Research: Prescription Digital Therapeutics Effectively Address ADHD, Anxiety in Adults

January 17, 2026

Digital mental health treatments like LumosityRx, a new prescription digital therapeutic (PDT) for ADHD, and interventions like digital cognitive behavioral therapy (DCBT) for anxiety have been shown to be safe and effective adjunct therapies, according to new research.

“Harnessing digital therapeutics to expand working memory and improve focus and concentration is at the forefront of clinical development and research,” says Greg Mattingly, M.D., an associate clinical professor at Washington University School of Medicine who has been a principal investigator in trials for Akilli Interactive, Lumos Labs, and other digital therapeutic manufacturers.

FDA Clears LumosityRX

Lumos Labs obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for LumosityRx on December 10, 2025. The brain training app guides patients through 13 clinically validated games targeting attention, working memory, and cognitive control; it is indicated for use in adults ages 22 to 55 with primarily inattentive or combined-type ADHD. According to the manufacturer, LumosityRx targets attention but does not aim to treat all behavioral symptoms of ADHD, such as hyperactivity.¹

LumosityRx is not intended to be a standalone treatment but part of a broader treatment plan that may include clinician-directed therapy, medication, and/or educational programs. Research confirms that “stimulant medications are most effective, and combined medication and psychosocial treatment is the most beneficial treatment option for most adult patients with ADHD.” ² In addition, the PDT may not be appropriate for users with photo-sensitive epilepsy, color blindness, or physical limitations that restrict the use of a mobile device.

FDA clearance was based on results from the GAMES Study, a randomized, double-blind, sham-controlled clinical trial that included 560 unmedicated participants aged 22 to 55 years with an ADHD diagnosis across 13 U.S. clinical sites. Participants were randomly assigned to use LumosityRx or sham game-play therapy for approximately 15 minutes daily for 9 weeks.

Participants using LumosityRx improved their sustained and selective attention by 1.1 points compared to 0.3 points in the control group on the Test of Variables of Attention (TOVA) Attention Comparison Score (ACS); 44.2% demonstrated “clinically meaningful” gains in attention, defined as improvements of greater than 1.4 points. Users also reported a “clinically meaningful” increase of 8.7 points on the Adult ADHD Quality of Life (AAQoL) questionnaire.

Blinded clinician assessments rated approximately 1 in 3 participants in the PDT group as “much improved” or “better” compared to the controls on the Clinical Global Impression–Improvement (CGI-I) scale.

No serious adverse events were reported, and fewer than 1% of participants experienced treatment-related adverse events.

“Adult ADHD is often misunderstood, and many patients still struggle to find treatment options that fit into their lives,” said Ann Childress, M.D., principal investigator of the trial and president of the Center for Psychiatry and Behavioral Medicine, Inc., in Las Vegas. “Digital therapeutics like LumosityRx open up new possibilities: clinically validated, highly engaging, and accessible from a mobile device.”

DCBT for Anxiety

Digital therapeutics gained further validation in a new study published in JAMA Network Open that found smartphone-delivered digital cognitive behavioral therapy (DCBT) provided significant and sustained benefits to adults with general anxiety disorder (GAD).³

Symptom remission occurred in 71% of participants receiving DCBT at 10 weeks and increased to 77.7% at 24 weeks, according to the study. In comparison, remission occurred in 34.6% of the control group at week 10 and increased to 52% at week 24. The DCBT group reported significant reductions in depressive symptoms and sleep disturbance at weeks 10 and 24 compared to the control group.

Participants in the DCBT intervention group received access to DaylightRx, a mobile digital therapeutic for generalized anxiety that received FDA clearance in September 2024. DaylightRx uses CBT techniques, such as cognitive restructuring, applied relaxation, stimulus control, avoidance reduction, mindfulness, problem-solving, and imaginal exposure, and delivers them through interactive lessons and guided practices.

Members of the psychoeducation (control) group received online access to evidence-based psychoeducation for anxiety self-management, which included education on the symptoms, prevalence, causes, and consequences of GAD, as well as advice on lifestyle changes (e.g., increased sleep and exercise) that individuals could make to reduce anxiety.

The randomized clinical trial took place between March 8, 2023, and February 28, 2024, and it involved 351 adults aged 22 years or older diagnosed with GAD. Participants completed online self-report questionnaires at 6, 10, and 24 weeks, and they participated in video visits with a blinded independent evaluator at 10 and 24 weeks.

Why Consider Digital Therapeutics?

Cognitive behavioral therapy (CBT) and pharmacotherapy are first-line interventions for GAD.⁴

However, the study’s authors explained, systematic barriers, such as an inadequate number of trained therapists, the burden of in-person therapy, and stigma, may make CBT inaccessible for patients.^{5, 6}

“Digital CBT programs may have the potential to overcome barriers to effective treatment and expand therapist reach and impact,” they wrote. “The consistent evidence for the efficacy of this smartphone-accessible DCBT suggests it is a scalable, first-line treatment option for adults with GAD.”⁷

For the first time, the 2025 Medicare Physician Fee Schedule (MPFS) issued a final rule that includes reimbursement opportunities for FDA-cleared digital mental health treatments, potentially easing access to digital therapeutics in clinical settings.

EndeavorRx, developed by Akili Interactive (now part of Virtual Therapeutics), was the first FDA-approved game-based digital therapeutic device for the treatment of primarily inattentive or combined-type ADHD in children ages 8 to 12. Akili used its proprietary technology to develop EndeavorOTC, the first FDA-authorized over-the-counter digital therapeutic treatment designed to treat symptoms of inattentive ADHD in adults 18 and older. Neither EndeavorRx nor EndevaorOTC are intended to be used as a stand-alone therapeutic or a substitute for ADHD medication.

All ADHD treatment decisions should be made in consultation with a licensed medical provider.

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