Digital sleep program, Sleepio, associated with significant improvements in depressive symptoms in a new research study
The effects of the digital therapeutic Sleepio1 may extend to depressive symptoms, according to new research published today in the Journal of Sleep Research.
In the largest ever study examining the effects of a fully-automated digital sleep improvement program based on cognitive behavioural techniques (Sleepio) on insomnia and depressive symptoms, researchers found that use of Sleepio improved not only insomnia symptoms, but also depressive symptoms in individuals with insomnia and clinically significant depressive symptoms. Further analyses revealed a significant proportion of the improvements in depressive symptoms were caused by the improvements in sleep.*
The study included 3,352 participants and was a sub-analysis of data from two large effectiveness trials of Sleepio. The original trials investigated the effects of Sleepio on physical health and functioning and on mental health, respectively. In each case, study participants received digital cognitive behavioral techniques using Big Health’s Sleepio program.
1 In the US, Sleepio has not been cleared by the FDA for use in diagnosis or treatment of a disease or condition, such as Insomnia Disorder, Generalized Anxiety Disorder or Major Depression Disorder.
The findings revealed that:
- Sleepio was associated with significant improvement not only in sleep, but also in mental health. Those using Sleepio experienced clinically meaningful and statistically significant reductions in depressive symptoms compared to the control group 8-10 weeks after intervention, with these effects maintained at 22-24 weeks after intervention
- Participants using Sleepio were almost 3 times more likely to no longer experience clinically significant depressive symptoms compared to control participants at post-intervention
- Improvements in sleep – as a result of using Sleepio – were responsible for causing 87 percent of the improvement in depressive symptoms
The findings of this latest research suggest that the effects of Sleepio are not limited to sleep and may also extend to improving co-occurring depressive symptoms. According to the researchers, addressing sleep problems in individuals with co-occurring depressive symptoms may increase the odds of depressive symptom resolution by a factor of 2.4 to 3 times.
Commenting on the findings, lead researcher and Research Manager at Big Health, Dr Alasdair Henry, said:
“Our study suggests that evidence-based digital therapeutics for sleep could be a powerful way to help millions of people not just sleep better, but also improve their depressive symptoms.
“In clinical studies, Sleepio has repeatedly achieved statistically significant and clinically meaningful improvements in sleep and mental health. Our latest results indicate that Sleepio can be an effective way to help those experiencing insomnia and clinically significant depressive symptoms achieve better outcomes over the long term through evidence-based cognitive and behavioural techniques. ”
Professor of Clinical Psychology at the University of Oxford, Daniel Freeman, added:
“Depressive symptoms can be associated with significant stigma, which can prevent people from seeking help. These results show that addressing sleep may be an effective option for improving depressive symptoms, potentially providing a less stigmatized route to addressing broader mental health.
“Digital programs like Sleepio overcome many of the barriers associated with accessing other forms of evidence-based care and it certainly increases people’s options. It could help in filling the enormous gap that currently exists in access to mental health care around the globe, and is particularly urgent during the current pandemic, when even access to routine care is disrupted.”
With this study publication, Sleepio is the subject of 40 published papers in the clinical literature, including 12 randomised controlled trials (RCTs).
* Research supported by experts from Big Health; the Sleep and Circadian Neuroscience Institute at Nuffield Department of Clinical Neurosciences, University of Oxford, UK; the Department of Biostatistics and Health Informatics at King’s College London, UK; the Department of Psychiatry at the University of Oxford, UK; the Department of Epidemiology at Erasmus MC University Medical Centre, Rotterdam, the Netherlands; the NIHR Greater Manchester Patient Safety Translational Research Centre at the University of Manchester, UK.
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.
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