Current Research Trends in Digital Therapeutic Tools for Mental Health

Introduction

As technology advances, so does our ability to identify and address various components of health. Digital therapeutics (DTx) are evidence-based digital tools designed to treat, manage, and prevent diseases, including numerous mental health disorders.^1,2 In contrast to general wellness applications (eg, exercise tracking software), DTx are clinically validated interventions that are either a prescription digital therapeutic or a nonprescription software-based treatment designed to address specific dimensions of disease.³ DTx hold transformative potential for supporting mental health care, offering scalable, personalized interventions that may improve patient quality of life.³ Early survey data of the experiences of people living with schizophrenia highlighted the potential for DTx to be accessible and usable for patients, even those with minimal prior experience with smartphones, but also demonstrated the patient-centered approach of DTx development through in-depth analysis of their feedback to identify gaps and needs.⁴  

Current Research Trends

Recent studies underscore the effectiveness of DTx in managing conditions like depression, attention-deficit hyperactivity disorder (ADHD), insomnia, post-traumatic stress disorder (PTSD), and substance use disorder (SUD), among others.² For example, a mobile-assisted cognitive-behavioral therapy, when used in conjunction with stable doses of pharmacotherapy (no hospitalization or medication change in the 4 months prior to study enrollment), showed improvement in the negative symptoms of schizophrenia (eg, depression, social withdrawal), with significant reductions in “defeatist” beliefs beginning by week 12 of a single-arm study that enrolled 31 patients with persistent negative symptoms of schizophrenia or schizoaffective disorder.⁵ Significant improvements in positive and negative symptoms were also noted in two assessment types at 24 weeks.⁵ However, the intervention did not significantly affect living, learning, working, and socializing goals.⁵ Additionally, data from another study evaluated the real-world 6-month impact of DTx on healthcare resource utilization in patients with SUD. This retrospective analysis of over 100 patients showed that DTx significantly reduced overall hospital encounters, including inpatient stays and emergency department visits.⁶ DTx continue to be investigated to supplement traditional psychiatric care, as they may broaden access, minimize hurdles, and reduce overall healthcare costs.^2,5,6 There are many avenues of potential opportunity, as the field of digital therapeutics includes web and mobile applications, virtual reality/video games, and other devices for several therapeutic areas, in addition to the potential for AI integration.²   

Challenges and Considerations

The US Food & Drug Administration (FDA) has authorized approximately 40 DTx platforms, 6 of which are indicated for mental health conditions. However, technical issues (eg, internet connectivity), lack of physician education and specific training, and patient concerns around privacy and data utilization are barriers to more widespread acceptance of this technology for mental health treatment.^7,8 DTx are regulated by the FDA as software as a medical device (SaMD), and they may undergo strict review to ensure clinical effectiveness and safety.³ Programs like the Pre-Cert program and the Digital Health Center of Excellence create FDA regulatory frameworks for different product types with the goal of improving transparency, clinical responsibility, authorization efficiency, and clear labeling for stakeholders.³  

Conclusion

DTx represent a promising advancement in managing mental health conditions, with certain DTx showing potential effectiveness in reducing some symptoms as an adjunct to pharmacotherapy and the potential to reduce healthcare utilization.^2,5,6 While they offer significant potential to enhance access and support traditional psychiatric care, technical issues, physician training, and patient privacy concerns must be addressed for broader acceptance.^7,8 Continued collaboration between DTx developers, healthcare professionals, and patients will be essential in overcoming these barriers and optimizing the benefits of these innovative tools in mental health treatment.

References:

1. Understanding DTx: a new category of medicine. Digital Therapeutics Alliance. Accessed March 3, 2025. https://dtxalliance.org/understanding-dtx/
2. Phan P, Mitragotri S, Zhao Z. Digital therapeutics in the clinic. Bioeng Transl Med. 2023;8(4):e10536. doi:10.1002/btm2.10536
3. Watson A, Chapman R, Shafai G, Maricich YA. FDA regulations and prescription digital therapeutics: evolving with the technologies they regulate. Front Digit Health. 2023;5:1086219. doi:10.3389/fdgth.2023.1086219
4. Ben-Zeev D, Kaiser SM, Brenner CJ, Begale M, Duffecy J, Mohr DC. Development and usability testing of FOCUS: a smartphone system for self-management of schizophrenia.Psychiatr Rehabil J. 2013;36(4):289-296. doi:10.1037/prj0000019
5. Granholm E, Holden J, Dwyer K, Mikhael T, Link P, Depp C. Mobile-assisted cognitive behavioral therapy for negative symptoms: open single-arm trial with schizophrenia patients. JMIR Ment Health. 2020;7(12):e24406. doi:10.2196/24406
6. Shah N, Velez FF, Colman S, et al. Real-world reductions in healthcare resource utilization over 6 months in patients with substance use disorders treated with a prescription digital therapeutic. Adv Ther. 2022;39(9):4146-4156. doi:10.1007/s12325-022-02215-0
7. Refolo P, Sacchini D, Raimondi C, Spagnolo AG. Ethics of digital therapeutics (DTx). Eur Rev Med Pharmacol Sci. 2022;26(18):6418-6423. doi:10.26355/eurrev_202209_29741
8. Woerner M, Sams N, Nales CR, et al. Generational perspectives on technology’s role in mental health care: a survey of adults with lived mental health experience. Front Digit Health. 2022;4:840169. doi:10.3389/fdgth.2022.840169

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