We believe evidence is a duty, not a chore
Our digital therapeutics aren’t just based on science: They’ve been proven effective in gold-standard clinical trials.
Setting the standard for rigorous clinical evidence
We believe digital therapeutics must be put to the test as rigorously as traditional medicine. People’s mental health depends on it. That belief not only fuels our commitment to clinical evidence — it also drives our efforts to make research more equitable for underserved populations.
75
Publications
14
Randomized controlled trials (RCTs)
28k+
Study participants
4
Clinical guideline citations1-4

Sleepio helped 76% of patients achieve clinical improvement in insomnia
In the world’s first placebo-controlled trial for a digital therapeutic, Sleepio was shown to be significantly more effective than the placebo. After six weeks, 76% of Sleepio patients achieved clinical improvement in insomnia.5

Daylight helped 71% of patients achieve clinical improvement in anxiety
In a landmark study, Daylight demonstrated significantly greater reductions in symptoms of clinical anxiety than the control condition. After 10 weeks, 71% of Daylight patients moved from clinical to non-clinical levels of anxiety, as compared to 33% of those in the control group.6
Featured studies
The effects of dCBT for insomnia on cognitive function
Read paperEfficacy of dCBT for moderate-to-severe symptoms of generalized anxiety disorder
Read paperA randomized controlled trial of dCBT for insomnia in pregnant women
Read paperEfficacy of dCBT for the treatment of insomnia symptoms among pregnant women
Read paperA pilot RCT for dCBT for sub-threshold insomnia
Read paperEfficacy of dCBT for insomnia to improve depression across demographic groups
Read paperRCT on impact of dCBT for insomnia on health, wellbeing, and quality of life
Read paperThe effects of improving sleep on mental health (OASIS)
Read paperSleep to lower elevated blood pressure (SLEPT)
Read paperHelping employees sleep well: effects of CBT for insomnia on work outcomes
Read paperSleep and productivity benefits of digital CBTi
Read paperThe anxiolytic effects of cognitive behavior therapy for insomnia
Read paperRCT of placebo controlled dCBT for chronic insomnia disorder
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Landmark study reveals the effectiveness of Daylight in improving anxiety
Dr. Jenna Carl helps leading employers contextualize the results of a landmark clinical trial evaluating the safety and efficacy of…

New study finds digital CBT the most cost effective option for poor sleep, when compared to other leading choices
Digital Cognitive Behavioral Therapy (dCBT), as delivered by Sleepio, was found to be the most cost-effective intervention overcoming poor sleep.

How DTx Will Set the Standard for Evidence in Digital Health: A Presentation from DTx West
DTx might be the future of mental health care. But only if companies prioritize high-quality research above quick turnaround.
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.
1. Qaseem, A., Kansagara, D., Forciea, M. A., Cooke, M., & Denberg, T. D. (2016). Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 165(2), 125-133.
2. Riemann, D., Baglioni, C., Bassetti, C., Bjorvatn, B., Dolenc Groselj, L., Ellis, J. G., … & Spiegelhalder, K. (2017). European guideline for the diagnosis and treatment of insomnia. Journal of Sleep Research, 26(6), 675-700.
3. Wilson, S., Anderson, K., Baldwin, D., Dijk, D. J., Espie, A., Espie, C., … & Sharpley, A. (2019). British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update. Journal of Psychopharmacology, 33(8), 923-947.
4. King’s Technology Evaluation Centre. (2017, November 9). Overview: Health app: SLEEPIO for adults with poor Sleep: Advice. NICE. https://www.nice.org.uk/advice/mib129.
5. Espie, C. A., Kyle, S. D., Williams, C., Ong, J. C., Douglas, N. J., Hames, P., & Brown, J. S. (2012). A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep, 35(6), 769-781.
6. Carl, J. R., Miller, C. B., Henry, A. L., Davis, M. L., Stott, R., Smits, J. A., … & Espie, C. A. (2020). Efficacy of digital cognitive behavioral therapy for moderate‐to‐severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depression and Anxiety, 37(12), 1168-1178.