Have you ever heard the term digital therapeutics – or have any idea what digital therapeutics might be, and how they can help improve mental health treatment?
If you haven’t, don’t worry. They’re a new movement in mental health care that are becoming more popular every year. Now, think about something for us, or rather, consider this question:
How would you feel if your therapist wrote you a prescription for an app?
If you think this could never happen to you, you might want to think again.
On April 1, 2024, Otsuka Pharmaceuticals and Click Therapeutics announced that the U.S. Food and Drug Administration (FDA) had authorized a product called Rejoyn to treat depression.
This makes “the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adults.”
That’s a big deal.
While Reyjoyn may be first in this narrowly defined category, it is by no means the first digital therapeutic to have earned FDA approval for mental or behavioral health purposes.
According to a July 2023 report, the FDA previously approved or cleared 23 digital therapeutics, some designed to treat substance use disorders, a.k.a. addiction, and other mental or behavioral health disorders:
- Deprexis: psychosis, depression
- EndeaverRx: attention-deficit hyperactivity disorder (ADHD)
- Freespira: panic attacks, post-traumatic stress disorder (PTSD)
- NightWare: PTSD, insomnia
- ReSET and ReSET-O: substance use disorder (SUD)
- SparkRx: depression, focused on adolescents
- Vorvida: alcohol use disorder (AUD)
Developments in this space show no signs of slowing down. For example, in January, Click Therapeutics and the Boehringer Institute announced that the FDA granted “breakthrough device” designation to a prescription digital therapeutic the two companies developed jointly to treat negative symptoms among people who have schizophrenia.
Digital therapeutics may become a standard element of care for mental health disorders in the future. Before that can occur, advocates need to educate the public about their benefits and address concerns about issues such as data integrity, patient privacy, and accountability.
What Are Digital Therapeutics?
A June 2023 publication from the International Organization for Standardization (IOS) defined a digital therapeutic (DTx) as follows:
“A health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.”
In an attempt to promote more widespread understanding about these products, the Digital Therapeutics Alliance (DTA) offer this expanded definition:
- A DTx can be a standalone piece of software, or part of a system.
- Digital therapeutics may be accessible via a computer, tablet, or smartphone.
- A DTx may be incorporated into wearables such as smart watches, headsets, or sensors.
- Digital therapeutics can use patient and/or context-specific data to generate medical interventions when necessary.
- Products that claim to offer interventions, but that are not designed to treat disorders or alleviate symptoms, don’t qualify for the DTx designation.
Also, the DTA noted that the category of digital therapeutics includes both prescription and non-prescription products. Prescription digital therapeutics are sometimes referred to as PDTs.
Here are a few examples of what PDTs or other DTx products can look like in real-world scenarios:
- Apps that offer cognitive behavioral therapy (CBT) to individuals who have depression
- Wearable biofeedback devices that track and provides real-time responses to breathing patterns, which can help people with anxiety disorders
- Responsive video games that promotes focus, attention, and flexibility for young people who have ADHD
- Smart watch apps that track heart rate and movement patterns to disrupt nightmares and promote better sleep among people with PTSD
- Software programs that incorporate the principles of CBT and other modalities into modules and daily messages for people participating in medication-assisted treatment (MAT) for opioid use disorder (OUD)
The features and benefits of digital therapeutics will vary from one product to the next. Generally speaking, their benefits for individuals include portability, ease of use, personalization, and real-time feedback.
From a broader public health perspective, digital therapeutics can expand access to care, promote treatment compliance/adherence, and provide data-driven insights into the effectiveness of specific therapeutic approaches or techniques.
Do Digital Therapeutics Work?
In theory, digital therapeutics represent a landmark advancement in mental healthcare. But that’s theory, and patients need real-world data. Here are the important questions in need of answers:
What does the early data say about these products?
How well do they work?
What risks do they present?
What do mental health experts and professionals say about them?
The American Psychiatric Association (APA) cites the following benefits of digital therapeutics:
- Potentially safer alternatives to in-patient care in some circumstances, such as during an epidemic or pandemic.
- Potentially more cost-effective than other, more traditional, interventions.
- May reduce time healthcare providers spend on non-care tasks, potentially creating more time for care-related tasks
- May be effective across various demographic groups and in multiple sociocultural contexts.
Digital therapeutics are relatively recent additions to the mental healthcare space. Therefore, decades of data don’t exist like they do for many medications and types of therapy.
Research is an essential part of the development process for digital therapeutics, and the FDA requires manufacturers to prove the safety and effectiveness of any new product before approval or clearance. While some performance information does exist, Dtx products have simply not been around long enough for researchers to understand the long-term effects of PDTs or non-prescription DTxs.
