Most people now manage pieces of their health on a phone, from steps to sleep to blood pressure cuffs that talk to the cloud. Digital therapeutics go a step further. They are not wellness trackers or meditation apps. They are medical treatments delivered by software, built on clinical evidence, cleared by regulators, and prescribed or recommended by clinicians to prevent, manage, or treat a diagnosis. That is the core idea, and the promise is simple. If software can deliver the right therapeutic experience, at the right dose, with the right feedback loop, care becomes more personal and more continuous. These are evidence-based medical interventions delivered by software.

Addiction, where access and engagement are make-or-break, was an early proving ground. The FDA granted a De Novo authorization to reSET for substance use disorder in 2017 and later cleared reSET-O for opioid use disorder. These are prescription digital therapeutics designed to deliver elements of cognitive behavioral therapy and contingency management in concert with clinician care. Adding reSET to standard outpatient treatment improved abstinence and retention compared with standard care alone. Software can extend evidence-based therapy beyond the clinic walls and help patients stay in treatment when it matters most.

The most famous prescription digital therapeutic (PDT) example is a video game. EndeavorRx was the first FDA-authorized PDT for pediatric ADHD. It looks like play, but it is built to train attention control systems using adaptive algorithms and precise task designs, and it must be prescribed by a clinician. In 2020 the FDA granted authorization after reviewing data that showed improvements in attention function for children meeting ADHD criteria. The product label and the company’s materials are clear about scope. It is part of a treatment plan, not a replacement for medications or therapy when those are indicated. Still, symbolism matters. A child can receive a doctor’s order for a game that treats attention as a trainable capacity, not only a symptom to medicate.

Depression has now crossed the same threshold. In April 2024, the FDA cleared Rejoyn, a PDT for adults with major depressive disorder who are on antidepressant medication. It delivers a structured program on a smartphone as an adjunct to clinician-managed care, and it is intended to reduce depressive symptoms. This is not a motivational app. It is regulated, prescription software, grounded in a mechanism-driven approach that blends cognitive and emotional training with behavioral strategies over a defined course. The signal here is strong. Regulators have opened a path for software to take an official role in treating one of the most common conditions in medicine.

Schizophrenia shows where the field is heading next. Negative symptoms like anhedonia, avolition, and reduced expressivity are stubborn, function-sapping, and poorly served by our current medications and treatments. This is where digital therapeutics may help by targeting motivational and experiential systems through high-frequency, skills-based exercises tied to real-world reinforcement. The pivotal CONVOKE trial, run by Boehringer Ingelheim and Click Therapeutics, tested an investigational prescription digital therapeutic as an adjunct to antipsychotic care and reported that it met its primary endpoint with a statistically significant reduction in experiential negative symptoms. Schizophrenia patients and families could soon have a software adjunct that tackles the part of the illness that most dictates quality of life.

So what exactly makes a digital therapeutic different from a “health app” on your home screen?

• First, clinical validation: These products are expected to show benefit in controlled trials and to disclose risks and limitations.
• Second, regulatory oversight: Several mental health PDTs now sit under a specific FDA device classification for computerized behavioral therapy, which comes with special controls.
• Third, integration: The best digital therapeutics are designed to slot into real care with prescribing, monitoring, and outcome tracking, not to float on an island of self-help.

These guardrails do not make software perfect. They make it accountable, which is what patients deserve.

For ADHD, what should families expect in practice? A clinician evaluates the child using standard methods. If attention training through EndeavorRx is appropriate, the family receives a prescription and sets up a defined treatment schedule. The child plays a structured game that quietly shifts difficulty to target attention control. The family and clinician monitor progress and adjust the broader plan. This is treatment as daily practice, not as a once-a-month refill. Some payers have started to engage. Even when coverage is uneven, families report they value having an option that is skill-building and stigma-light.

For depression, Rejoyn’s clearance matters because it validates a familiar but hard problem. Many adults take an antidepressant and still struggle with mood, cognition, and motivation between visits. A phone is not a panacea, but a structured, adjunctive program can reinforce behavioral activation, emotional processing, and cognitive skills on the days when activation is low and rumination is high. Because it is prescription software tied to the chart, clinicians can align the digital work with therapy goals and medication changes. This is the promise of hybrid care that leverages human connection and software discipline together.

For addiction, the lesson is that engagement wins. PDTs like reSET and reSET-O bring therapy into the times and places where cravings, cues, and setbacks happen, not just into 45-minute sessions. They also keep score in a way that supports transparency and reinforcement. In every clinic I have led, adherence and retention shape outcomes more than any other factor. A tool that measurably increases both is not a gadget; it is part of the treatment team.

The future will not be friction-free. Coverage remains patchy. Workflow integration still takes effort. Some products will not meet endpoints or will fade if they cannot prove real-world value. Patients deserve clear labeling, realistic claims, and strong privacy protections. All true. Yet the arc is bending toward treatments that meet patients where they live, that coach the brain to do what medications cannot, and that help clinicians see between visits. When a product earns authorization, that is a floor, not a ceiling. The next mile is reimbursement, interoperability, and equity-minded deployment so these tools reach families outside the early-adopter bubble.

Here is how I talk about digital therapeutics with patients and the public.

• First: This is medicine, not a replacement for human care. It works best alongside clinicians who set goals, track outcomes, and adjust the plan.
• Second: Access matters. Ask your clinician whether a PDT is appropriate and whether your plan covers it, and if it does not, ask why.
• Third: Expect measurement. Good software makes progress visible, which helps you and your clinician decide what to keep, what to change, and when to stop.
• Fourth: Be hopeful and critical at once. Demand evidence. Also notice what is new. Your treatment can now follow you into your day, not wait for your next appointment.

If you want a single takeaway, try this. Digital therapeutics move parts of care from the exam room into your routine, where habits form and life happens. When they are thoughtfully chosen and well-supported, they do not replace your clinician. They extend your team and give you more chances to get better. That is a future worth building, and it is already underway in ADHD, depression, addiction, and, if the recent schizophrenia data hold, in the most stubborn corners of serious mental illness as well.

Muhamad Aly Rifai is a nationally recognized psychiatrist, internist, and addiction medicine specialist based in the Greater Lehigh Valley, Pennsylvania. He is the founder, CEO, and chief medical officer of Blue Mountain Psychiatry, a leading multidisciplinary practice known for innovative approaches to mental health, addiction treatment, and integrated care. Dr. Rifai currently holds the prestigious Lehigh Valley Endowed Chair of Addiction Medicine, reflecting his leadership in advancing evidence-based treatments for substance use disorders.

Board-certified in psychiatry, internal medicine, addiction medicine, and consultation-liaison (psychosomatic) psychiatry, Dr. Rifai is a fellow of the American College of Physicians (FACP), the American Psychiatric Association (FAPA), and the Academy of Consultation-Liaison Psychiatry (FACLP). He is also a former president of the Lehigh Valley Psychiatric Society, where he championed access to community-based psychiatric care and physician advocacy.

A thought leader in telepsychiatry, ketamine treatment, and the intersection of medicine and mental health, Dr. Rifai frequently writes and speaks on physician justice, federal health care policy, and the ethical use of digital psychiatry.

You can learn more about Dr. Rifai through his Wikipedia page, connect with him on LinkedIn, X (formerly Twitter), Facebook, or subscribe to his YouTube channel. His podcast, The Virtual Psychiatrist, offers deeper insights into topics at the intersection of mental health and medicine. Explore all of Dr. Rifai’s platforms and resources via his Linktree.