Digital Therapeutics: A Different Treatment Modality for ADHD

This article reviews the role of digital therapeutics (DTx) as an adjunctive treatment modality for ADHD, highlighting FDA‑cleared products alongside investigational interventions. It summarizes clinical evidence, safety, and use considerations, positioning DTx as a complementary, nonpharmacologic component of multimodal ADHD care for both children and adults. 

Over the last decade, several digital therapeutics (DTx) have received U.S. Food and Drug Administration (FDA) clearance for the treatment of a variety of psychiatric conditions, including major depressive disorder, post-traumatic stress disorder, generalized anxiety disorder, and attention-deficit/hyperactivity disorder (ADHD).^1-4 As defined by the Digital Therapeutics Alliance, DTx are “health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.”⁵ Unlike general health and wellness applications, DTx make efficacy claims that are supported by clinical evidence, directly attributable to the software itself, and subject to regulatory review.⁵  

FDA-Cleared Digital Therapeutics for ADHD 

In 2020, EndeavorRx^® became the first FDA-cleared digital therapeutic for children aged 8 to 12 years with ADHD.⁴ EndeavorRx delivers treatment through an action-based video game played on a tablet or mobile device, designed to target neural systems involved in cognitive function.^4,6 Users complete missions that require focus and attention selectivity to collect specific targets while avoiding obstacles.⁶  

In the pivotal STARS‑ADHD trial, EndeavorRx demonstrated a statistically significant improvement in Test of Variables of Attention (TOVA) Attention Comparison Score (ACS) from baseline to week 4 compared with a control intervention in children aged 8 to 12 years with ADHD who were not receiving pharmacologic treatment (mean change from baseline to week 4: 0.93 in the EndeavorRx group [n = 180] vs 0.03 in the control group [n = 168]; P = 0.006).⁶ Significant improvements in TOVA ACS were also observed in the open‑label STARS‑Adolescent study, which evaluated 162 children aged 13 to 17 years with ADHD both on and off medication and supported subsequent label expansion.^6,7 Across these studies, 17 participants (4.97%) reported treatment-related adverse events. Events reported by more than 1% of participants included decreased frustration tolerance (2.34%) and headache (1.17%).⁶   

EndeavorRx is available by prescription only. Users are advised to engage with the program for 10 to 25 minutes per day, 5 days per week, over a 4-week period. The intervention is not intended to be used as a standalone treatment and is recommended as part of a broader, clinician-directed treatment plan.⁶  

In 2024, EndeavorOTC^® was cleared by the FDA as an over-the-counter DTx for adults with ADHD, utilizing the same proprietary technology as EndeavorRx.^8,9 In the open-label STARS-ADHD-Adults study, which included 221 adults with ADHD either on or off ADHD medication, participants experienced a significant improvement in TOVA ACS scores from baseline to 6 weeks (mean change: 6.46; P ≤ 0.0001).⁹ Treatment‑emergent adverse device events were reported by 11 participants (5.0%) and included nausea, headache, decreased frustration tolerance, arthritis, dizziness, fatigue, and somnolence. Although a prescription is not required, EndeavorOTC is similarly intended to be used alongside an existing ADHD therapeutic program. Recommended use is 10 to 25 minutes per day, 5 days per week, for 6 weeks.⁹ 
 

Investigational Digital Therapeutics  

Beyond FDA‑cleared products, several investigational DTx for ADHD have been evaluated in clinical studies. Attexis is an online intervention that combines psychoeducation, therapeutic exercises, and personalized techniques designed to improve attention. In a randomized controlled trial involving 337 adults with ADHD, participants receiving attexis in addition to treatment as usual (TAU) (n = 164) showed significantly greater reductions in ADHD symptom severity after 3 months compared with those receiving TAU alone (n = 173) (baseline‑adjusted mean difference in Adult ADHD Self‑Report Scale total score: −5.0 points, 95% CI: −6.4, −3.6, P < 0.001). No adverse events were attributed to the intervention.¹⁰ 

Another investigational DTx, Focus Pro, uses artificial intelligence to dynamically adjust the difficulty of computer‑based cognitive training exercises based on user performance.¹¹ In a double‑blind, randomized controlled trial of 85 children aged 6 to 11 years with ADHD, a significant improvement in TOVA scores at week 8 was observed in participants receiving Focus Pro in combination with methylphenidate compared with methylphenidate alone (P = 0.006, Cohen’s d = 0.809, 95% CI: 0.092, 1.527).¹¹ 

