Does treating insomnia with digital cognitive behavioural therapy (Sleepio) mediate improvements in anxiety for those with insomnia and comorbid anxiety? An analysis using individual participant data from two large randomised controlled trials.

Background: Considerable comorbidity exists between insomnia and anxiety, and evidence shows that the benefits of CBT for insomnia extend to anxiety. Using data from two large trials of digital CBT (dCBT) for insomnia, we evaluated whether improving sleep is an effective treatment target to reduce both insomnia and anxiety symptoms in individuals with insomnia and clinically significant anxiety.
Methods: This was a controlled sub-analysis combining individual participant data from two previous randomised controlled trials of dCBT for insomnia (Sleepio). Participants (N = 2172) with insomnia disorder and clinically significant anxiety symptoms were included in this sub-analysis and received either dCBT or control (usual care or sleep hygiene education). Assessments were evaluated at baseline, post-intervention (week 8 or 10), and follow-up (week 22 or 24). Mediation was evaluated using structural equation models.
Results: dCBT for insomnia was superior to control at reducing both insomnia (Hedges' g range = 0.77-0.81; both p < 0.001) and anxiety symptoms (Hedges' g range = 0.39-0.44; both p < 0.001) at all time points. Baseline insomnia symptoms moderated the effects of dCBT on insomnia, however no variables moderated treatment effects on anxiety. Reductions in anxiety symptoms at follow-up were mediated by improvements in sleep at post-intervention (% mediated = 84 %), suggesting a causal pathway.
Limitations: Participants did not have a formal anxiety disorder diagnosis and so the effects of dCBT for insomnia on anxiety may differ by anxiety disorder.
Conclusions: Addressing sleep using dCBT for insomnia may serve as a treatment target from which to improve anxiety in individuals with insomnia and clinically significant comorbid anxiety.
Clinical Trial Registrations: Digital Insomnia therapy to Assist your Life as well as your Sleep (DIALS) - ISRCTN60530898 http://www.isrctn.com/ISRCTN60530898. Oxford Access for Students Improving Sleep (OASIS) - ISRCTN61272251 http://www.isrctn.com/ISRCTN61272251.
Competing Interests: Declaration of competing interest The authors declare no Competing Non-Financial Interests but the following Competing Financial Interests. ALH is employed by Big Health Ltd. (Sleepio), receives a salary and is a shareholder. CBM, is employed by Big Health Ltd. and is salaried by the company. CAE is the Co-Founder and Chief Scientist of Big Health Ltd. and is a shareholder, and is salaried by the company. BS offered clinical consultancy to Big Health Ltd. during the course of the OASIS trial. RE is a paid consultant of Big Health Ltd. AIL held a position at the University of Oxford funded by Big Health Inc. when the DIALS trial was being conducted. The digital CBT intervention was made available to all participants at no cost. No other investigators report conflicts of interest. Both original studies were conducted at the University of Oxford, Sleep & Circadian Neuroscience Institute and Department of Psychiatry.
(Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)