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.

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%] 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. 

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

The study

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. 

The IAPT programme

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. 

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.
1 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.