Digital CBT Tool Sleepio Improves Sleep in Patients Undergoing Poststroke Rehabilitation

Colin Espie, PhD

Recently, data from a study conducted at the University of Oxford utilizing the Sleepio digital therapeutic for the treatment of insomnia suggested that the program can improve sleep for patients undergoing poststroke rehabilitation. The preliminary findings showed that about 50% of those using the intervention reported a clinical improvement in sleep, while further analysis suggested that it also improved depression and anxiety at 8-weeks post initiation.¹

Current guidelines, including those from the National Institute for Health and Care Excellence (NICE) and the American Academy of Sleep Medicine, recommend cognitive behavioral therapy (CBT), which is largely incorporated into the Sleepio program, as firstline treatment for insomnia.^2,3 Big Health noted in its announcement of the data—presented at the European Stroke Organisation (ESO) conference, May 4-6, in Lyon, France—that expanding access to include a poststroke population can aid sleep conditions and support recovery for patients.

“Sleepio delivers CBT through a fully automated software platform on web and mobile. Basically, CBT is a guideline treatment for insomnia—the most common sleep problem—because what CBT does is addresses the two things that really are responsible for persistent sleep difficulties,” Colin Espie, PhD, cofounder and chief scientist, Big Health, and professor of sleep medicine, University of Oxford, told NeurologyLive^®. “One is the racing mind. We all know what it's like when we can't get to sleep when our mind is full and busy. And secondly, when we can't get our sleep into pattern, that's the behavioral element of it. CBT is a guideline treatment for insomnia associated with any condition—rather than medication. And, of course, in the case of people with who've had stroke, one would ideally prefer to use a nonpharmacological intervention in any case because these individuals have probably got a raft of medications and other treatments that they require.”

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This is not the first time Sleepio has shown promise for improving sleep for individuals with difficulties with it. Previously, in a cohort of patients with insomnia, the use of Sleepio was associated with clinical improvement in 76% of patients.¹ Additional results from a Markov model analysis suggest that the digital CBT is the most cost-effective treatment for insomnia, particularly in comparison to group CBT, pharmacotherapy, and individual CBT.⁴ Ultimately, those findings showed that in comparison to no insomnia treatment, with a net positive monetary benefit of $681.06 every 6 months per individual, confirmed by bootstrap sensitive analysis in 94.7% of simulations. In comparison to the other 3 insomnia treatments, the digital CBT intervention offered the smallest incremental cost-effectiveness ratio, of –$3124.73.⁴

In another trial of more than 200 patients, this digital CBT platform was deemed effective, safe, and acceptable by investigators as an intervention for insomnia symptoms in pregnant women. Additionally, the insomnia therapy, consisting of 6 weekly, 20-minute sessions, appeared to be scalable to a larger population of patients. Those randomized to digital CBT (n = 105) experienced significantly greater improvement in insomnia symptoms, as measured by the total score on the 7-item syndromal measure Insomnia Severity Index, compared to those who received standard treatment (n = 103), for a difference of −0.36 (95% CI, −0.48 to −0.23; χ², 29.8; P <.001; d = −1.03).⁵

“What may surprise people about the study is that when people have had a major medical event, like a stroke, it's quite easy to think, ‘Oh, well, that's the primary thing, that's the thing we should really be worrying about. Everything else is kind of peripheral or secondary to that,’” Espie explained. “But the reality is that, that people are trying to get back to live their lives in their own homes, their own situations, struggling with the patterning of their sleep that may have changed because of the stroke and gotten worse. And, of course, anxiety is on their mind. This is why CBT for insomnia, including this population seemed totally appropriate.”

Stroke, as Big Health noted in its announcement, is often accompanied by sleep disruptions that can occur throughout the rehabilitation process. A 2019 study published in Stroke suggested that roughly 50% of stroke survivors have insomnia, implying a need for improvement in sleep for poststroke recovery.⁶ Existing research has demonstrated that quality sleep can improve recovery-specific tasks, such as muscle movements, strength, and motor functions.

Lead author Melanie K. Fleming, PhD, research fellow, Nuffield Department of Clinical Neurosciences, University of Oxford, said in a statement that “based on preliminary outcomes, [CBT] should be considered as part of the multidisciplinary care pathway after stroke. This study indicates the ability for digital therapeutics to effectively expand access to cognitive behavioral therapy and improve health outcomes for people with comorbid health conditions.”¹

REFERENCES
1. First-of-its-Kind Study Demonstrates Digital Therapeutic Significantly Improves Sleep and Mental Health for Stroke Patients. News release. Big Health. May 4, 2022. Accessed May 12, 2022. https://www.bighealth.com/news/first-of-its-kind-study-demonstrates-digital-therapeutic-significantly-improves-sleep-and-mental-health-for-stroke-patients/
2. Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017;13(2):307-349. doi:10.5664/jcsm.6470
3. Templeton L, et al. Management of Insomnia Guideline. NICE. 2021. https://mypsych.nhsggc.org.uk/media/1218/mhs-35-management-of-insomnia-guideline.pdf
4. Darden M, Espie CA, Carl JR, et al. Cost-effectiveness of digital CBT (Sleepio) for insomnia: A Markov simulation model in the United States. Sleep. 2021;44(4):zsaa223. doi:10.1093/sleep/zsaa223
5. Felder JN, Epel ES, Neuhaus J, Krystal AD, Prather AA. Efficacy of digital cognitive behavioral therapy for the treatment of insomnia symptoms among pregnant women: A randomized clinical trial. JAMA Psychiatry. 2020;77(5):484-492. doi:10.1001/jamapsychiatry.2019.4491.
6. Khot SP, Morgenstern LB. Sleep and Stroke. Stroke. 2019;50:1612-1617. doi:10.1161/STROKEAHA.118.023553