In the U.S., 23% of adults—nearly 60 million Americans—reported experiencing a mental illness in the past year, yet over half (54.7%) did not receive treatment (1, 2). Complex environmental and social factors contribute to this shortfall, and certain communities experience inequitable impacts (3). This includes the 20% of Americans living in rural areas, who often face gaping disparities in mental healthcare access stemming from a milieu of infrastructural and sociocultural factors (4–6). Sixty-five percent and 47% of rural counties lack a resident psychiatrist and psychologist, respectively, compared to 27% and 19% of metropolitan counties (7). Securing transportation to this physically distant care may be especially burdensome for those who lack public transit or depend on others for their transportation (8). Even telemedicine remains unfeasible for some rural areas, where broadband may be limited or entirely unavailable (9–12).

Financial factors like lower socioeconomic status, higher unemployment, higher utilization of public health insurance, or lack of insurance altogether further impede rural mental healthcare access (10, 13, 14). These elements translate to reduced access to health information which deters appropriate and effective mental healthcare (15). In parallel, rural sociocultural influences—such as expectations of self-reliance, stigma associated with mental health, and less privacy in smaller communities—function as individual-level deterrents to seeking care (6, 16–18). Low treatment rates and poor care management as a result of these cultural influences and resource constraints point to the inadequacy of current modalities and a need for innovative alternatives that diversify care for rural communities (6, 19).

One proposed solution is Prescription Digital Therapeutics (PDTs): remote, software-based treatments that deliver clinically validated therapies on devices like smartphones or tablets (20). Unlike direct-to-consumer digital health apps, PDTs must be 1. tested in clinical trials, 2. reviewed by a regulatory body [e.g., the United States Food and Drug Administration (FDA)] for efficacy and safety, and 3. prescribed by a healthcare provider (21). Currently, the FDA has cleared over 20 PDTs targeting a variety of conditions like irritable bowel syndrome, chronic lower back pain, and diabetes (22, 23).

Mental health is an especially promising application for PDTs given the demonstrated efficacy in this area, clear regulatory pathways, and opportunity to alleviate provider-patient imbalances (21, 24). Used independently or in combination with pharmacotherapy or cognitive-behavioral therapy, mental health PDTs are designed to provide evidence-based treatment in a convenient, user-friendly, and personalized format. Their scalability and ability to reduce in-person provider visits could offset treatment costs, while continuous monitoring and outcomes tracking may streamline care (22, 25). In this way, PDTs could be especially useful for rural populations who might benefit from fewer in-person interactions and additional support between appointments (3, 26, 27). With rigorous data and privacy standards in place, the option to be treated anonymously in one's own home may mitigate rural undertreatment stemming from mental health stigma (26).

However, similar to telemedicine, PDTs that depend on smartphone use or internet connectivity may be less feasible for users in “digital deserts,” where broadband is limited or unavailable (28–30). In conjunction, lower digital literacy might hamper interest among historically disadvantaged groups or compromise effective engagement once prescribed (28). Privacy and data security concerns also hinder willingness to use PDTs, particularly among populations with intergenerational distrust of the medical system (29). Ensuring that digitization mitigates, rather than exacerbates, health disparities requires thorough consideration of the factors shaping access to care. Quantitative and qualitative studies have evaluated such barriers and facilitators to digital mental health use; however, these generally probed on a wide scope of interventions (e.g., general “health apps” or telemedicine) rather than FDA-cleared and physician-prescribed therapeutics (31, 32). Both features could serve as impactful drivers of value, necessitating evaluation both separately and within the context of broader digital health benefits (33, 34).

In addition, few studies have considered the impact of rurality on the perceived utility of PDTs, despite its clear ties to both mental health treatment and digital access (35). One exception is a study by Jongebloed et al., which identified strong rural engagement with digital health products in Australia, however, findings were limited by the sample's high baseline digital literacy (36). A second, more applicable example involved a small qualitative survey of U.S. veterans (n = 66), which observed an overall lack of awareness about “mental health smartphone apps” and lower receptivity among rural veterans (37).

