Prescription Digital Therapeutics for Mental Health: A New Era in Psychiatry

The recent proliferation of prescription digital therapeutics for mental health disorders represents a transformative shift in psychiatric care. Although these products aim to leverage technology to increase patient accessibility to evidence-based treatment, many experts have raised concerns over patient information protections, the gamification of psychiatry, and the logistics of this new form of therapy.

Herein, we provide an overview of prescription digital therapeutics currently cleared by the United States Food and Drug Administration (FDA) and highlight clinician perspectives on navigating this evolving intersection of technology and mental health care.

FDA Approved Prescription Digital Therapeutics for Mental Health

DaylightRx: Generalized Anxiety Disorder

On September 4, 2024, the FDA cleared DaylightRx for the treatment of generalized anxiety disorder (GAD) among patients aged 22 years and older.¹

The app-based digital therapeutic is a 90-day treatment that provides users with cognitive behavioral therapy (CBT) via interactive lessons on cognitive restructuring, applied relaxation, and stimulus control.

Rejoyn™: Major Depressive Disorder

On April 1, 2024, the FDA approved Rejoyn — a prescription smartphone app-based digital therapeutic — as an adjunct to clinician-managed outpatient care for the treatment of major depressive disorder (MDD) among adults aged 22 years or older.² Rejoyn is the first digital therapeutic authorized by the FDA to treat MDD.

The Rejoyn program includes a combination of the Emotional Faces Memory Task (EFMT) exercises and brief cognitive behavioral therapy (CBT)-based lessons, along with text messaging to reinforce content and encourage engagement.³

“As a clinician, I’m excited that this app is now a treatment option for my patients due to its affordability and accessibility, with no contraindications or side effects observed in the clinical trial,” said psychotherapist Saundra Jain, MA, PsyD, LPC, adjunct clinical affiliate for the School of Nursing at the University of Texas at Austin.

“The cognitive emotional training exercises are designed to simultaneously activate the amygdala and prefrontal cortex,” Dr Jain explained.³ “This can help strengthen the connection between these 2 areas, thus improving how the brain processes thoughts and emotions, which may lead to a reduction in depression symptoms.”

MamaLift Plus^TM: Postpartum Depression

On April 23, 2024, the FDA approved MamaLift Plus as the first prescription digital therapeutic for the symptomatic treatment of mild to moderate postpartum depression (PPD) among patients aged 22 years and older.⁴ 

MamaLift Plus is a neurobehavioral intervention that uses elements of CBT, dialectical behavior therapy (DBT), behavioral activation therapy (BAT), and interpersonal therapy (IPT). The therapeutic is intended as an adjunct to clinician-managed outpatient care.

CT-155: Schizophrenia

In January 2024, Click Therapeutics, Inc received FDA breakthrough device designation for CT-155, their investigational prescription digital therapeutic. CT-155 uses psychosocial intervention techniques to treat negative symptoms among adults with schizophrenia.⁵

NightWare: Sleep Disturbance

NightWare – a prescription digital therapeutic designed to reduce sleep disturbance among adults aged 22 years and older with nightmare disorder or post-traumatic stress disorder (PTSD) – received FDA authorization in November 2020.⁶ NightWare analyzes changes in heart rate and body movement during sleep (using a smartwatch and sensors) and delivers gentle vibratory stimulation to abort nightmares.  

EndeavorRx: ADHD

EndeavorRx is a video-game-based intervention intended to improve attention among children aged 8 to 17 years with primarily inattentive or combined-type attention-deficit/hyperactivity disorder (ADHD), as part of a therapeutic treatment plan.⁷ Endeavor Rx received FDA approval in June 2020.

reSET and reSET-O: Substance Use Disorder, Opioid Use Disorder

The reSET and reSET-O are indicated for the treatment of substance use disorder and opioid use disorder and received FDA clearance in 2017 and 2018, respectively.^8,9

The company that originally developed the apps, Pear Therapeutics, filed for bankruptcy and ceased business operations in 2023, casting uncertainty on the future of these digital therapeutics. However, PursueCare acquired reSET and reSET-O and resumed service in August 2024.¹⁰

Protecting Patient Information  

Although the FDA approved these prescription digital therapeutics, patient privacy issues and the protection of sensitive information are ongoing concerns in the digital health care space. “Protecting patient information is critical with apps like these, and it is up to companies that make these medical devices to implement robust safeguards to ensure that sensitive patient information is secure,” Dr Jain emphasized.

With Rejoyn, for example, the “consents are written in plain language and allow users to opt-in for things like sharing their data with Rejoyn nurses for treatment support,” and patients can change their privacy choices in the app at any time, she continued.¹¹

Generally, however, patients who use digital therapeutics “are putting their data in the hands of these companies, and some have a good track record of privacy while others don’t,” according to John Torous, MD, MBI, director of the digital psychiatry division at Beth Israel Deaconess Medical Center and assistant professor of psychiatry at Harvard Medical School in Boston.

While the apps are required to adhere to Health Insurance Portability and Accountability Act (HIPAA) rules and other privacy regulations, the Federal Trade Commission recently “settled with 2 digital mental health companies for privacy violations, highlighting that the privacy status of the entire space remains less than ideal,” he said.¹²

Potential Barriers and Final Perspectives

The widespread adoption of prescription digital therapeutics is substantially limited by disparities in reliable access to broadband and high-quality digital devices among patients¹³ and variable insurance coverage. However, some applications can be offered at a discounted rate for patients paying out-of-pocket.¹⁴ “Coverage from healthcare insurers is imperative for wider use and the success of these treatments,” Dr Jain said.

Another major barrier to this new frontier in mental health care is the lack of physician awareness and education about integrating digital options into clinical practice, she added.

“Every FDA-approved app I have seen needs to be used under the direction of a physician, and many psychiatrists are unsure whether to prescribe these, as they are unsure if the apps actually work well enough to make a difference for the patients they treat,” Dr Torous explained. “Most clinicians are interested to learn more but so far have been underwhelmed by the evidence regarding these digital therapeutics.”

He noted that digital therapeutics are FDA-authorized as medical devices, and the evidence required by the FDA for authorization of these devices is often less rigorous than the evidence required for medication approval.“Finally, with thousands of non-prescription apps accessible today and many of them with perhaps stronger evidence than FDA-cleared ones, there is currently little need for clinicians to prescribe these,” Dr Torous said.

However, Dr Jain believes that clinicians will ultimately embrace the integration of digital therapeutics into practice, given their favorable safety profile and potential for symptom reduction in some patients. “Digital therapeutics are enhancing mental health care by providing accessible new treatment options that complement, rather than compete with, traditional therapies,” she stated.

This article originally appeared on Psychiatry Advisor