We recently announced the results of a landmark clinical trial evaluating the safety and efficacy of Daylight, our fully-automated digital therapeutic, for improving symptoms of anxiety. The randomized controlled trial (RCT) was published in the peer-reviewed journal, Depression and Anxiety.
Dr. Jenna Carl, the study’s first author and Big Health’s vice president of clinical development and medical affairs, connected with us to help us interpret and contextualize the results for benefits leaders and their populations.
To dive right in, what is the key finding of this study?
Dr. Carl: This study was the first to evaluate a smartphone-based digital therapeutic in a clinical sample of adults with Generalized Anxiety Disorder or GAD. GAD is a mental health condition characterized by excessive and difficult-to-control worry and is considered challenging to treat.
We found that Daylight significantly reduced symptoms of anxiety in trial participants, as compared to the control group after six weeks. By week ten, 71% of Daylight users in the study achieved remission of GAD, as compared to 33% of those in the control group.
How did you determine anxiety levels for participant inclusion in the study?
Dr. Carl: Study participants met the DSM-5 criteria for Generalized Anxiety Disorder (GAD), indicating they had a clinically significant level of worry and anxiety and other symptoms consistent with the diagnosis. Adults with moderate-to-severe symptoms of GAD (as indicated by the GAD-7 measure at baseline) were included in the study.
We wanted to test Daylight in a population with significant levels of anxiety to ensure that the program would be helpful even for individuals with more challenging anxiety difficulties. These results tell us that Daylight can help individuals across a spectrum of anxiety difficulties, including at the higher levels. In addition, people suffering from more severe and longer lasting symptoms of worry and anxiety are in particular need of care—which is why we focused on this cohort.
You mentioned that 71% of Daylight users achieved clinically significant improvements in anxiety, but was that improvement maintained over time?
Dr. Carl: Great question. When cognitive and behavioral techniques are implemented they have lasting results, and our study findings were in line with that. Daylight users in the study maintained improvements through to a 6-month follow-up assessment. Notably, the 6-month follow-up period overlapped with the emergence of COVID-19, a time of increased stress and anxiety.
Why do you think the Daylight users were able to maintain their improved anxiety levels for such a long time, and during such a stressful time?
Dr. Carl: It is due to the form of help provided in Daylight. As the name implies, cognitive and behavioral techniques help people learn how to think and behave differently, and once you’ve learned and incorporated these kinds of changes into your life, they have lasting effects. We also put a lot of effort into designing Daylight in a way that would support learning and engagement—in addition to working with leading anxiety experts, we worked with top creatives in animation and storytelling from Pixar and NPR’s RadioLab—so I’d like to think our de-stigmatized and engaging design was also part of what helped so many make large and lasting improvements.
What implications do these results have on the future of mental healthcare?
This study has huge implications for how we think about increasing access to mental healthcare because 80% of the US population owns a smartphone. Given that most people with mental health difficulties do not receive care or receive only limited care (e.g., only medications or limited psychotherapy appointments), effective mental health programs delivered via smartphone could extend access and increase people’s options—including people’s preferred option. A little known fact is that 75% of mental health patients would prefer a psychological solution over medications. And it’s not possible to address the large unmet need solely with additional mental health providers, the shortage is too substantial. Plus, stigma is still an issue—some people don’t want in-person care.
With software, we have a better shot at reaching all of those suffering in silence. And since that software sits in the palm of a person’s hand, it has profound implications for the immediacy of its use: it can offer “on demand” tools and support to someone, in their exact moment of need.
Did you learn anything else from this study that is important to highlight?
Dr. Carl: It’s worth noting that we saw strong “between-group” effects in comparing improvements for Daylight users to those in the control condition. That is, even when “subtracting” any “placebo” effect of the control group from the Daylight group’s results, we still observed statistically significant and large improvements in anxiety symptoms for the Daylight group. This gives us confidence that the effects we saw with Daylight were a result of the program and not simply due to the person’s increased hope and expectation of receiving help.
Another important point is that Daylight use was associated with clinically and statistically significant improvements in worry, depressive symptoms, sleep difficulty, wellbeing and participant-specific quality of life. This matters because we know that anxiety doesn’t exist in a vacuum. In fact it’s the opposite, anxiety often co-occurs with sleep or mood disturbances. We’re encouraged by the findings that Daylight can help to address these coexisting mental health challenges.
Why did Big Health decide to conduct this study in the first place?
Dr. Carl: Big Health has an enduring commitment to evidence-based care, which means we must conduct highly quality clinical research on our programs. Keep in mind a dozen randomized controlled trials or RCTs have been completed for Sleepio—and more under way—so conducting an RCT for Daylight was a natural step. The RCT is considered the “gold standard” in clinical trials research. This study validates the promising findings of our first study (which was a feasibility and preliminary efficacy study), but with a larger population and a control group. So this study included 256 participants—128 people who were randomly assigned to Daylight and 128 people randomly assigned to the control group.
Will there be additional Daylight RCTs? If so, what kinds of questions will you seek to answer in additional studies?
Dr. Carl: There will absolutely be additional RCTs. While we are excited by the results of this study, we have much more to learn about Daylight. For example, we want to study the effects of Daylight on other comorbid mental health conditions, such as social anxiety and depression, as well as chronic health conditions such as diabetes or cardiovascular disease. We are also committed to evaluating our programs within underserved populations who are often not well represented in research—helping us to ensure that our programs are effective across broad populations.
Thank you for your time today Dr. Carl, this has been very insightful.
Dr. Carl: You are quite welcome. We look forward to sharing the results of additional research in the months and years to come.
Disclaimer: In accordance with FDA’s Current Enforcement Discretion Policy for Digital Health Devices for Psychiatric Disorders, for patients aged 18 years and older, who are followed by and diagnosed with Insomnia Disorder or Generalized Anxiety Disorder by a medical provider, Sleepio and Daylight can be made available as an adjunct to their usual medical care for Insomnia Disorder or Generalized Anxiety Disorder, respectively. Sleepio and Daylight do not replace the care of a medical provider or the patient’s medication. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for these indications. Users are directed to not make any changes to their prescribed medication or other type of medical treatment without seeking professional medical advice.
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