While no app is a substitute for therapy services, apps can supplement therapy and offer additional support.
How Does the FDA Approve Apps?
Essentially, technology has allowed access to resources for health and wellness that were never possible before.
Verywell / Laura Porter
At the same time, though, anyone can create an app.
What Does It Mean If an App Is FDA-Approved?
The FDA thoroughly vets apps before approving them, and it has high standards to provide this approval.
Which Apps Are FDA-Approved?
As of November 2024, the FDA has approved six mental health apps, listed below.
This app is meant to be used in conjunction with medication and outpatient treatment.
Approved in April of 2024, a prescription is required so you can sign up and use Rejoyn.
The app uses a science fiction backdrop to practice focus and attention using an evidence-based protocol.
EndeavorRx is the first-ever video game to receive FDA approval to treat attention-deficit/hyperactivity disorder (ADHD).
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.
NightWare was approved as a treatment for nightmares in 2020 in adults age 22 and older.
ReSET
When searching for thereSETapp, multiple options appear.
It was developed to supplement outpatient treatment for alcohol, cocaine, marijuana, and stimulant abuse.
The app was shown to improve treatment outcomes when used in conjunction with outpatient SUD treatment.
Like the reSET app, it uses tenets of cognitive behavioral therapy to help clients abstain from opioid use.
The FDA granted approval for reSET-O throughpremarket registration.
Somryst requires that users be under the care of a medical provider.
It provides specific instructions based on evidence-based treatment for insomnia to help clients sleep better.
What Does This Mean for the Mental Health Field?
Some, like Nightware, provide a therapeutic intervention that a traditional therapist cannot do.
By regulating mental health apps, the FDA is implementing standards for these kinds of resources.
In addition, providers can make confident recommendations knowing that the FDA vetted these resources first.
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NightWare.A modern option for your patients.
Food and Drug Administration.FDA permits marketing of mobile medical utility for substance use disorder.
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