Convenience wins—whether it means shopping online, because my favorite store is far from home, or telehealth that gives me the option of connecting remotely with my clinical care provider. The technological revolution in healthcare has transformed how many of us seek care, including the use of mental therapy apps. This is particularly relevant in the current context, with pandemic-related stresses and the severe shortage of mental health professionals. An app can provide instant access to care and might cost less than visiting a professional.
But do we know if these apps work? How well are they regulated?
When researchers compared mobile apps for mental health care that involved close to 50,000 patients, they were not convinced that the apps were successful at improving patient outcomes for:
- Depression
- Smoking or drinking
- Suicidal thoughts
- General feeling of well-being
Are These Apps Regulated?
According to the American Psychiatric Association (APA), there is not enough oversight of mental health apps. The FDA only reviews those apps that claim to be a medical device—meaning if the app provides an intervention or treatment—not if it’s an educational app. This means the discretion to choose a safe and effective app is in the user’s hands. Unfortunately, the convenience of an app carries with it the risk of:
- Incorrect or misleading information for patients
- Ineffective services, which could be interpreted as the patient being unresponsive
- Patient health data privacy, among others
The APA has developed the APP Advisor that can be used by mental health professionals and psychiatrists to help evaluate the quality of an app for their patients.
A team of behavioral health experts in the U.S. and in Australia partnered to evaluate 73 top-rated mental health apps on iTunes and Google Play for effectiveness and to ascertain their scientific claims. While 64% of the apps cited scientific evidence that inspired their app, a majority failed to use that evidence in creating their app or sharing the findings in a paper.
According to John Torous, MD, MBI, one of the co-authors of this study, the terms and conditions of these apps often indicate that they are a self-help tool rather than a mental health service. He recommends that these apps can be used to complement or provide additional support to patients who are receiving clinical care with a healthcare specialist. Information that the apps gather can be used to personalize the treatment that a patient receives, not replace the care provider, he adds.
FDA-approved Mental therapy Apps
The apps listed below have been approved by the FDA and require a physician’s prescription:
- reSET: Approved for the treatment of substance use disorders as an outpatient treatment for alcohol. Cocaine, marijuana, and stimulant substance use disorders.
- reSET-O: Expands the function of reset to include opioid use disorders.
- NightWare: approved for the treatment of temporary reduction of sleep disturbance related to nightmares in adults over 22 who suffer from nightmare disorder or nightmares from post-traumatic stress disorder.
- Somryst: Approved for treating chronic insomnia among patients 22 years and older.
- EndeavorRx: Game-based devise to treat children with attention deficit hyperactivity disorder.
Clinical organizations have been working to move this field forward to ensure the safety of these apps. The American Psychological Association has created an Office of Health Care Innovation to address digital therapeutics in psychological care and is also partnering with the FDA on the regulatory process.
Despite the tremendous potential of these apps, the field remains in its infancy.

Surabhi Dangi-Garimella, Ph.D. is a biologist with academic research experience, who brings her skills and knowledge to the health care communications world. She provides writing and strategic support to non-profit groups via her consultancy, SDG AdvoHealth, LLC.