Anna Andoni, MD, Ben Rosner, MD, PhD, and Haala Rokadia, MD in conjunction with the Network of Digital Evidence, NODE.Health
May is Mental Health Awareness Month, a time to shine a spotlight on mental health needs in our country, and to honor those who provide support, professionally and personally, to individuals with mental illness. There is no more important time to do so than in the current coronavirus pandemic. It is also a time to focus on and support the mental wellbeing of frontline healthcare workers who are dealing with the surge of COVID-19 patients in our hardest hit communities.
Recently, two front-line healthcare workers in New York City took their own lives: Dr. Lorna Breen, an emergency department physician from New York Presbyterian, and John Mondello, an emergency medical technician from the Bronx. The suicides of these healthcare workers highlight the importance of supporting the mental health needs of frontline workers in a time of crisis and profound emotional and physical stress.
Healthcare workers who are experiencing traumatizing work conditions and unparalleled stress levels need expanded access to mental health resources and education.(1) One such way of expanding access to mental healthcare is through digital mental health platforms and apps. However, in the sea of well-intentioned mental health apps and platforms, how does one choose the best app based on evidence?
Currently, there are over 10,000 mental health-related apps that have the ability to transform a patient’s smartphone into a monitoring and therapeutic device; however, these apps offer very little evidence of their use and some may even offer harmful and dangerous advice. (2) A study published in Nature Digital Medicine found that a majority of mental health apps are not backed by peer-reviewed evidence, with only 2 of the 73 apps that were surveyed citing evidence from a study with scientific language as the major driver of effectiveness claims based on searchable keywords for the apps in Google Play and iTunes.(3) Furthermore, there is a lack of standardized guidelines and principles to direct individuals seeking mental health care to the right apps for them using a systematized, expert-reviewed or evaluative approach.
In our search for evidence for mental health apps, we found different approaches used to evaluate these apps. The nonprofit One Mind has created Psyberguide, a mental health app guide that features a scoring system for apps in order to provide accurate and reliable information free of preference, bias, or endorsement. (4) The scoring system is based on 3 main factors: credibility, user experience, and transparency. Psyberguide offers a searchable database of 177 mental health apps that can be categorized based on mental health condition and factor rank. Some of the apps also include in-depth expert evaluations backed by peer-reviewed literature. Recently, Psyberguide has partnered with the Anxiety and Depression Association of America to rate mental health apps and determined that some of the best mobile apps for general mental health are Calm and Headspace, which offer mindfulness as their foundation for dealing with depression and anxiety.(5)
Another approach proposes an evaluative framework created by the American Psychiatric Association (APA) for selecting a mental health app. The APA model was created in 2018 under the guidance of the APA Workgroup on Smartphone Evaluation chaired by John Torous, MD, of Beth Israel Deaconess Medical Center. It is based on risk and personalized assessment that doesn’t offer ratings or recommendations for specific apps. Instead, it provides a 357 question informed decision-making framework that consists of 5 tiers for evaluation, including: background, risk in terms of privacy and security, evidence, ease of use, and data integration and interoperability.(6)
The goals of both the framework and app rating approaches are to help individuals with mental healthcare needs — either patient or provider — make informed decisions about digital health apps. Although it remains unknown how many people use behavioral health platforms and mental health apps for mental well-being, online therapy providers such as Talkspace have seen a 65% increase since mid-February with coronavirus-related anxiety dominating patients’ concerns. (7) Talkspace is also trying to help frontline workers by donating 1000 months of e-therapy to them in an initiative which began March 19th. Another platform partnered with University of North Carolina (UNC) to create Project Parachute, helping frontline healthcare workers by offering free therapy sessions given by volunteer therapists. These examples demonstrate the value of reduced lead time to implementation during a time of crisis.
Before the pandemic, there were few mental health apps that had received FDA approval. A rare example is reSET® by Pear Therapeutics, a 12-week prescription for substance use disorder to be used as an adjunct to standard outpatient care which was approved by the FDA as a de novo device in 2017. However, in April, the FDA released new guidance for industry entitled, “Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” (8) Under this relaxed enforcement policy, the FDA is attempting to “help expand the availability of digital health therapeutic devices for psychiatric disorders to facilitate consumer and patient use while reducing user and healthcare provider contact and potential exposure to COVID-19 .”(9) In this regulatory environment, digital mental health solutions meeting certain FDA criteria can be brought to market or used in clinical contexts more readily. Pear Therapeutics has recently taken advantage of the new regulatory environment with the rollout of its schizophrenia digital therapeutic for limited distribution, PEAR-004, that may improve access to mental healthcare in a time when regular physician visits aren’t possible.(10) Another digital health company, Akili Therapeutics, has also fast-tracked approval for an ADHD digital therapeutic under emergency release.(11) FDA’s COVID-19 guidelines state that it will not enforce regulatory requirements on general wellness apps that may aid users in living well during the COVID-19 public health emergency”.(8) Apart from looking at rankings and evaluation models, there also exist sites such as UCSF’s COVID-19 psychiatry resource guide recommending quality mental and wellness apps categorized by need such as meditation, coping with stress and anxiety and insomnia.
