News /
min read /
September 1, 2021

Study demonstrates combining digital therapeutics for insomnia and IAPT therapy improves sleep, anxiety, and depression more than therapy alone


Twelve-month evaluation shows the value of incorporating Big Health’s Sleepio, a clinically-based digital therapeutic for insomnia, into a psychological therapies stepped-care model.

Buckinghamshire and London, UK September 1, 2021 Big Health, a digital therapeutics company dedicated to helping millions back to good mental health, and the Oxford Health NHS Foundation Trust today announced a joint study published in the Behaviour Research and Therapy journal showing almost two-thirds [65 percent] of people seeking treatment for anxiety or depression and who had sleep difficulty saw their mental health improve substantially more by combining enrollment in Sleepio1, Big Health’s digital therapeutic for insomnia, with NHS Improving Access to Psychological Therapies programme (IAPT) care, when compared to IAPT care alone. Additionally, participants using Sleepio reduced their utilisation of high-intensity IAPT treatment, including personalised therapy delivered by mental health professionals.

The study was a key part of a wider population mental health programme enabling any adult in the Thames Valley to access Sleepio through self-referral, general practitioner (GP) prescription, and mental health services. It was funded by a UK Research and Innovation grant, delivered with the Oxford Academic Health Science Network, and was hosted through NHS services, specifically Healthy Minds Bucks, the Buckinghamshire, England IAPT service.

To better understand the impact of incorporating Sleepio into a psychological therapies stepped-care model, researchers tracked more than 1,000 IAPT patients who had sleep and mental health issues. Half enrolled in Sleepio alongside NHS IAPT services. The control group did not access Sleepio. After 12 months, Sleepio users experienced significantly better outcomes in mood, anxiety, and social functioning. Recovery rates from standardised IAPT measures used to capture symptoms of anxiety (GAD-7) and depression (PHQ-9) were 65 percent for Sleepio users, versus 58 percent in the control group who received IAPT alone.

“We are proud to collaborate with Big Health on this innovative study, which shows the opportunity to further improve clinical outcomes through integration of a digital therapeutic for insomnia and evidence based psychological therapy for anxiety and depression.

Recovery rates for people with anxiety and depression receiving IAPT care in England are already good – however, we have found that we can improve them further with this additional digital intervention. Reflecting on the pandemic, increasingly we’ll need more scalable, evidenced digital interventions to augment our services, making care more efficient and effective.”

Dr. John Pimm, Clinical lead of Healthy Minds Bucks, the Buckinghamshire IAPT service, provided by Oxford Health NHS Foundation Trust

Poor sleep is rarely specifically addressed in primary care or mental health services, but clinical evidence shows that insomnia significantly impacts comorbid mental health conditions including depression and anxiety. According to leading treatment guidelines, including the National Institute for Health and Care Excellence (NICE), cognitive behavioural therapy (CBT) is recommended as the first line treatment for insomnia; however, the vast majority of patients are given medications or a long waiting list for therapy. Leading programmes, including Big Health’s Sleepio, deliver CBT in a digital format, providing 24/7 access to gold-standard treatment regardless of clinical setting. Sleepio’s approach is validated through industry-leading clinical evidence, including 12 randomised controlled trials, and NICE accreditation. Through the study, the Healthy Minds Bucks IAPT service sought to understand how integrating Sleepio into a psychological therapies stepped-care model would impact mental health outcomes within the service.

“This study represents Big Health’s unique ability to reach users across the clinical care pathway.

By supplementing existing clinical care with access to personalised and evidenced-based digital therapeutics, we can reach people with the right approach and at the right time to maximise outcomes.”

Dr. Colin Espie, Big Health Co-Founder and Chief Scientist, and Professor of Sleep Medicine at the University of Oxford.

The IAPT programme in England assesses approximately one million people each year and offers evidence-based psychological interventions, primarily for diagnoses of anxiety and depression. These services utilise a stepped-care model whereby most patients begin with a low-intensity intervention, such as a psychoeducation group. People with greater needs can be ‘stepped up’ to individual weekly therapy sessions or more intensive interventions. The NHS Long Term Plan is focused on expanding mental health services so that 1.9 million adults access treatment each year, integrating physical and mental health care, improving employment outcomes, and improving equitable access to care.

Oxford Health NHS Foundation Trust

Oxford Health NHS Foundation Trust (OHFT) provides physical, mental health and social care for people of all ages across Oxfordshire, Buckinghamshire, Swindon, Wiltshire, Bath and North East Somerset. Our services are delivered at community bases, hospitals, clinics and people’s homes. We focus on delivering care as close to home as possible.

As a leading teaching, training and research trust, we have close links to Oxford and Oxford Brookes, Buckinghamshire, Reading and Bath universities. We are part of the Oxford Academic Health Science Centre, working closely with our university colleagues to translate their findings into clinical care as quickly as possible, enabling people using our services to benefit from the latest advances in healthcare. We host the NIHR Oxford Health Biomedical Research Centre with Oxford University, and aim to bring the best science to the complex problems of mental disorders and dementia. We also host the NIHR Applied Research Collaboration Oxford and Thames Valley; a partnership between universities, healthcare, charities and industry, that aims, through applied health research, to co-produce better, more equitable, appropriate and sustainable health and care across the region.

For more information: contact the Communications Team on 01865 902068/902225.

About Big Health

Big Health’s mission is to help millions back to good mental health by providing safe and effective non-drug alternatives for the most common mental health conditions. Designed by leading clinical experts and backed by 13 RCTs, Sleepio™ for insomnia and Daylight™ for worry and anxiety are among the world’s most evidenced digital mental health solutions. These programmes seamlessly integrate into primary care, enabling clinically effective self-management of mental health. With offices in London and San Francisco, Big Health’s digital therapeutics are used by leading health systems like the NHS and large multinational employers. For more information, please visit

Big Health Media Contact:

Jess Phillips
07967 389705

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 by a medical provider, Sleepio is available as an adjunct to their usual medical care for Insomnia Disorder. Sleepio does not replace the care of a medical provider or the patient’s medication. Sleepio has not been cleared by the U.S. Food and Drug Administration (FDA) for this indication.

Disclaimer: In the UK, Sleepio and Daylight are CE marked medical devices available for the treatment of insomnia disorder and generalized anxiety disorder, respectively

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.

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. 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.

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