEUTICS FIT IN
As an entrepreneurial leader building CareYaya Health Technologies at the forefront of the digital health revolution, I believe we are witnessing one of the most exciting and impactful developments in the history of medicine – one that will fundamentally reshape the future of healthcare itself.
THE ESCALATING BURDEN OF DEPRESSION IN MODERN SOCIETY
Depression has become pervasive in our modern world. In the United States alone, an estimated 21 million adults — roughly 8.3% of the population — experienced at least one major depressive episode in 2021. It was even higher in our younger population, with 18.6% of young adults ages 18-25 experiencing a major depressive episode.
DIGITAL THERAPEUTICS ARE REDEFINING TREATMENT
Rejoyn represents a groundbreaking advancement in the treatment of depression. Developed using evidence-based cognitive behavioral therapy (CBT) principles, the mobile app guides users through a series of interactive lessons and exercises designed to reframe negative thought patterns and build emotional resilience. What sets Rejoyn apart is its innovative use of an “emotional faces memory task”—a novel approach that targets specific brain regions implicated in depression, such as the amygdala and prefrontal corteSource: Nature Digital Medicine, A randomized, controlled pilot trial of the Emotional Faces Memory Task: a digital therapeutic for depression.
In essence, Rejoyn acts as a digital therapist in your pocket, providing 24/7 access to personalized, clinically validated mental health support. The app is intended to be used in conjunction with traditional treatments like medication and in-person therapy, offering an extra layer of support and reinforcement between sessions. By delivering CBT in a convenient, engaging, and data-driven format, Rejoyn has the potential to significantly boost the effectiveness of depression treatment and improve long-term outcomes.
Rejoyn is just one example of a broader trend in digital medicine. Digital therapeutics, or DTx, are software-based interventions that are clinically validated to prevent, manage, or treat a specific medical condition. These products undergo rigorous testing and regulatory oversight to ensure safety and efficacy, setting them apart from the vast sea of consumer wellness apps.
The DTx market is rapidly expanding, with products targeting a wide range of conditions beyond mental health. Pear Therapeutics, for instance, has developed FDA-cleared apps for substance use disorder, opioid use disorder, and chronic insomnia. Akili Interactive’s video game-based treatment for pediatric ADHD became the first FDA-approved digital therapeutic in 2020. Other companies are developing DTx for conditions like diabetes, Alzheimer’s, and multiple sclerosis.
The potential of digital therapeutics lies in their ability to expand access to evidence-based treatments, improve patient engagement and adherence, and deliver real-time insights to clinicians. By harnessing the power of software and data analytics, DTx can personalize interventions to each individual’s unique needs and behaviors, optimizing the therapeutic approach in ways that are simply not possible with traditional medicines alone. As the field continues to evolve, we can expect to see even more sophisticated capabilities emerge, from predictive algorithms that can detect early signs of relapse to closed-loop systems that automatically adjust treatment based on biometric data.
INNOVATIVE APPS AS BEHAVIORAL THERAPY
While Rejoyn marks a significant milestone as the first FDA-cleared digital therapeutic for depression, it is part of a broader wave of innovation that is reimagining the future of medicine. The global digital therapeutics market is expected to grow from $6.1 billion in 2023 to $21.9 billion by 2028, fueled by a surge of investment and a growing body of clinical evidence.
One of the key players in this space is Pear Therapeutics, whose reSET app, delivers cognitive behavioral therapy for substance use. This has been shown to significantly increase abstinence rates compared to standard treatment alone. Another notable example is Akili Interactive’s EndeavorRx, a video game-based treatment for pediatric ADHD that became the first FDA-approved digital therapeutic in 2020. The game, which is designed to target and stimulate specific neural networks involved in attention function, has demonstrated improved attention scores in clinical trials. Below is a fascinating video overview of the video-game treatment.
Beyond mental health, digital therapeutics are being developed for a wide range of chronic conditions. Welldoc’s BlueStar app, for instance, helps people with type 2 diabetes manage their condition through personalized coaching, while Propeller Health’s platform uses sensor-equipped inhalers to track medication usage and provide real-time feedback to patients with asthma and COPD. CareYaya Health Technologies has developed a first-of-its-kind AI-powered digital therapeutic for older adults with Parkinson’s.
As the digital therapeutics landscape continues to mature, we can expect to see even more targeted and sophisticated interventions emerge. Researchers are exploring the potential of digital biomarkers—such as changes in voice, facial expressions, or smartphone usage patterns—to predict and prevent mental health crises. Machine learning algorithms could be used to optimize treatment plans based on an individual’s unique biology and behavior. And as wearable sensors and smart devices become increasingly ubiquitous, there will be new opportunities to integrate digital therapeutics seamlessly into patients’ daily lives.
Of course, significant challenges remain. Reimbursement models for digital therapeutics are still evolving, and there are important questions around data privacy, security, and equity of access that will need to be addressed. But with hundreds of millions of dollars flowing into the space and a growing number of pharma and health tech partnerships, the momentum behind digital therapeutics is undeniable. As an industry, we have only begun to scratch the surface of what is possible when we leverage the power of software and data to augment and enhance traditional medical care.
A NEW ERA OF PERSONALIZED, ACCESSIBLE, DATA-DRIVEN CARE
As we stand at the threshold of a new era in medicine, the FDA’s clearance of Rejoyn represents a powerful validation of the transformative potential of digital therapeutics. By harnessing the power of software, data, and artificial intelligence, we have the opportunity to fundamentally reimagine how we approach the prevention, management, and treatment of disease.
In the realm of mental health, digital therapeutics like Rejoyn offer a promising path forward in the fight against the global epidemic of depression. By making evidence-based treatments more accessible, engaging, and responsive to individual needs, these innovations have the potential to bridge the vast gap between those who need help and those who actually receive it. And as we continue to refine and advance these technologies, we can envision a future in which personalized, precisely targeted interventions are delivered seamlessly in the moment they are needed most.
But the implications of digital therapeutics extend far beyond the domain of mental health. As our understanding of the complex interplay between biology, behavior, and environment continues to evolve, so too will our ability to develop targeted, data-driven interventions for a wide range of conditions. From chronic diseases like diabetes and heart disease to neurological disorders like Alzheimer’s and Parkinson’s, digital therapeutics hold the potential to transform the way we approach some of the most pressing health challenges of our time.
Of course, realizing this potential will require a collective effort from across the healthcare ecosystem. We will need to invest in research and development, build new models for reimbursement and regulation, and ensure that these technologies are developed and deployed in an equitable and ethical manner. But if we can rise to meet these challenges, the rewards will be immeasurable.
As we look to the future, I am filled with a sense of optimism and excitement. We are standing at the precipice of a digital health revolution that has the power to touch billions of lives and reshape the very fabric of our society. By harnessing the limitless potential of technology in service of our shared humanity, we can create a world in which every individual has access to the personalized, compassionate, and data-driven care they need to live their healthiest and most fulfilling lives. The road ahead may be long and complex, but with innovation as our guide and empathy as our compass, there is no limit to what we can achieve.
Editor’s Note: Neal K. Shah is the CEO of CareYaya Health Technologies, one of the fastest-growing health tech startups in America. He runs a social enterprise and applied research lab utilizing AI and human capital innovation to advance health equity through technology. Neal is a “Top Healthcare Voice” on LinkedIn with a 30k+ following, having led partnerships with top healthcare systems in America.