Digital mental health tools won't see clinical adoption without validation, industry players say

Earlier this week panelists at the World Medical Innovation Forum talked validation gaps, advantages and the future of digital mental health tools.
By Laura Lovett
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There is an app for just about everything, and the mental health space is no different. But industry experts warn that not all mental health apps are created equally. While there are exemplars of tools that have been clinically validated, there is also a slew of technologies that have not been tested at all. 

“There are lot of opportunities for patients to receive bad care through apps right now,” Jennifer Gentile, SVP of US clinical operations of Ieso Digital Health, said during a panel at the World Medical Innovation Forum in Boston earlier this week. “It is very important that it is evidence-based care and not given by unlicensed clinicians, or given by a job coach or someone who really wants to give advice, but rather someone that has training, has patient experience, and [that] there are a lot of [evidence] assuring this is good care.”

This has been a hot topic in the industry recently after a study was published in Nature Digital Medicine that found a majority of mental apps studied did not provide evidence or peer-reviewed studies to back up their product. In fact, in that study only two out of the 73 apps studied provided evidence from a study using the app. 

Further, the definition of a “mental health app” is ambiguous, since meditation and wellness apps are commonly lumped into this category. 

“One of the critical elements is there isn’t enough clinicians, medical or scientific, to be involved in a lot of the apps out there that call themselves mental health apps,” Dr. David Silbersweig, chairman at the department of psychiatry at Brigham and Women’s Health and professor at Harvard Medical School, said during the panel. “And there is a slippery slope from mental health to wellness, and calmness and relaxation and stress reduction etc. … We need to decide as a field so it is evidence based and pathology based, and also realize there is need for prevention and stress reduction.”

Nevertheless, mental health digital tools have advantages over traditional pills, according to Jeremy Sohn, VP and global head of digital business development and licensing at Novartis. 

“A lot of the digital therapeutics that we have been evaluating in neuroscience — substance abuse disorder, to opioid addiction, to MS, to schizophrenia — [can offer] fewer side effects. So you are not seeing the chemical based side effects you normally see — neurotoxicity, atrial fibrillation,” Sohn said. “So in that context you can actually deliver a best-in-class therapeutic without having to worry about the normal body response.”

However, Sohn, whose company was a partner in creating the FDA-cleared digital therapeutic reSET, assured the audience that these digital treatments did prompt chemical response, and positively change patients' neural plasticity. 

While the pros include fewer side effects and the ability to scale, panelist stress the that tools have to be implemented correctly. 

“The area where it seems like we have only upsides is actually using software to deliver what we actually know is actually best practice standard of care,” Dr. Thomas McCoy, director of research at the Center for Quantitative Health at MGH and assistant professor at Harvard Medical School, said during the panel. “I think if we step back and we are honest with ourself, we actually very routinely fail to deliver on delivering best practice of care. So the words “standard of care,” I think, covers a lot of sins.”

While the panelists agreed that efficacy was crucial, they were also in concordance on digital's potential. 

“What I’m hearing is that in the future we need apps that are not only fun and engaging to users but also apps that are relevant that are evidence based,” Sabine Wilhelm, chief psychology director of OCD and related disorder programs at MGH, said while moderating the panel. “There are actually very few apps or AI tools that are evidence based [and] we are still very much in the early stages. It is a very exciting field, but there is not so much research to support it yet.”