Within the shift from healthcare to holistic care, the mental health treatment value chain has reached an inflection point: The need for care is exponentially on the rise, but resources are faltering. The result is a growing vacuum of support for those struggling with mental health disorders.

In order to meet increasing care demand, healthcare practitioners and patients alike are turning to digital solutions to fill treatment gaps. More specifically, they’re leveraging digital therapeutics (DTx), which are gaining momentum and have applications across therapeutic areas.  

But, all DTx tools are not created equal.  

In this article, we explore the expanding role of digital therapeutics in mental health care, as well as the importance of the clinical substantiation of these tools for ensuring quality and effective patient care.  

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What are Digital Therapeutics (DTx)?

Digital therapeutics (DTx) are a subset of digital medical products. In the simplest terms, the DTx category includes software-based products—most often in the form of smartphone applications—used to prevent, manage, and treat health conditions. They may be used as a standalone alternative to monotherapy or to augment health outcomes in tandem with medicines, devices, or other treatments.  

According to a report published by Deloitte Insights, DTx will be one of “five forces” to reshape the biopharmaceutical industry in the next 20 years, disrupting traditional methods of patient care in favor of “[i]ncreasingly effective and scalable nonpharmaceutical (digital) interventions [that] … reduce or eliminate demand for medications.”  

Access to DTx can help patients make health decisions with greater agency while also enabling the prevention, early diagnosis, and management of health conditions. The FDA recognizes this potential and is subsequently encouraging DTx vendors to launch their platforms more quickly by loosening regulations surrounding the approval of digital mental health tools. Several reimbursement pathways are also in place to accelerate DTx adoption for patient care.

While the applications of DTx are relevant wherever most traditional pharmaceutical interventions leave a gap, mental health is emerging as a substantial interest area. Over the last few years, the lion’s share of DTx trials has been conducted within the central nervous system (CNS) therapeutic area, with special emphasis on psychiatric conditions.  

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Meeting the Vulnerabilities in Mental Health Care 

According to World Bank, nearly 1 billion people are currently living with at least one mental health disorder. Almost 75% of sufferers located in low-income countries are receiving no treatment.  

The discrepancy between care need and care access has only worsened in the wake of the pandemic. COVID-19 has disrupted or, in some cases, even halted mental health services in 93% of countries worldwide. Amidst rising health concerns and the consequences of social isolation, sufferers were—and continue to—seek out digital mediums to access mental health support.  

DTx offer an effective avenue for bridging gaps in access to mental health care by addressing vulnerabilities within the current care system. Leveraging DTx in patient treatment for mental health conditions provides a wealth of benefits, including:

• Mitigating the impact of mental health societal taboos by providing flexible and confidential routes to support
• Allowing patients to take an active role in their own care by managing and monitoring the pace of their treatment
• Improving health equity by expanding access to affordable mental health care
• Supporting the development of more effective clinical tools by increasing the range of collectable data from both individual patients and wider patient populations

As investors respond to rising demand and favorable regulatory developments, DTx treatments for mental health are—perhaps unsurprisingly—flooding the market. Pharma companies are now pouring funds into DTx development in an attempt to get ahead of the shift to digital solutions—so much so that experts from Insider Intelligence estimate DTx to be a $56 billion global opportunity by 2025.

But, even while these macro developments paint an optimistic picture for the expansion of treatment access, the growing availability of DTx mental health solutions solves only part of the problem.

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Ensuring the Efficacy of DTx Mental Health Therapies

When it comes to effective and accessible mental health treatment via DTx, more is not necessarily better. In their quality assessments of 614 DTx, experts from the Organisation for the Review of Care and Health Apps (ORCHA) discovered that 55.4% of digital health apps don’t meet quality thresholds and an even greater number—62.4% of apps tested—fall below clinical effectiveness requirements. Confronting such results, how can healthcare practitioners and patients ensure the safety, security, and efficacy of any DTx solution?

The answer is clinical substantiation.

Conducting robust clinical research in the form of clinical trials allows sponsors to gather data that validates the efficacy of their devices while ensuring patient safety and proper usage tracking within a monitored environment. The data collected throughout the study can objectively demonstrate whether or not a DTx is meeting quality thresholds and, most importantly, fulfilling its intended treatment purpose.  

In a market flooded with purported DTx treatment options, clinical substantiation serves as a vital source of differentiation—healthcare practitioners and, thus, their patients are far more likely to adopt a solution if it's backed by third-party research demonstrating efficacy.    

This is especially true for DTx sponsors seeking FDA approval, with the goal of introducing their solutions as functional components of clinical care. Despite the FDA’s acknowledgement of DTx as treatment pathways, the organization is still in the process of modernizing and adapting to properly evaluate and regulate digital products. The regulatory landscape for DTx is in flux—and even those digital therapeutics that meet existing guidelines may not adhere to consistently updating FDA approaches. As a result, it’s vital for DTx companies to leverage relationships with clinical research organizations not just for the purposes of gathering data but also to ensure their product(s) are meeting the FDA’s quality and efficacy thresholds and regulatory requirements.  

The Way Forward with DTx in Mental Health

There’s no denying that DTx have massive potential to provide some degree of balance to the uneven and inconsistent ways in which mental health support is accessed. Along with offering confidentiality—which is prioritized by many patients suffering from mental health conditions—these digital solutions often provide a more cost-effective and convenient route to support than would otherwise be available, especially in this post-pandemic context.

But, even as the market floods with more accessible solutions, it’s necessary to ensure that any DTx considered for treatment purposes can provide the quality care that patients need.