Doctors Are Now Prescribing Video Games and AI Apps to Treat Mental Health
The FDA has cleared a new class of digital therapeutics for conditions like ADHD and depression, shifting software from a source of screen-time anxiety to a clinically validated medical treatment.
By Factlen Editorial Team
- Clinical Adopters
- Physicians and industry groups who view digital therapeutics as a scalable, safe adjunct to traditional medication and therapy.
- Regulatory Evaluators
- Agencies and editorial teams focused on establishing strict safety, efficacy, and classification standards for software as a medical device.
- Evidence Skeptics
- Researchers who urge caution regarding small effect sizes and the high placebo response seen in digital psychiatric trials.
- Access Advocates
- Public health experts focused on how software can bridge the geographic and financial gaps in psychiatric care.
What's not represented
- · Game Developers & UX Designers
- · Teachers observing behavioral changes in classrooms
Why this matters
As the mental health crisis deepens and psychiatric waitlists grow, FDA-cleared software offers a scalable, non-chemical treatment option. Understanding which apps are backed by clinical trials—and which are just digital placebos—is becoming essential for patients and parents navigating modern healthcare.
Key points
- Digital therapeutics (DTx) are FDA-cleared software programs prescribed to treat medical conditions.
- EndeavorRx, a prescription video game, improved objective attention measures in children with ADHD by 36%.
- Rejoyn, a smartphone app for depression, reduced symptom severity in adults, though its edge over a placebo app was debated.
- Unlike consumer wellness apps, DTx products require randomized controlled trials and a doctor's prescription.
- In 2025, Medicare and Medicaid established billing codes for digital mental health treatments, paving the way for insurance coverage.
Screen time has long been cast as the primary villain in the modern pediatric mental health crisis, blamed for everything from shortened attention spans to rising anxiety. But a growing coalition of physicians and researchers is attempting to flip that paradigm entirely. Rather than simply advising parents to confiscate devices, pediatricians are increasingly looking to harness the screen as a delivery mechanism for targeted psychiatric treatment. This shift represents a fundamental rethinking of digital engagement, moving away from the idea that all screen time is inherently toxic and toward a model where clinically validated software can be prescribed as medicine to actively repair neural pathways.[1]
This transition is being driven by the rapid maturation of Digital Therapeutics, commonly referred to as DTx. It is crucial to distinguish this emerging class of treatments from the thousands of consumer wellness applications—like Calm or Headspace—that currently flood app stores. Wellness apps are direct-to-consumer products designed for general relaxation and lifestyle support, lacking formal clinical validation. In contrast, digital therapeutics are classified by federal regulators as Software as a Medical Device. They are engineered to directly treat, manage, or prevent specific medical disorders, utilizing code as the active therapeutic ingredient rather than a chemical compound.[4][6]
To earn this rigorous medical designation, software developers cannot rely on user reviews or internal engagement metrics. They must subject their applications to the same gold-standard scrutiny required of traditional pharmaceuticals: double-blind, randomized controlled trials. Only after demonstrating statistically significant safety and efficacy data can these products receive clearance from federal regulators. Once cleared, they are locked behind a pharmacy wall, requiring a formal prescription from a licensed healthcare provider before a patient can download and activate the software on their personal device.[4][6]

The evidence base supporting these digital interventions has expanded significantly over the past few years. As of 2026, regulators have authorized more than a dozen distinct digital mental health products. This portfolio of prescription software now targets a wide spectrum of psychiatric and behavioral conditions, including chronic insomnia, substance use disorder, opioid use disorder, generalized anxiety, and postpartum depression. However, the most intense clinical interest—and the most rigorous debate over efficacy—has centered on treatments developed for attention-deficit/hyperactivity disorder and major depressive disorder.[6]
The foundational claim of the pediatric digital therapeutic movement is that highly engineered video games can objectively improve attention function in children with ADHD. The pioneer in this specific space is EndeavorRx, developed by Akili Interactive. In 2020, it made medical history by becoming the first video game to ever be cleared by federal regulators as a prescription medical treatment, specifically authorized for children between the ages of eight and twelve who have demonstrated primarily inattentive or combined-type ADHD.[2]
EndeavorRx is explicitly not designed for leisure or entertainment, despite its colorful interface. The software runs on a proprietary algorithm known as the Selective Stimulus Management Engine. During a standard treatment session, a child is tasked with steering a character along a continuously moving course. As they navigate, the engine bombards them with specific visual and auditory stimuli, forcing the patient to constantly multitask, prioritize targets, and actively ignore engineered distractions. The algorithm continuously adapts in real-time, increasing the cognitive difficulty the moment the child's attention improves.[2][5]

The clinical data supporting this digital intervention is substantial. Across five clinical studies involving more than 600 children, researchers measured the game's impact using the Test of Variables of Attention, a widely accepted objective computer-based assessment. The pivotal trial revealed a 36 percent improvement in at least one objective measure of attention among the children who used the software. Furthermore, clinical responder rates ranged between 48 and 50 percent after just one month of daily 25-minute gameplay sessions, suggesting a significant therapeutic impact for half of the patient population.[2][5]
The clinical data supporting this digital intervention is substantial.