In developing a quantitative approach, ex-U.S. studies comprised the most informative research for this purpose, likely owing to the enhanced integration of PDTs into mainstream care via centralized market access and reimbursement frameworks (38). A study in two German academic centers surveyed urology patients to assess age-based differences in the use of digital therapeutics and valued product qualities (39). Another German study evaluated use, adherence, acceptance, and perceived PDT efficacy among a small sample of rheumatology patients (40). While these were not specific to mental health or rurality, the statistical analyses performed in these studies serves as an illustrative precedent.

To optimize capture of the lived experience and prioritize the interests of those directly impacted by this research, a diverse group of mental health advocates and digital health experts provided input on the study's design and interpretation. Drawing from these advising co-authors' recommendations and the existing literature, we developed the first quantitative, U.S.-based study that 1. focused on mental health and existing barriers to care, 2. probed perceptions of PDTs specifically, rather than digital health more broadly, and 3. meaningfully explored the impact of community setting on PDT receptivity (31, 32). The objective of this research was to apply an advocacy-led, people-centered approach (i.e., focused on the priorities and needs of those affected by the research) to evaluate differences in the treatment experiences of rural and non-rural (i.e., urban and suburban) people living with a mental health condition and the perceived utility of PDTs across settings (41). Understanding these community-level differences will likely be critical for integrating PDTs into treatment decision-making.

In this study of 351 U.S. adults living with a mental health condition, clear barriers to adequate mental healthcare and high interest in PDTs were observed across community types. The results of this advocacy-led, person-centered survey demonstrate that PDTs are a promising new therapeutic option with the potential to overcome the diverse factors impeding treatment access, particularly those impacting rural communities. Though elements of this study's sample and methods—namely, digital access bias and rurality self-reporting—may limit generalizability to broader real-world contexts, the findings offer important insights with implications for future research and clinical practice.

While community-agnostic barriers like finding transportation, lacking time, and trouble affording care were widely experienced, rural respondents faced the added challenges of longer distances to care, lower incomes, less formal education, and high reliance on Medicaid in alignment with prior literature (13, 59–61). These widely recognized social determinants of mental healthcare access and quality represent a collective and intersectional burden for rural communities who might uniquely benefit from the time and resources saved with remote treatment options (6, 63).

Despite the need for remote therapies, rural respondents were significantly less likely to have used any digital app or device for their physical or mental health and were less likely to be familiar with digital apps for mental health treatment, echoing prior findings of lower mental health app utilization in rural vs. urban populations (35, 37). This divide in awareness and adoption may reflect limited access to traditional mental healthcare, since most respondents who used digital health apps were introduced to them by their providers (6). Consequently, facilitating access to prescribing physicians will be critical for rural people with mental health conditions to benefit as much as their non-rural counterparts, especially for prescription-only PDTs. Facilitation could entail efforts to scale up telehealth and other digital care interfaces alongside culturally relevant PDT awareness campaigns for providers and people living with a mental health condition (64, 65). Though broadband access and adoption in rural communities is still below that of non-rural communities, recent 5-year data indicates that broadband use has been increasing among rural people of all ages, presenting a critical opportunity for digital physician interactions and PDT use to grow in parallel (10).

This study was unique in that it specifically probed on potential users' perceptions of the differentiating features of PDTs: FDA clearance and prescription by a physician. Respondents had higher trust in an app with FDA clearance, viewing this as an indicator of safety and efficacy. “Trust” has been shown to be a key facilitator of digital app use, contextualizing the importance of this finding (36). FDA clearance was also considered “Important” alongside being recommended, prescribed, or ordered by a mental health provider, reinforcing the physician's role as a key intermediary, as detailed elsewhere (64, 65). Though clinician sentiment was not within the scope of this study, additional research should assess whether rural mental health providers' awareness, reservations, or levels of interest surrounding PDTs are aligned with those of rural people living with mental health conditions. Survey respondents also highly valued safety and efficacy, signaling the need for providers to communicate the robust clinical standards that distinguish PDTs from other digital health tools (25).

