Although an increase in telehealth has significantly improved access to care for many Americans, a shortage of qualified professionals makes it difficult for people to get the services they need. While no app is a substitute for therapy services, they can supplement therapy and offer additional support. The Food and Drug Administration (FDA) is the federal agency responsible for protecting public health by regulating food safety, medications, manufacturing, medical devices, and many other industries. Anyone with sufficient knowledge of coding can release an app, so the FDA has begun offering an approval process for these apps to demonstrate their effectiveness.
How Does the FDA Approve Apps?
According to the FDA’s website, “The FDA encourages the development of mobile medical apps (MMAs) that improve health care and provide consumers and health care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices—including mobile medical apps.” Essentially, technology has allowed access to resources for health and wellness that were never possible before. At the same time, though, anyone can create an app. The FDA’s role is to ensure that these apps do what they claim to do, provide support based on evidence, and benefit the people using them. The FDA regulates apps that function as medical devices, so if an app merely provides education about mental health, it is not eligible for FDA approval. However, if an app provides a therapeutic intervention (for example), the creators might seek FDA approval to certify their app. It can take years for an app to be approved, and the FDA might approve a specific function of the app rather than the app in its entirety.
What Does It Mean If an App Is FDA-Approved?
If an app is FDA-approved, this means that the developers went through the process of requesting this approval and demonstrated that their app meets the criteria for software as a medical device. For the software to be considered a medical device, it must be “intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” The FDA thoroughly vets apps before approving them, and it has high standards to provide this approval. Typically, an app that receives FDA approval will require a prescription and be used in conjunction with therapy or other treatment services.
Which Apps Are FDA Approved?
As of the writing of this article, the FDA has approved five mental health apps, listed below.
EndeavorRx
EndeavorRx is a video game designed to treat ADHD and received FDA approval in 2020. To subscribe to the app, you must have a prescription from a healthcare provider that verifies your diagnosis and the need for treatment. The app uses a science fiction backdrop to practice focus and attention using an evidence-based protocol. Clients are given a three-month prescription (which can be extended as needed) to play the video game daily to improve attention. The game provides fun but challenging activities that teach the player to sustain attention, prioritize and selectively focus, and attend to multiple stimuli at a time. EndeavorRx is the first-ever video game to receive FDA approval to treat attention-deficit/hyperactivity disorder (ADHD). Before receiving approval, the creators of EndeavorRx completed four peer-reviewed studies to show that the game effectively improves ADHD symptoms.
NightWare
NightWare advertises as a treatment for “nightmare disorder” or nightmares caused by post-traumatic stress disorder (PTSD). It is a digital watch that uses software to monitor physiological experiences while the wearer is asleep. It is not available on any app store and requires a prescription from a healthcare provider. Clients wear the device, which senses nightmares or disturbing dreams and uses vibration to wake the client and end the dream. Research showed improvement in anxiety symptoms, reduced nightmares, and overall improved sleep quality when wearing the NightWare device. NightWare was approved as a treatment for nightmares in 2020 in adults age 22 and older.
ReSET
When searching for the reSET app, multiple options appear. The FDA-approved reSET app is designed to treat substance use disorders (SUDs). It was developed to supplement outpatient treatment for alcohol, cocaine, marijuana, and stimulant abuse. You need an access code provided by a healthcare professional in order to use reSET, and it uses a client and clinician dashboard to teach cognitive behavioral skills to support abstinence from the addictive substance. The app was shown to improve treatment outcomes when used in conjunction with outpatient SUD treatment. This app is not approved for treating alcohol abuse in the absence of additional substance abuse, and it is not approved for opioid treatment.
ReSET-O
ReSET-O was created by the same minds behind reSET and was developed to expand the reSET app’s functions to include treatment for opioid use disorder. Like the reSET app, it uses tenets of cognitive behavioral therapy to help clients abstain from opioid use. As with the original reSET app, reSET-O requires a prescription and is intended for collaborative use between clients and treatment providers. Unlike the reSET app, reSET-O did not have peer-reviewed research showing that it decreased opioid use in users at the time of approval. However, reSET-O users had a higher rate of retention in outpatient programs compared to those who did not use reSET-O to supplement their treatment. The FDA granted approval for reSET-O through premarket registration.
Somryst
Somryst is an app designed to train the brain to get higher-quality sleep, and it is FDA-approved for treating insomnia using cognitive behavioral therapy for insomnia (CBT-I). It is approved for use by individuals aged 22 and older who speak and read English, live in the United States, and are able to use the app. Somryst requires that users be under the care of a medical provider. Somryst uses six lessons based in CBT-I that individuals can complete at their own pace over the course of nine weeks. It provides specific instructions based on evidence-based treatment for insomnia to help clients sleep better. If you feel that an app discussed in this article would benefit your treatment, talk to your healthcare provider(s) about your options. By regulating mental health apps, the FDA is implementing standards for these kinds of resources. This ensures that users know the risks and benefits of the apps and can rely on an evidence base for these claims. In addition, providers can make confident recommendations knowing that the FDA vetted these resources first.