However, this evidence comes with strict and transparent caveats regarding its real-world application. Regulatory authorization documents explicitly note that while the video game successfully improves computer-assessed attention metrics, it "may not display benefits in typical behavioral symptoms, such as hyperactivity." Because the software does not necessarily translate to a calmer child in a physical classroom setting, it is authorized strictly as an adjunct therapy. It is intended to be used alongside traditional clinician-directed therapy, educational programs, and standard stimulant medications, rather than serving as a standalone cure.[2]
Beyond pediatric ADHD, the digital therapeutic industry has recently expanded its focus to adult psychiatric care, making the claim that smartphone applications can actively reduce the severity of Major Depressive Disorder. In the spring of 2024, regulators cleared Rejoyn, a prescription application developed jointly by Click Therapeutics and Otsuka Pharmaceutical. The software is authorized for adults aged 22 and older who are already taking standard antidepressant medications but are still experiencing partial, lingering depressive symptoms that disrupt their daily lives.[3]
Rejoyn operates on the theory of neuroplasticity, targeting specific working memory deficits that are heavily associated with clinical depression. The core of the six-week digital treatment involves a novel cognitive emotional training exercise. Users are presented with a rapid sequence of faces depicting various complex emotions. They are then required to recall the exact sequence and identify the emotions, a task designed to rebuild neural connections and rework how the patient's brain processes and stores emotional material, supplemented by brief cognitive-behavioral therapy lessons.[3]
The pivotal clinical trial for Rejoyn involved 354 adults diagnosed with current Major Depressive Disorder. At the beginning of the study, participants scored an average of 28 on the Montgomery-Asberg Depression Rating Scale, a clinical benchmark indicating moderate depression. Participants were randomly divided, with half receiving the active Rejoyn application and the other half receiving a placebo application. After six weeks of consistent use, the average depression score among the Rejoyn users dropped significantly from 28 down to 19, indicating a meaningful reduction in symptom severity.[3]

Despite this drop, the strength of the evidence has been heavily debated within the psychiatric community due to the performance of the control group. The patients using the "sham app"—a placebo game that required similar effort but only involved matching shapes instead of emotional faces—also saw their depression scores drop significantly, landing at an average of 21. Because the two-point difference between the active therapeutic app and the digital placebo was not deemed statistically significant on the trial's primary outcome measure, some experts urge caution, questioning how much of the benefit is driven by the specific emotional training versus the general placebo effect of structured daily engagement.[3]
Even with ongoing debates over the exact magnitude of their clinical effect sizes, the safety profile of digital therapeutics remains a massive draw for both patients and prescribing physicians. Traditional psychiatric medications often carry heavy burdens, ranging from severe appetite suppression and sleep disruption in pediatric ADHD stimulants to weight gain and emotional blunting in adult antidepressants. In stark contrast, the most common adverse event reported in the EndeavorRx trials was mild frustration with the game's difficulty, while the Rejoyn trials reported virtually no adverse effects, offering a uniquely low-risk adjunct for struggling patients.[2]
Historically, the primary hurdle preventing the widespread adoption of digital therapeutics has been financial rather than clinical. For years, insurance companies balked at the idea of reimbursing patients for software downloads, leaving these treatments inaccessible to lower-income populations. However, the reimbursement landscape shifted dramatically in 2025 when the Centers for Medicare and Medicaid Services established dedicated billing codes specifically for digital mental health treatments. This regulatory milestone provided a clear pathway for providers to bill for software interventions, signaling a permanent transition toward mainstream insurance coverage.[4]
Looking ahead, the medical community is demanding increasingly rigorous standards for the next generation of therapeutic software. Leading pediatricians and psychiatric researchers are actively pushing the digital health industry to permanently abandon standard tech-industry "engagement metrics"—which merely measure how long an app can hold a user's attention—in favor of designing tools that deliver durable, real-world developmental outcomes. As the technology evolves, the ultimate goal is to create a highly regulated ecosystem where a digital prescription is trusted with the exact same confidence as a chemical one.[1][7]
How we got here
June 2020
The FDA clears EndeavorRx, making it the first prescription video game authorized for ADHD treatment.
March 2024
Rejoyn becomes the first digital therapeutic cleared by regulators for Major Depressive Disorder.
January 2025
CMS establishes new billing codes for digital mental health treatments, expanding patient access.
June 2026
Pediatricians push for stricter clinical guidelines, demanding AI tools measure developmental outcomes rather than engagement.
Viewpoints in depth
Clinical Adopters
Physicians and industry groups who view digital therapeutics as a scalable, safe adjunct to traditional medication and therapy.
