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New JAMA Study Showcases Clinical Benefits of SleepioRx in Patients with Comorbid Insomnia and Depression Symptoms, Marking 100+ Peer-Reviewed Papers for Big Health
March 10, 2025
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6
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New JAMA Study Showcases Clinical Benefits of SleepioRx in Patients with Comorbid Insomnia and Depression Symptoms, Marking 100+ Peer-Reviewed Papers for Big Health

by

Big Health has reached a major milestone during Sleep Awareness Week: the publication of over 100 peer-reviewed papers that validate our digital solutions and methods for treating insomnia and other common mental health conditions. 

This milestone underscores our ongoing commitment to providing accessible, evidence-based mental health solutions for the millions who need support. We’re proud to advance the science of sleep and mental health, and we’re excited to see the impact these findings will have on patients and clinical practice. 

The latest paper (link here), published by Journal of the American Medical Association (JAMA), investigates the use of SleepioRx, an FDA-cleared digital insomnia treatment based on guideline-recommended cognitive behavioral therapy for insomnia (CBT-I), on patients who have both chronic insomnia and depression. 

The blinded randomized controlled trial, led by researchers at Oxford University, investigated whether digital cognitive behavioral therapy for insomnia modifies negative bias in the perception of emotional facial expressions and whether that in turn leads to improvement in depressive symptoms. 

205 participants were followed over ten weeks after being randomly assigned to SleepioRx or Sleep Hygiene Education, a component of standard of care treatment for insomnia. 

The study builds on the larger body of evidence confirming that SleepioRx is an effective treatment for insomnia, showing large treatment effects in insomnia symptoms as measured on the Insomnia Severity Index (ISI), when compared to the control arm. 

Of interest, the study showed that use of SleepioRx also led to large treatment effects on depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), compared to the control arm. 

We are excited to see further research expand on this work.

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SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia / insomnia disorder as an adjunct to usual care in patients aged 18 and older. SleepioRx is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider. 

Sleepio is not intended for treatment of depression, and has not been reviewed or cleared by FDA for this purpose.

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DOC-3838 Effective March 2025

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February 12, 2026
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6
min

Big Health Secures Funding to Accelerate Adoption of Digital Mental Health Treatments

New investment fuels expansion as leading health systems adopt evidence-based digital care, driven by new billing codes and strong demand for proven mental health solutions.
March 25, 2025
·
12
min

FDA-Cleared Digital Treatments are Shaping the Future of Mental Healthcare

Proven non-drug options are now available–and reimbursable– for insomnia and anxiety.
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1. 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.
2. Carl, J. R., Miller, C. B., Henry, A. L., Davis, M. L., Stott, R., Smits, J. A. J., Emsley, R., Gu, J., Shin, O., Otto, M. W., Craske, M. G., Saunders, K. E. A., Goodwin, G. M., & 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. https://doi.org/10.1002/da.23079
3. Unpublished RCT data, Dec 2023. Stat reflects a 25% improvement in scores on a validated screening measure. Screening tools alone are not sufficient to diagnose depression.
Sleepio, Daylight, and Spark Direct are digital programs that may help individuals live well with mental health conditions and symptoms by providing them with cognitive and behavioral techniques that can improve sleep, feelings of worry and anxiety, and mood, respectively. Sleepio, Daylight, and Spark Direct have not been reviewed or approved by the Food & Drug Administration and are not intended to diagnose or treat any medical condition. Please read the instructions for use