Supporting clinicians with effective digital treatments

Last week, we announced an exclusive partnership with the American Psychological Association (APA) to advance education on the benefits of digital treatments for common mental health conditions like insomnia, anxiety, and depression.

To help unpack the significance of this partnership and why Big Health is uniquely positioned to support clinicians in addressing the growing mental health crisis in the US, we spoke with Jenna Carl, PhD, practicing psychologist and Chief Medical Officer at Big Health.

How can digital treatments be a solution for the growing mental health crisis?

Dr. Carl: We know that the national mental health crisis is worsening, both for adults and adolescents. Currently, over 50 million US adults are struggling with mental health difficulties. The pandemic exacerbated the youth mental health crisis, more than doubling depression and anxiety rates. Yet most who need care don’t receive it — the latest figures show up to 80% of young people and over half of adults don’t receive adequate treatment, largely due to access challenges, a shortage of trained clinicians, and longstanding stigma around seeking mental health care. For those who do receive care, most only receive medication—the default treatment approach, though 75% of patients say they would prefer a non-drug, behavioral care option.

Clinicians are also facing steep challenges. The APA’s 2022 COVID-19 Practitioner Impact survey found that six in 10 clinicians no longer have openings for patient visits; three-quarters report longer waitlists versus pre-pandemic. We see clinically validated digital treatments as uniquely positioned to support clinical care delivery, broadening access and scaling to meet demand as first-line recommended, non-drug options.

How can digital treatments support practicing clinicians who are treating patients with mental health conditions?

Dr. Carl: Digital treatments are intended to support practicing clinicians, not replace them. Sleepio, Daylight, and SparkRx, which were built based on the principles of cognitive behavioral therapy (CBT), can complement other care methods or be utilized as the primary treatment based on the clinician’s assessment and care plan. Therapists can use these digital treatments to augment care between their face-to-face sessions, to treat a comorbid condition (e.g., when treating depression, a therapist may add Sleepio for the treatment of comorbid insomnia), or to increase their practice efficiency and capacity to care for more patients. Physicians and nurse practitioners can use digital treatments as first-line treatments ahead of medication, to augment a medication regimen, or to help with deprescribing and tapering of medications (e.g., a psychiatrist may use Daylight with a patient who they are helping taper off of benzodiazepine medications for their anxiety). These tailored digital treatments are available 24/7 and can be used on demand, eliminating many access challenges that present in health care settings. This offers a helping hand to the countless clinicians who are struggling to meet the needs of the 163 million people living in health care professional shortage areas in the US. Plus, by offering different options for care, clinicians can help those with untreated mental health conditions who may be avoiding seeking care due to factors like stigma.

Why is this exclusive partnership such an important way to widen access to digital treatments?

Dr. Carl: I’m an active member of the American Psychological Association, as are the many psychologists we have working at Big Health. As clinical professionals, we see significant potential for clinicians to incorporate digitally delivered, clinically validated treatments into their patient care plans. These interventions are delivered via patients’ personal devices, where they can access clinically validated CBT-based treatments when it’s convenient for them. It’s these types of unique partnerships that can unlock access to care for the millions of people with untreated or poorly managed mental health conditions who seek safe and effective non-drug treatments.

That’s where we see Big Health playing a valuable role – as a future partner in care with psychologists and other mental health care providers. We’re a category pioneer offering safe and effective digital treatments for insomnia, anxiety, and depression, with programs targeting both adults and adolescents. Since our founding over ten years ago, our research-based, fully automated treatments have established what’s now known as the digital therapeutics category. Our programs are evidence-based and use a proprietary formulation of CBT to deliver meaningful outcomes via digital devices. CBT is a gold standard in the treatment of insomnia, anxiety, and depression that works by helping people break the cycle of unhelpful thoughts, emotions, and behaviors.

Psychologists, like all health care professionals, heavily rely on clinical evidence to guide treatment decisions. What clinical evidence has Big Health produced to demonstrate the efficacy of digital treatments?

Dr. Carl: At Big Health, we pride ourselves on our commitment to clinical science and evidence. Our treatments have been rigorously tested for safety and efficacy. Our results have been published in over 80 peer-reviewed publications, including 15 gold-standard randomized controlled clinical trials, and we have enrolled nearly 30,000 participants in our research studies. Our flagship treatment, Sleepio for insomnia, was the first-ever digital therapeutic to receive official guidance from the National Institute for Health and Care Excellence (NICE), a UK clinical authority that provides guidance on the most clinically validated and cost-effective care practices. NICE’s guidance recommended Sleepio as a first-line treatment for insomnia, confirming its effectiveness.

Additionally, Sleepio is referenced in multiple additional clinical treatment guidelines authored by independent clinical bodies: the American College of Physicians, the British Association for Psychopharmacology, and the European Sleep Research Society. This growing body of clinical evidence is a testament to the efficacy of our products in treating some of the most common mental health conditions — insomnia, anxiety, and depression. In a randomized clinical trial, 76% of participants using Sleepio saw a significant clinical improvement in insomnia, while in another randomized controlled trial, 71% of participants using Daylight saw a significant clinical improvement in anxiety. Our latest addition to the product portfolio, SparkRx for adolescent depression, is also supported by randomized controlled trial data demonstrating a clinically meaningful reduction in depression symptoms.

What’s the difference between clinical-grade digital treatments and wellness apps?

Dr. Carl: Clinical-grade digital treatments are designed to achieve lasting results — treatments like Sleepio and Daylight help people overcome their mental health conditions for good, rather than temporarily masking the symptoms. While wellness apps support well-being through lifestyle modifications focused on diet, exercise, meditation, and other daily habits, they are not clinical treatments for mental health conditions. They are also not subject to the same rigorous scrutiny from the scientific community that is the standard for true medical interventions and necessary to prove clinical efficacy and safety. While wellness apps, generally speaking, are not harmful, they are often not helpful. Digital treatments, on the other hand, are clinically validated through randomized controlled trials to confirm safety and effectiveness.

Learn more about how Big Health and similar organizations are working to make digital treatments more accessible.

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.

In accordance with FDA’s Current Enforcement Discretion Policy for Digital Health Devices for Psychiatric Disorders, for patients who are followed by and diagnosed with depression by a medical provider, SparkRx can be made available as an adjunct to their usual medical care for depression. SparkRx does not replace the care of a medical provider or a patient’s medication. SparkRx has not been cleared by the U.S. Food and Drug Administration (FDA) for these indications.

DOC-3112 Effective 08/2023