Digital Therapeutics Evidence Summary
Digital Therapeutics Evidence Summary
Quick Reference Tool | PsychHQ Source: Modules 5 & 10, Psychosocial Interventions and Emerging Directions | Last Updated: February 2026
What Are Digital Therapeutics?
Digital therapeutics (DTx) are software-based interventions that deliver evidence-based therapeutic interventions to patients. They are distinct from wellness apps and general health tools. The FDA distinguishes between Prescription Digital Therapeutics (PDTs), which undergo rigorous premarket review, and consumer wellness applications, which do not. This distinction matters clinically: only PDTs have undergone the kind of evaluation that supports clinical recommendations.
EndeavorRx (AKL-T01): The Only FDA-Authorized PDT for ADHD
| Parameter | Detail |
|---|---|
| FDA Status | Authorized June 2020 (De Novo pathway, DEN200026) — first game-based therapeutic for any condition |
| Indication | Improving attention function in children aged 8–12 (later expanded to adolescents) with primarily inattentive or combined-type ADHD |
| Mechanism | Selective Stimulus Management (SSM) Engine — proprietary multitasking algorithm targeting the fronto-parietal attention network through sensory discrimination and motor response tasks |
| Treatment Protocol | 25 minutes/day, 5 days/week, for 4 weeks |
| FDA Label Caveat | "Not intended as a standalone treatment. Should be considered as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs" |
| Manufacturer | Akili Interactive |
Pivotal Trial Evidence
STARS-ADHD Trial (Kollins et al., 2020, Lancet Digital Health)
| Parameter | Detail |
|---|---|
| Design | Multicenter, randomized, double-blind, controlled trial |
| Sample | N = 348 children aged 8–12 with ADHD |
| Active arm | EndeavorRx (SSM Engine targeting attention networks) |
| Control arm | Digital word game matched for engagement but lacking the specific multitasking algorithm |
| Primary endpoint | Change in Test of Variables of Attention (TOVA) Attention Performance Index |
| Duration | 4 weeks |
Results
| Measure | EndeavorRx | Stimulant Medications (for comparison) |
|---|---|---|
| Objective attention (TOVA API) | Cohen's d ≈ 0.35–0.40 (statistically significant) | Cohen's d ≈ 0.8–1.0 |
| Parent-rated ADHD symptoms (ADHD-RS) | Not statistically significant | Large, consistent effects |
| Parent-rated impairment (IRS) | Not statistically significant | Significant improvement |
| Most common adverse events | Frustration, headache (mild, self-limited) | Appetite suppression, insomnia, CV effects |
Interpretation
EndeavorRx improved performance on an objective computer-based attention test, but this improvement did not consistently translate into parent-observed behavioral change in real-world settings. The effect size of 0.35–0.40 is modest — for context, stimulants produce effect sizes of 0.8–1.0 on core symptom measures, and behavioral parent training produces effect sizes of 0.41–0.90.
Clinical Pearl: The TOVA improvement represents near-transfer (the game improved performance on a task similar to the game). The ADHD-RS non-significance represents failed far-transfer (the improvement did not carry over to real-world behavioral outcomes). This near-transfer vs. far-transfer distinction is the central issue for all computerized interventions in ADHD.
STARS-Adjunct Trial (Kollins et al., 2021, npj Digital Medicine)
| Parameter | Detail |
|---|---|
| Design | Open-label adjunct trial |
| Population | Children already taking stable stimulant medication |
| Key Finding | ~68% of caregivers reported clinically meaningful improvement on ADHD-RS when EndeavorRx was added to stimulant medication |
| Interpretation | Greater clinical utility as an adjunct to pharmacotherapy than as a standalone intervention |
| Limitation | Open-label design — families knew the child was using the therapeutic game, introducing expectancy bias |
Comparison: EndeavorRx vs. Other Non-Pharmacological Interventions
| Intervention | Effect Size (core ADHD symptoms) | Evidence Level | Near vs. Far Transfer |
|---|---|---|---|
| EndeavorRx | d ≈ 0.35–0.40 (objective); NS (parent-rated) | Level 4 (Experimental) | Near-transfer only |
| Behavioral Parent Training | SMD 0.41–0.90 (observed/rated) | Level 1 (Well-Established) | Far-transfer confirmed |
| Behavioral Classroom Management | SMD 0.66–1.05 | Level 1 (Well-Established) | Far-transfer confirmed |
| Organizational Skills Training | g = 0.54–0.83 | Level 1 (Well-Established) | Far-transfer confirmed |
| CBT for Adult ADHD (Safren) | d = 1.19 vs. TAU | Level 2 (Strong Evidence) | Far-transfer confirmed |
| Standard Neurofeedback | Overall blinded SMD 0.04 (NS); standard-protocol subgroup SMD 0.21 | Not Recommended | Near-transfer only; indistinguishable from sham when properly blinded |
| CogMed (Working Memory Training) | Near: SMD 0.38–0.49; Far: SMD 0.12 (NS) | Not Recommended | Near-transfer only |
How EndeavorRx Compares to Other Computerized Interventions
| Feature | EndeavorRx | CogMed | Standard Neurofeedback |
|---|---|---|---|
| FDA authorization | Yes (De Novo) | No | No |
| Blinded RCT evidence | Yes (active control) | Yes (active control) | Yes (sham control) |
| Objective measure improvement | Yes (TOVA) | Yes (WM tasks) | Minimal (blinded) |
| Behavioral rating improvement | Not significant (standalone) | Not significant | Not significant (blinded) |
| Cost | ~$99/month out-of-pocket (pre-CMS codes) | $1,500–2,000+ | $3,000–5,000+ (30–40 sessions) |
| Session burden | 25 min/day × 5 days × 4 weeks | 30–45 min/day × 5 days × 5 weeks | 30–40 sessions over months |
| Evidence classification | Level 4 (Experimental) | Not Recommended | Not Recommended |
Key distinction: EndeavorRx has superior regulatory standing and a lower cost profile than neurofeedback and CogMed, but all three share the same fundamental limitation: improvements on trained or training-similar tasks that do not reliably transfer to real-world ADHD symptoms as rated by blinded observers.
