Swipe Right on Wellness: The Rise of Digital Therapeutics in Mental Health

Drug Topics JournalDrug Topics April 2024
Volume 168
Issue 03

Digital therapeutics are positioned as front-runners in the increasingly digital future of health care.

Although their excessive use is often linked to negative health outcomes such as depression and anxiety, smartphones could be exactly what the doctor ordered.

Person holding tablet with health care icons / Production Perig - stock.adobe.com

Person holding tablet with health care icons / Production Perig - stock.adobe.com

That’s the promise of digital therapeutics, which aim to turn smartphones into personalized health care companions with evidence-based apps and programs that address the behavioral dimensions of many diseases and conditions.1 Unlike other health and wellness apps, digital therapeutics are vetted through the FDA’s medical review pathways and are clinically proven to be safe and effective for users.

GlobalData forecasts the digital therapeutics market will grow by 25% annually between 2022 and 2030, underlining its emergence as a front-runner in an increasingly digital future of health care.2 By providing more discreet and personalized care options, expanding access, and addressing provider shortages, digital therapeutics are redefining the treatment landscape for the more than 1 in 5 Americans with a mental illness,3 including those with substance use disorder (SUD), posttraumatic stress disorder (PTSD), and attention-deficit/hyperactivity disorder (ADHD).

Substance Use Disorder

The US was already grappling with an SUD epidemic before the COVID-19 pandemic. Factors associated with the public health emergency, such as widespread isolation and increased mental health burden, inflated this epidemic even further.4

Today, more people need treatment for SUD than there are resources available to provide it. Even for eligible individuals, barriers to access, stigma, and high costs paint a poor picture of substance use disorder care. In 2020, it was reported that most of the estimated 40.3 million people 12 years or older who had substance use disorder in 2020 did not receive substance abuse or mental health treatment.4

To address this treatment gap, Pear Therapeutics released reSET, approved in 2018 as the first FDA-cleared prescription digital therapeutic for SUD.5 The mobile app, designed to be used in conjunction with outpatient clinician-delivered care, takes a community reinforcement approach to deliver therapy in a prescription duration of 12 weeks. It offers users 62 interactive modules—32 core and 30 supplemental—to promote skill building that supports behavior change and prevents relapse.6 Furthermore, reSET empowers clinicians with a built-in dashboard to track patient-reported data, fostering richer patient-clinician interactions. In findings from a clinical study, adding reSET to outpatient therapy for patients whose primary addiction was not opioids increased abstinence rates by more than 20%.6 Following the success of reSET, Pear Therapeutics developed reSET-O, another mobile app specifically designed to combat the opioid use epidemic.

App users were frustrated when they lost access to the digital products after Pear Therapeutics filed for bankruptcy in April 2023. By December 2023, reSET and reSET-O were both acquired by PursueCare, a provider of virtual SUD care.7


Similar to treating patients with SUD, treating patients with PTSD poses its own challenges. Two common treatments include exposure-based psychotherapeutic methods, which often require patients to revisit traumatic memories, and medication, which may have adverse effects.8 Freespira, approved in 2018 as the only FDA-cleared, evidence-based, medication-free digital therapeutic, overcomes these issues to treat the underlying physiologic mechanisms of panic attacks and PTSD.

“PTSD is extremely difficult to treat,” principal investigator Michael Ostacher, MD, MPH, MMSc, a professor of psychiatry and behavioral sciences at Stanford University, said in a news release.8 “The availability of an effective, 4-week drug-free intervention is a game changer for people [experiencing] PTSD. Freespira offers hope for people who otherwise experience a significantly diminished quality of life.”

Using a proprietary sensor that measures real-time CO2 and respiratory rate, a mobile companion app, and coaching, Freespira works to correct patients’ respiratory patterns over the course of 28 days.9 The program reduces the likelihood of panic attacks and PTSD symptoms by improving breathing dysfunction associated with hypersensitivity to CO2. In findings from a clinical study assessing the effectiveness of Freespira, 50% of patients no longer met the diagnostic criteria for PTSD and sustained remission of PTSD until at least 6 months post treatment with the product.8


Digital therapeutics have also emerged as a promising way to address mental health conditions in children. Although medication and behavioral therapy are the usual first steps to manage ADHD, the makers of EndeavorRx, the first prescription treatment delivered through a mobile video game, sought to introduce a new approach for helping children aged 8 to 12 years with the condition.