In contrast to prior research identifying negative sentiment towards mental health apps among rural communities (37), rural and non-rural respondents in our survey were equally excited about the prospect of PDTs. Frequent engagement among the 55% of respondents already using apps suggests they are well-received and helpful to those who have access. Further, rural and non-rural respondents' acknowledgement of PDTs' ability to overcome a variety of existing barriers implies that PDTs could address unmet needs in ways that are meaningful to users. Longitudinal and behavioral data are needed to confirm these interpretations, and future research might consider exploring whether interest in PDTs correlates with actual adoption, as well as whether PDT use improves long-term access to care, treatment satisfaction, and mental health outcomes.

This study has several limitations, primarily the online nature of the survey and the use of an elective surveying service, which potentially skewed recruitment towards individuals with at least some level of internet access, greater digital literacy, and a higher likelihood of using PDTs. This may also explain why technical difficulties were the least frequently reported barrier. Future research should leverage traditional surveying methods and a sample with low digital literacy to deeply explore whether factors like smartphone ownership, perceived ease of use, and broadband access alters receptivity among the rural population. Preference for a care-seeking population also likely skewed the sample towards those generally being more open to treatment whether through traditional or non-traditional means.

Although community type was defined with recognizable, plain-language definitions, self-reported rurality is another inherent limitation due to potential social desirability bias or misinterpretation by the respondent. This may have impacted the representativeness of the rural and non-rural groups, and future research could use alternative metrics for rurality or link individual survey data with zip codes to verify rurality. The connection between rurality and other social determinants of health may have also been a confounding factor for the observed rural/non-rural differences. Future studies and analyses could further explore the interplay between rurality and specific social determinants of health (e.g., income and education) on access barriers and perspectives towards PDTs (13, 59–61).

The predominately white rural sample was not adequately representative of all races and ethnicities, which may limit generalizability and restrict capture of the intersectional challenges experienced by disparate groups within the rural community. The representativeness of the broader sample relative to the United States as a whole is another limitation, given potential geographic differences in payer coverage of mental healthcare, quality of care, and access to care.

To minimize respondent burden, the facilitators and barriers explored were by no means exhaustive, and additional value drivers not included in this study have been evaluated elsewhere (31, 35). Note, the study was not designed for preference testing of the most important PDT features, which will be an important area for future research. Specifically, due to the complexity of coverage and pricing, particularly with different insurance types, this research did not focus on out-of-pocket costs, which could be a key driver of real-world use (31). Additionally, this person-centered approach captured potential end-users' perspectives in isolation from the abundant policy and reimbursement hurdles that currently complicate PDT uptake (21). As such, high interest in PDTs among our sample does not guarantee real-world adoption, but it does support deeper consideration of the contextual factors shaping PDT uptake. These include coverage across various insurance types; education, treatment planning, and workflow management among providers; as well as the availability of culturally sensitive resources that enhance awareness of PDTs, particularly in rural areas (26, 31, 66, 67). More broadly, campaigns to expand the availability and affordability of internet access alongside digital literacy will be critical to facilitating equitable PDT uptake, particularly in rural areas (26, 31). In light of these variables, important complements to this and future research are published implementation science studies and related frameworks for integrating digital therapies into routine care (15, 68–74). Rural-specific applications of such approaches should be explored in detail for PDTs.

In conclusion, this first-of-its-kind study identified persistent gaps in mental healthcare and gauged interest in PDTs among potential users. Rural respondents faced worse social determinants of health and the added barrier of greater distances to care. Although familiarity with digital health was low, particularly among rural individuals, high interest in FDA-cleared, physician prescribed mental health apps across community types indicates strong receptivity to mental health PDTs. Explicit recognition of this new modality's capacity to overcome treatment barriers underscores the potential for PDTs to democratize care and transcend the infrastructural, environmental, and sociocultural challenges facing underserved rural communities.