An Adjunctive Option to Consider 

Collectively, these studies suggest that DTx, when used as adjuncts to pharmacologic and other established treatments, may provide additional therapeutic benefit for both children and adults with ADHD. They may also address some of the geographic and time‑related barriers associated with traditional nonpharmacologic interventions, potentially expanding access to care.¹¹ DTx could become a complementary nonpharmacologic component of multimodal ADHD care, warranting continued evaluation alongside established treatment approaches.

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References:

1. Otsuka America Pharmaceutical, Inc. Otsuka and Click Therapeutics announce the U.S. Food and Drug Administration (FDA) clearance of Rejoyn™, the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder (MDD) symptoms. April 1, 2024. Accessed April 1, 2026. https://www.otsuka-us.com/news/rejoyn-fda-authorized 
2. Palo Alto Health Sciences. Palo Alto Health Sciences obtains FDA clearance for Freespira in treating post-traumatic stress disorder. December 19, 2018. Accessed April 1, 2026. https://freespira.com/press-release/palo-alto-health-sciences-obtains-fda-clearance-for-freespira-in-treating-post-traumatic-stress-disorder/ 
3. Big Health. US FDA grants clearance for DaylightRx. September 4, 2024. Accessed April 1, 2026. https://www.bighealth.com/news/us-fda-grants-clearance-for-daylightrx 
4. Akili Interactive Labs, Inc. Akili announces FDA clearance of EndeavorRx™ for children with ADHD, the first prescription treatment delivered through a video game. June 15, 2020. Accessed April 1, 2026. https://www.akiliinteractive.com/news-collection/akili-announces-endeavortm-attention-treatment-is-now-available-for-children-with-attention-deficit-hyperactivity-disorder-adhd-al3pw 
5. Digital Therapeutics Alliance. Guidance to Industry. June 2023. Accessed March 31, 2026. https://dtxalliance.org/wp-content/uploads/2023/06/Guidance-to-Industry-Classification-of-Digital-Health-Technologies-2023Jun05.pdf 
6. EndeavorRx®. Instructions for use. Revision V. Akili Interactive Labs, Inc; Updated June 2025. Accessed April 1, 2026. https://www.endeavorrx.com/instructions-for-use/ 
7. Akili Interactive Labs, Inc. EndeavorRx^®, world’s first and only prescription video game treatment, secures FDA label expansion for pediatric ADHD patients aged 13-17. News Release. Business Wire. December 18, 2023. Accessed April 1, 2026. https://www.businesswire.com/news/home/20231218891755/en/EndeavorRx-Worlds-First-and-Only-Prescription-Video-Game-Treatment-Secures-FDA-Label-Expansion-for-Pediatric-ADHD-Patients-Aged-13-17 
8. Akili Interactive Labs, Inc. Akili announces FDA authorization of EndeavorOTC, the first FDA clearance of a digital treatment for adults with ADHD through a video game. News Release. Business Wire. June 18, 2024. Accessed April 1, 2026. https://www.businesswire.com/news/home/20240618578815/en/Akili-Announces-FDA-Authorization-of-EndeavorOTC-the-First-FDA-Clearance-of-a-Digital-Treatment-for-Adults-with-ADHD-Through-a-Video-Game 
9. EndeavorOTC^® digital therapeutic software for attention deficit hyperactivity disorder instructions for use. Revision M. Akili Interactive Labs, Inc; Updated March 2025. Accessed April 1, 2026. https://www.endeavorotc.com/IFU/ 
10. D’Amelio R, Betz LT, Jow SM, et al. Effectiveness of attexis, a digital intervention based on cognitive behavioral therapy for adults with ADHD: a randomized controlled trial. Psychol Med. 2026;56:1-12. doi:10.1017/S0033291726103390 
11. Chen X, Wang S, Yang X, et al. Enhancing methylphenidate’s neurocognitive effects in pediatric ADHD with adaptive digital therapy: a randomized controlled trial. Psychol Res Behav Manag. 2026;19 :550150. doi:10.2147/PRBM.S550150