“With EndeavorRx, we’re using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment,” Eddie Martucci, PhD, CEO of Akili, the parent company of EndeavorRx, said in a news release.9

Cleared by the FDA in 2020,10 children using the app must exercise focus and flexibility to complete a course while collecting targets and avoiding obstacles in an action video game experience. This allows for second-by-second monitoring of patient progress while smart algorithms personalize the experience to keep users engaged and adherent.11

In a move that is expected to more than double the number of pediatric patients with ADHD who are now eligible for EndeavorRx, the FDA recently expanded its EndeavorRx approval to include individuals aged 13 to 17 years.12 Almost 30% of participants demonstrated at least a 30% reduction in total scores on the ADHD Rating Scale in findings from a clinical study that supported the expansion.12

Challenges in Digital Therapeutics

Despite the exciting possibilities and demonstrated benefits associated with digital therapeutics, some challenges regarding their adoption in the clinical space remain. First, they require that patients own and know how to operate a smartphone or smart device—an inequity that disproportionately affects older and lower-income adults.4 Access is further restricted by insurance policies; most breakthrough digital therapeutics are ineligible for coverage under Medicare.1 Unfamiliarity with digital therapeutics due to limited training may make clinicians hesitant to prescribe them to patients.4

As digital therapeutics continue to be integrated into the clinical space and recommended for mental health conditions such as SUD, PTSD, and ADHD, ensuring accessibility must be a top priority. Only then can the full potential of these technologies be unlocked.

READ MORE: Mental and Behavioral Health Resource Center

1. Miao BY, Arneson D, Wang M, Butte AJ. Open challenges in developing digital therapeutics in the United States. PLOS Digit Health. 2022;1(1):e0000008.doi:10.1371/journal.pdig.0000008
2. About mental health. CDC. Updated April 25, 2023. Accessed March 5, 2024. https://www.cdc.gov/mentalhealth/learn/index.htm
3. US digital therapeutics market to grow at 25% CAGR from 2022 to 2030. News release. MedicalDevice Network. February 21, 2024. Accessed March 5, 2024. https://www.medicaldevice-network.com/news/us-digital-therapeutics-market-to-grow-at-25-cagr-from-2022-to-2030
4. Brezing CA, Brixner DI. The rise of prescription digital therapeutics in behavioral health. Adv Ther. 2022;39(12):5301-5306. doi:10.1007/s12325-022-02320-0
5. Sandoz and Pear Therapeutics announce launch of reSET for treatment of patients with substance use disorder. News release. Novartis. November 20, 2018. Accessed March 5, 2024. https://www.novartis.com/news/media-releases/sandoz-and-pear-therapeutics-announce-launch-reset-treatment-patients-substance-use-disorder
6. reSET. Digital Therapeutics Alliance. Accessed March 5, 2024. https://dtxalliance.org/products/reset/
7. Gonzalez M. Addiction startup PursueCare raises $20M, acquires Pear Therapeutics’ tech. Behavioral Health Business. December 13, 2023. Accessed March 14, 2024. https://bhbusiness.com/2023/12/13/addiction-startup-pursuecare-raises-20m-acquires-pear-therapeutics-tech/
8. Palo Alto Health Sciences obtains FDA-clearance for Freespira in treating post-traumatic stress disorder. News release. Freespira. December 18, 2018. Accessed March 5, 2024. https://freespira.com/press/palo-alto-health-sciences-obtains-fda-clearance-for-freespira-in-treating-post-traumatic-stress-disorder
9. Freespira. Digital Therapeutics Alliance. Accessed March 5, 2024. https://dtxalliance.org/products/freespira/
10. FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD. News release. FDA. June 15, 2020. Accessed March 5, 2024. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd
11. Akili announces FDA clearance of EndeavorRx for children with ADHD, the first prescription treatment delivered through a video game. News release. Akili. June 15, 2020. Accessed March 5, 2024. https://www.akiliinteractive.com/news-collection/akili-announces-endeavortm-attention-treatment-is-now-available-for-children-with-attention-deficit-hyperactivity-disorder-adhd-al3pw
12. EndeavorRx, world’s first and only prescription video game treatment, secures FDA label expansion for pediatric ADHD patients aged 13-17. News release. Akili. December 18, 2023. Accessed March 5, 2024. https://www.businesswire.com/news/home/20231218891755/en/EndeavorRx%E2%93%87-World%E2%80%99s-First-and-Only-Prescription-Video-Game-Treatment-Secures-FDA-Label-Expansion-for-Pediatric-ADHD-Patients-Aged-13-17
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