For many prescribing physicians, the appeal of digital therapeutics lies in their unparalleled safety profile and scalability. Traditional psychiatric medications often come with a cascade of side effects—from sleep disruption to metabolic changes—that can cause patients to abandon treatment. Software interventions offer a non-chemical alternative that can be layered on top of existing care plans without the risk of drug interactions. Furthermore, industry advocates argue that as psychiatric waitlists stretch into months, prescription apps provide immediate, evidence-based intervention that patients can access from their living rooms the moment they receive a diagnosis.
Regulatory Evaluators
Agencies and editorial teams focused on establishing strict safety, efficacy, and classification standards for software as a medical device.
Regulators approach digital therapeutics with a focus on strict categorization and risk management, ensuring that the line between a consumer wellness app and a medical device remains absolute. The FDA requires that any software making medical claims prove its efficacy through randomized controlled trials, just like a pharmaceutical drug. This perspective emphasizes that while the barrier to entry for coding an app is low, the barrier to prescribing it must remain high. Evaluators stress that these tools are currently cleared only as adjuncts to traditional care, not as standalone replacements for human clinicians or essential medications.
Evidence Skeptics
Researchers who urge caution regarding small effect sizes and the high placebo response seen in digital psychiatric trials.
A vocal contingent of psychiatric researchers urges caution when interpreting the clinical trial data for digital therapeutics. They point out that the 'placebo effect' in digital trials is remarkably high; patients often show significant improvement simply from the structured routine of interacting with a 'sham app' daily. In cases like the Rejoyn depression app, skeptics highlight that the difference in symptom reduction between the active software and the digital placebo was not statistically significant on primary measures. They argue that until software can prove it drives real-world behavioral changes—not just improvements on computer-based tests—its clinical value remains uncertain.
Access Advocates
Public health experts focused on how software can bridge the geographic and financial gaps in psychiatric care.
Public health advocates view digital therapeutics primarily through the lens of health equity. In the United States, a significant percentage of rural and lower-income communities live in 'psychiatric deserts' with zero access to specialized mental health professionals. For these populations, a prescription smartphone application represents a critical lifeline. This camp heavily lobbied for the 2025 CMS billing codes, arguing that true equity is only achieved when Medicare and Medicaid reimburse for digital treatments, ensuring that cutting-edge psychiatric software isn't restricted exclusively to patients who can afford high out-of-pocket costs.
What we don't know
- Whether digital therapeutics can produce long-term behavioral changes outside of the specific computer-based tasks they train.
- How broadly private insurance companies will adopt the new CMS billing codes to cover the cost of prescription apps.
- The exact mechanism by which 'sham apps' (digital placebos) produce significant symptom reductions in psychiatric trials.
Key terms
- Digital Therapeutic (DTx)
- Evidence-based, clinically validated software interventions prescribed by a doctor to prevent, manage, or treat a medical disorder.
- Software as a Medical Device (SaMD)
- Software intended to be used for medical purposes that performs these functions without being part of a physical hardware medical device.
- Sham App
- A placebo application used in clinical trials that requires similar user effort but lacks the active therapeutic mechanism, used to measure true efficacy.
- Neuroplasticity
- The brain's ability to reorganize itself by forming new neural connections, which digital therapeutics attempt to harness through targeted cognitive exercises.
Frequently asked
What is the difference between a digital therapeutic and a wellness app?
Wellness apps are direct-to-consumer products meant for general relaxation. Digital therapeutics (DTx) are FDA-cleared medical devices that require a prescription and are backed by randomized controlled trials.
Can a video game really treat ADHD?
Yes, EndeavorRx is FDA-cleared to improve objective measures of attention in children with ADHD, though the FDA notes it may not improve behavioral symptoms like hyperactivity in the classroom.
Does health insurance cover prescription apps?
Coverage is rapidly evolving. In 2025, Medicare and Medicaid introduced new billing codes for digital mental health treatments, paving the way for broader private insurance reimbursement.
Sources
[1]STAT NewsClinical Adopters
Opinion: I’m a pediatrician. I want to prescribe the right AI to my patients
Read on STAT News →[2]U.S. Food and Drug AdministrationRegulatory Evaluators
De Novo Classification Request for EndeavorRx
Read on U.S. Food and Drug Administration →[3]Psychiatric NewsEvidence Skeptics
Rejoyn: First App Cleared by FDA for Depression; Cost, Efficacy Unclear
Read on Psychiatric News →[4]American Psychological AssociationAccess Advocates
Digital mental health technologies
Read on American Psychological Association →[5]Digital Therapeutics AllianceClinical Adopters
EndeavorRx® - Digital Therapeutics Alliance
Read on Digital Therapeutics Alliance →[6]MDPIAccess Advocates
Digital Mental Health: A Narrative Review of FDA-Authorized Products for Psychiatric Treatment
Read on MDPI →[7]Factlen Editorial TeamRegulatory Evaluators
Synthesis by Factlen editorial team
Read on Factlen Editorial Team →
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