Digital mental health tools can be powerful adjuncts to help scale up the reach of the professional mental health workforce in a time of unprecedented demand, and can help provide reassurance to those in need. In order to improve engagement and adoption of these solutions, we need to employ a more systematic, personalized approach for discovering and recommending digital mental health apps and platforms.
NODE.Health Foundation is a 501(c)(3) non-profit organization dedicated to education, validation and dissemination of evidence based digital medicine. As the largest professional association in digital medicine, NODE.Health empowers societies, executives and NODES from health systems, payers, life sciences, venture capital, startups and the public sector involved in healthcare digital transformation. NODE.Health does not endorse any specific products or services.
NODE.Health is pleased to cross post this article giving examples of digital mental health apps and platforms for public benefit. NODE.Health encourages its readers to be diligent with selecting such tools and understand the evidence. As more evidence comes out on the use of such tools for COVID-19, NODE.Health will keep its readers informed. Interested in learning more about the Network of Digital Evidence (NODE.Health)? Click here
- Santarone, Kristen et al. “Preserving mental health and resilience in frontline healthcare workers during COVID-19.” The American journal of emergency medicine, S0735-6757(20)30258-8. 15 Apr. 2020, doi:10.1016/j.ajem.2020.04.030
- Torous J, Roberts LW. Needed Innovation in Digital Health and Smartphone Applications for Mental Health: Transparency and Trust. JAMA Psychiatry. 2017;74(5):437–438. doi:10.1001/jamapsychiatry.2017.0262
- Larsen, M.E., Huckvale, K., Nicholas, J. et al. Using science to sell apps: Evaluation of mental health app store quality claims. npj Digit. Med. 2, 18 (2019). https://doi.org/10.1038/s41746-019-0093-1
- PsyberGuide. 2020. Psyberguide | The Mental Health App Guide Designed With You In Mind. [online] Available at: https://www.psyberguide.org/ [Accessed 7 May 2020].
- Kaufman, J., 2020. Mindset Matters: Operationalizing The Business Of Empathy In The Era Of COVID-19. [online] Forbes. Available at: https://www.forbes.com/sites/jonathankaufman/2020/04/24/mindset-matters-operationalizing-the-business-of-empathy-in-the-era-of-covid-19/#668752901c1f [Accessed 7 May 2020].
- Henson, P., David, G., Albright, K. and Torous, J., 2019. Deriving a practical framework for the evaluation of health apps. The Lancet Digital Health, 1(2), pp.e52-e54.
- Washington Post 2020. The coronavirus pandemic is pushing America into a mental-health crisis[online] Available at: https://www.washingtonpost.com/health/2020/05/04/mental-health-coronavirus/ [Accessed 7 May 2020].
- FDA.org. April 2020. Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff. Available at: https://www.fda.gov/media/136939/download [Accessed 7 May 2020].
- Raps.org. 2020. FDA Eases Entry For Psychiatry Apps During COVID-19 Crisis. [online] Available at: https://www.raps.org/news-and-articles/news-articles/2020/4/fda-eases-entry-for-psychiatry-apps-during-covid-1 [Accessed 6 May 2020].
- MobiHealthNews. April 29, 2020. Pear Rolls Out Digital Therapeutic For Schizophrenia, After FDA Loosens Regulations In COVID-19 Response. [online] Available at: https://www.mobihealthnews.com/news/pear-rolls-out-digital-therapeutic-schizophrenia-after-fda-loosens-regulations-covid-19 [Accessed 7 May 2020].
- Dave Muoio. MobiHealthNews. April 22, 2020. Akili’s Digital Therapeutic Launches Early For Housebound Children With ADHD. [online] Available at: https://www.mobihealthnews.com/news/akilis-digital-therapeutic-launches-early-housebound-children-adhd [Accessed 7 May 2020].