In May 2024, the Food and Drug Administration approved the first app for the treatment of depression, Rejoyn. This new smartphone app is intended to help treat people who don’t fully respond to antidepressants and it is expected to be available for patients starting this summer. This is the latest in a series of FDA approvals of digital therapeutics for mental health conditions. (Read more in Psychiatric News.)

What Are Digital Therapeutics?

Digital therapeutics for mental health are health software that can be accessed on a phone, a tablet or a computer. They deliver evidence-based and validated putics are a subset of the broader category of digital health interventions which includes numerous mental health-related apps. The effectiveness of these apps may not be supported by research. Digital therapeutics:

• Are health software intended to treat or alleviate a disease, disorder, condition, or injury..
• Provide a medical intervention that has scientific and clinical evidence of a positive therapeutic impact on a patient’s health..
• May be used independently or in concert with medications, devices, or other therapies..
• May or may not require a prescription. • Are generally considered medical devices subject to regulatory oversight by the Food and Drug Administration.

(Adapted from SAMHSA 2023)

Prescription digital therapeutics are a further subset that have been cleared or approved for prescription use by the FDA as software-based medical devices intended to prevent, manage, or treat a medical or mental health condition.

Using the Apps

For the Rejoyn app, once it’s prescribed by a clinician, the patient will download it on their smartphone. They will then work through a six-week program of lessons and exercises, which involves alternating cognitive behavioral therapy-based lessons and emotional faces memory task exercises (designed to enhance emotional information processing). It also provides personalized reminders and messaging. The individual will have access to the materials for an additional four weeks after the program is finished.

Another example is the EndeavorRx app, which the FDA cleared several years ago for the treatment of attention-deficit/hyperactivity disorder. EndeavorRx is available by prescription to treat children ages 8 to 12 with primarily inattentive or combined-type ADHD. The app is accessed on a mobile device and involves the child participating in a video game-based experience, typically for 25 minutes a day five days a week. The user is presented with sensory stimuli and challenged to multitask and ignore distractions. One recent study found that parents reported improvements in ADHD symptoms after two months. EndeavorRx is intended to be used in addition to other treatment and is not a substitute for ADHD medication.

A number of alternative approaches for digital treatment of ADHD are being researched and explored. (Read more in Psychiatric News.) Among the other FDA-cleared prescription digital therapeutics are apps intended to: treat PTSD, panic disorder, panic attacks; treat substance use disorder; and treat chronic insomnia (SAMHSA).

While digital therapeutics can offer many advantages, including convenience and access, they are not intended to replace the work of mental health professionals and they may not be appropriate or preferred. There are also challenges relating to insurance coverage for use of digital therapeutics and their accessibility, privacy/security, and research and evidence on longer-term effectiveness.