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Separating Hope from Hype: The Need to Prioritize Mental Health Apps with Proven Results for Clinical Conditions

Digital therapeutics that are supported by meticulous testing provide scalable and efficacious clinical remedies that augment current mental health care.

Originally published in MedCity News

We can’t wait.

The country has only 659 behavioral sleep medicine clinicians who specialize in treating insomnia —which affects about one-third of the adult population—through CBT. A 2020 report by the Substance Abuse and Mental Health Services Administration (SAMHSA) showed the United States needs more than 4.4 million additional qualified mental health professionals to meet its unmet demand. We can’t wait for the number of qualified mental health professionals needed to treat everyone in need.  

The COVID-19 pandemic not only exposed the mental health crisis, but exacerbated it. I co-authored a study that surveyed more than 20,000 people between May and August of 2020 across 13 countries. The study showed that 25.6% of respondents met criteria for probable anxiety and 36.7% met criteria for a probable insomnia disorder. This far exceeded pre-pandemic levels.

In today’s world, living with a mental health condition has become the norm, not the exception. We need an immediate solution that improves access to mental health treatments. It must be scalable, and it must be safe and effective in treating clinical mental health conditions.

Digital wellness apps address the scalability challenge, but their efficacy as a clinical treatment is questionable. A recent study in PLOS Digital Health gauged the effectiveness of mobile phone-based interventions for mental health. It was an impressive undertaking –  a meta-review synthesizing data from 14 meta-analyses, which included 145 randomized controlled trials and nearly 48,000 participants. The results were (partly) promising: the potential for digital solutions is high, with the opportunity to reach millions of people around the world. But the results were troubling, too. They showed that the effectiveness of many wellness apps remains doubtful in treating clinical mental health conditions like anxiety and depression.

Some wellness solutions – even the most commercially successful – are optimized for marketing and engagement rather than robust clinical data and successful treatment outcomes. Headspace, for example, boasts more than 70 million users, has its own Netflix series, and recently launched a Superbowl advertisement. But according to the review its supporting evidence, like many other products, does not indicate a clinically significant impact on mental health conditions. In fact, a controlled study showed that Headspace had a small effect size for depression symptoms – meaning the treatment effects aren’t clinically significant, and people likely didn’t notice an impact on their condition. This finding is consistent across Headspace’s evidence base, which also demonstrates small effect sizes compared to control for worry and anxiety. In addition, Headspace’s evidence base focuses on measuring healthy individuals for a wide majority of studies rather than those who meet the criteria for clinical mental health issues. This further demonstrates a focus on wellness and prevention rather than the treatment of clinical conditions.  

A divide has clearly emerged between wellness apps, which are not proven clinical interventions, and digital therapeutics, which, through data and rigorous studies, are shown to be safe and effective treatments for mental health. In fact, STAT News reporter Mario Aguilar recently covered the importance of digital therapeutics proving their effectiveness through clinical evidence. Given the growing prevalence of clinical mental health conditions, more solutions should be focused on the latter.  

Headspace isn’t alone. The PLOS Digital Health meta-review showed that effect sizes of many apps were inversely proportional to the rigor of the studies evaluating them; the more rigorous the comparison condition, the smaller the effect size. For something as important as mental health, digital solutions need to be backed by convincing data before being offered to people with mental health conditions. Simply put, we wouldn’t offer someone with cancer vitamins when they need access to chemotherapy. To take mental health conditions seriously, we must adopt the same focus on providing evidence-based treatments to everyone in need.

Big Health offers two products, Daylight and Sleepio. Daylight offers digital CBT to treat generalized anxiety disorder. In a two-arm, randomized, controlled trial with waitlist control, Daylight reduced anxiety symptoms, with a large effect size – indicating significant day-to-day clinical improvements. Participants who used Daylight also experienced significant improvements in their depressive symptoms, quality of sleep, and quality of life. In another peer-reviewed study, 71% of Daylight users achieved clinical improvement in anxiety.

Sleepio guides users through weekly CBT sessions to treat insomnia. In a randomized, placebo-controlled trial, Sleepio users experienced sustained improvement in their quality of sleep and daytime functioning when compared to the placebo group. Another controlled trial with over 1,700 randomized participants showed that Sleepio improved functional health, psychological well-being, and sleep-related quality of life.

While some mobile phone-based interventions, like wellness and meditation apps, show unrealized potential, others, like Big Health’s digital therapeutics, already have clinical grade evidence from rigorous studies that support their claims. I agree with the findings of the meta-review: the potential of digital mental health interventions is great, but they require testing to prove they meet the needs of the moment, including clinical treatment for common mental health conditions like depression, anxiety, and insomnia.

Imagine what replacing wellness solutions with digital therapeutics could do… Millions of people living with mental health conditions would have access to clinical treatments to improve their anxiety symptoms, sleep, and overall well-being. Imagine the effects on mental and physical health, on family and community relations, and on workforce productivity. But, to accomplish this, we need to separate the proven from mere potential.

Digital therapeutics that are backed by rigorous testing offer effective, scalable clinical treatments which supplement existing mental health care. People with mental health problems deserve and need treatments that actually work. If some apps still haven’t provided the science that backs their claims, we need to focus on the ones that already have collected that evidence to forge the path ahead.

We can’t wait.

Sleepio and Daylight are available as an adjunct to usual medical care for insomnia disorder or generalized anxiety disorder, respectively, for adults ages 18 and older, without FDA review under their COVID-19 policy.

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During the COVID-19 public health emergency, Sleepio and Daylight are being made available as treatments for insomnia disorder and generalized anxiety disorder (GAD), respectively, without a prescription. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia disorder and GAD, respectively.

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