Reimbursement and Access (2026)
| Factor | Detail |
|---|---|
| CMS G-Codes | The 2026 CMS Physician Fee Schedule introduced specific G-codes for digital therapeutics, creating a formal reimbursement pathway for the first time |
| Current out-of-pocket cost | ~$99/month |
| Insurance coverage | Variable; state-by-state Medicaid coverage decisions will determine whether low-income patients gain access |
| Equity concern | Without broad Medicaid coverage, DTx may become another intervention that widens the socioeconomic equity gap in ADHD care |
Consumer Apps: Adjuncts, Not Treatments
A growing market of non-FDA-authorized apps offer gamified habit-tracking, emotional regulation training, and organizational support. These include platforms like Joon, Mightier, and others.
| Feature | FDA-Authorized PDTs (EndeavorRx) | Consumer Wellness Apps |
|---|---|---|
| Regulatory review | FDA premarket authorization | None |
| RCT evidence for ADHD | Yes (blinded, controlled) | No peer-reviewed RCTs for core ADHD symptoms |
| Clinical recommendation | Can be discussed as adjunct | May be helpful as lifestyle supports — not treatments |
| Appropriate framing | "Adjunct to a treatment plan" | "Like a good planner or sleep hygiene routine" |
Emerging Pipeline
Akili (EndeavorRx Successor Platforms)
Akili has explored broader applications of the SSM Engine platform, including adult ADHD and other cognitive conditions. The evidence base beyond the pediatric indication remains limited.
Other Digital Platforms Under Investigation
Multiple companies are developing software-based attention training and executive function interventions. As of 2026, none have achieved FDA authorization for ADHD beyond EndeavorRx. Clinicians should apply the same evidence standards to new entrants: require blinded, controlled trial data showing far-transfer to behavioral outcomes before recommending them as treatments.
Clinical Decision Framework
When to Consider EndeavorRx
- As an adjunct to stimulant medication in children with residual attention difficulties
- When families request non-pharmacological additions to the treatment plan
- When medication alone produces partial response and behavioral interventions are already in place
When NOT to Recommend EndeavorRx
- As a replacement for medication in moderate-to-severe ADHD
- As a replacement for Tier 1 behavioral interventions (BPT, BCM, OST)
- When cost is a barrier and the family has limited resources — prioritize established treatments first
- When families are using it to avoid addressing medication ambivalence
How to Frame It for Families
"Think of it like physical therapy for attention. It exercises specific brain networks, and the evidence shows it improves attention test scores. It does not replace medication the way physical therapy does not replace a cast for a broken bone, but it may add something useful, especially for children who have residual attention difficulties on medication."
Opportunity Cost Consideration
Clinicians should explicitly communicate the opportunity cost calculus to families. The time and money spent on unproven digital interventions pursued instead of established treatments delays effective care during critical developmental windows. EndeavorRx at ~$99/month and 25 minutes/day represents a relatively low-burden addition; neurofeedback at $3,000–5,000+ and 30–40 sessions represents a high-burden substitution that produces comparable (negligible) behavioral improvement in blinded assessments. Families deserve this context to make informed decisions.
Summary Evidence Table
| Question | Answer |
|---|---|
| Does EndeavorRx improve objective attention measures? | Yes — modest effect (d ≈ 0.35–0.40) |
| Does it improve parent-rated ADHD symptoms? | Not as standalone; possibly as adjunct to medication |
| Is it a substitute for stimulant medication? | No — effect sizes are 2–3× smaller |
| Is it a substitute for behavioral therapy? | No — established behavioral interventions have larger effects with confirmed far-transfer |
| Is it safe? | Yes — mild adverse events only (frustration, headache) |
| Is it cost-effective? | Unclear — no formal cost-effectiveness analysis published |
| Current evidence level? | Level 4 (Experimental) per APA Division 53 criteria |
This quick reference tool is extracted from Module 5: Evidence-Based Psychosocial Interventions and Module 10: Disparities, Controversies & Emerging Directions. For full evidence review, comparison with other interventions, and complete references, see the full clinical modules.
For the full clinical curriculum, visit psychhq.com
Key References: Kollins et al. (2020) Lancet Digital Health; Kollins et al. (2021) npj Digital Medicine; FDA De Novo authorization DEN200026 (2020); Westwood et al. (2025) JAMA Psychiatry; Evans et al. (2014) J Clin Child Adolesc Psychol; Sonuga-Barke et al. (2013) Am J Psychiatry; CMS 2026 Physician Fee Schedule