Here’s what Otsuka Pharmaceuticals revealed about the testing that led to the FDA clearance of Rejoyn:
- The FDA based its decision in part on data from a remote double-blinded control trial involving 386 participants.
- Study participants were 22-64, diagnosed with major depressive disorder, and on antidepressant medication.
- During the trial, participants used Rejoyn or a sham control app for six weeks.
- Participants whose treatment involved Rejoyn showed improvements in symptom severity on three separate evidence-based depression assessments
- One month after the trial, participants in the Rejoyn group showed “continued improvement” and an absence of negative side effects.
The reliability of test results depend on the quality of the test itself, which leads to the question:
Do research efforts in the DTx sector merit confidence?
Here’s what a March 2024 review of 449 published studies on digital therapeutics found:
- Most DTx trials are sponsored by academic institutions or private companies with few collaborators.
- DTx trials are typically short, with the average research effort lasting about one year.
- Though short, some DTx trials have involved up to 400,000 participants.
- Few studies conducted in socioeconomically disadvantaged areas, and most excluded pregnant patients, patients with co-occurring disorders, or patients not fluent in English.
To promote industry-wide conventions for assessing the quality of digital therapeutics in mental health treatment, an international group of health experts proposed a standardized framework that encompasses designing, developing, testing, and monitoring.
This group described its real-world evidence (RWE) framework as follows:
“…a pragmatic, iterative, milestone-driven approach … [that will] ensure the highest level of fidelity to the needs of users.”
What Are the Drawbacks of Digital Therapeutics in Mental Health Treatment?
Digital therapeutics appear to pose minimal risk of side effects. The existing research shows they can be beneficial.
However, this doesn’t mean that no one has raised concerns about their use.
An August 2022 article in the journal Frontiers in Psychiatry identified high attrition and low engagement as possible areas of concern among DTx users.
These two concerns both involve how likely people are to continue using the products. Attrition refers to study participants who drop out before a trial ends, while engagement focuses on the likelihood that patients will complete full courses of treatment.
Here’s what the authors of the August 2022 article wrote about attrition and digital therapeutics:
“In virtual platform trials of digital therapeutics, compliance cannot simply be measured by the number of times a subject logs on to an app, and it is important to also measure and report how engaged users were with the app. Currently, there is no standard way to define what constitutes meaningful engagement and how to compare engagement across different digital therapeutic devices.”
To support their concerns, they noted:
- In a study on cognitive behavioral therapy for depression, only about 11% showed a high level of engagement.
- A 2020 meta-analysis of 18 randomized trials involving mobile apps for treating depression showed:
- 26.2% dropout rate
- When adjusted for publication bias, the same study showed:
- 47.8% dropout rate
- A study of 93 apps that focused on mental well-being found:
- Daily active user rate: 4%
- 15-day retention rate: 3.9%.
Here’s how the study authors characterize these results:
“Mental health conditions, like major depressive disorder, ADHD, and PTSD, require sustained treatment. If even well-designed, gamified, digital therapeutics have a 50% drop in engagement in three months then the outlook for long-term efficacy is grim.”
Other observers cite data integrity and privacy as potential problems for patients and caregivers.
The European Data Protection Supervisor lists the following concerns about protecting the information of patients who use digital therapeutics:
- A vast amount of personal data is collected directly from the patient and processed in a complex digital ecosystem. This practice might entail risks of being constantly observed or the possibility of repurposing patient profiles.
- Considering the sensitivity and amount of personal data processed within DTx applications, a potential data breach can be a significant risk for the person concerned.
- The fact that the processing requires compatibility with numerous operating systems and app providers, risks related unlawful access across devices and providers due to possible security flaws are a significant concern.
In summary, questions regarding the safety of Dtx include:
- Identity theft
- Illegal access to data
- Unapproved identity disclosure
- Data corruption
- Data loss
These are very real concerns that we can all easily understand. We know our personal information is now a commodity and encounter this new fact every time we accept cookies or confirm our preferences on websites we visit.
Are Digital Therapeutics the Right Mental Health Treatment for You?
No medication, type of therapy, or course of treatment is one hundred percent effective or appropriate for everyone with a certain disorder or condition. While digital therapeutics currently show great promise for expanding access to care – and delivering more personalized services – the likelihood is that they will help some people and not help others.
The best way to determine if digital therapeutics or any other services are right for you is to consult with a qualified healthcare provider. This professional can assess your needs, diagnose the cause of your symptoms, and recommend appropriate treatment options.
Remember: There is no such thing as a perfect treatment technique or service. The best caregivers focus on collaborating with you to find the elements of care that work best for you. Whether best for you includes digital therapeutics is for you and your provider to decide.
Gianna Melendez
Jodie Dahl, CpHT