Big Health’s digital therapeutic Sleepio may not only improve insomnia but also reduce symptoms of depression, a study to be published Aug. 19 in the Journal of Sleep Research shows.

Sleepio is a fully automated digital sleep improvement program designed to relieve insomnia using the precepts and constructs of cognitive behavioral therapy (CBT). San Francisco-based Big Health also has a CBT-based digital therapeutic for generalized anxiety disorder called Daylight.

“Within the field of psychology, there’s been a longstanding understanding of a link between sleep issues and depressive symptoms,” lead researcher Alasdair Henry, research manager at Big Health and honorary research fellow (research psychologist in insomnia and sleep medicine) at the University of Oxford, UK, told BioWorld. “Having an underlying sleep problem doubles the risk of low mood and depressive issues. We had seen an improvement in the area of mood in Sleepio studies, so we looked more deeply at the relationship between clinical insomnia and depressive symptoms in this study.”

Improvement in depression symptoms

The study found that participants who used Sleepio experienced improvement in sleep and statistically significant reductions in depressive symptoms compared to those in the control groups, and the improvements were maintained at six months. Participants using the digital therapeutic were also three times more likely to no longer experience clinically significant depressive symptoms than those in the control group at the post-intervention assessment.

The researchers also found that improvement in sleep measured at mid-intervention predicted improvement in depressive symptoms at the end of the intervention. Further, improvement in sleep was responsible for 87% of the improvement in depressive symptoms.

“We’re seeing here that in a group with clinically significant problem, the benefits go beyond sleeping better to improve mood. This could provide a therapeutic pathway to addressing mental health issues with less stigma,” Henry said.

Addressing sleep problems in individuals who also have depression may increase the odds of resolving depressive symptoms by a factor of 2.4 to 3.0 times, the researchers said.

“More often than not, people with sleep issues will have issues with low mood,” Henry noted. “When they’re speaking with friends or colleagues, people are more responsive to someone talking about having a bad night’s sleep than feeling down for a bit, so this could have wider impact on mental health issues as well.”

If supported by future research, accessing cognitive behavioral therapy to mitigate sleep issues through a digital therapeutic could help millions of people manage or resolve their depression and do so in a way that avoids the stigma often associated with seeking help for mental health issues.

“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,” said Daniel Freeman, professor of clinical psychology at the University of Oxford. “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.”

In many parts of the U.S. and elsewhere, clinicians with training in CBT are hard to find or have long wait lists for patients. Many individuals also find that insurance limits the number of therapy visits covered in a year.

Sleepio is currently available in the U.S. through some employer-based benefit programs. Individuals may also access the program through participation in research studies.

The study

The study aggregated participants from two previous effectiveness trials of Sleepio and then analyzed the effect of the program on the subset of participants who had clinical depression in addition to clinically significant insomnia.

Both trials used validated measures for both insomnia (SCI-8) and depression (PHQ-9) for all participants at baseline, post-intervention (eight to 10 weeks after initiation), and at follow up (22 to 24 weeks after the start of the program). Three out of five participants in the trials met the criteria for clinical depression, a PHQ-9 score of 10 or higher, resulting in 3,352 participants being included in the analysis. Participants with depression were split almost evenly between the intervention (1,696) and control groups (1,656). Both groups were similar in demographics and clinical characteristics.

“In clinical studies, Sleepio has repeatedly achieved statistically significant and clinically meaningful improvements in sleep and mental health,” said Henry. “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 behavioral techniques. ”

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