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. 2025 Jul 19;8(1):458.
doi: 10.1038/s41746-025-01847-0.

A randomized controlled trial of a digital cognitive behavioral therapy for insomnia for older adults

Lee M Ritterband  1 , Kelly M Shaffer  2 , Frances P Thorndike  3 , Philip I Chow  2 , Linda Gonder-Frederick  2 , Karen S Ingersoll  2 , Wendy F Cohn  4 , Christina Frederick  2 , Kirsten MacDonnell  2 , Jillian V Glazer  2 , Meghan K Mattos  5 , Michelle M Hilgart  2 , Mark S Quigg  6 , Mudhasir Bashir  7 , Charles M Morin  8
Affiliations

A randomized controlled trial of a digital cognitive behavioral therapy for insomnia for older adults

Lee M Ritterband et al. NPJ Digit Med. .

Abstract

Older adults with insomnia face considerable challenges accessing treatment given limited availability to first-line therapy (Cognitive-Behavioral Therapy for Insomnia, CBT-I). This study evaluated the efficacy of Sleep Healthy Using the Internet for Older Adults Suffering with Insomnia and Sleeplessness (SHUTi OASIS), a tailored CBT-I internet intervention for older adults with insomnia, in a 3-arm randomized controlled trial (SHUTi OASIS alone, SHUTi OASIS + stepped support, online patient education [PE]). 311 participants (ages 55-95) were randomized to receive SHUTi OASIS (alone n = 105; with stepped support n = 102), with both conditions reporting significant improvements across post, 6-month, and 12-month follow-ups in insomnia severity compared to those receiving PE (n = 104). Clinically meaningful indices of insomnia response and remission were also higher among those receiving SHUTi OASIS. Those who received SHUTi OASIS also significantly outperformed those receiving PE on secondary outcomes, including sleep onset latency, wake after sleep onset, sleep efficiency, number of awakenings, sleep quality, and fatigue, across most timepoints. Results indicate that digital CBT-I provides important benefits for older adults, offering strong potential to expand access to insomnia treatment for this underserved population.

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Conflict of interest statement

Competing interests: K.M.S., P.I.C., K.S.I., W.F.C., C.F., K.M., J.V.G., M.K.M., M.M.H., M.S.Q. and M.B. have no financial conflicts of interest to report. L.M.R., F.P.T., L.G.-F. and C.M.M. report having equity ownership in BeHealth Solutions, L.L.C., the company that was originally established to make available digital health products, including Sleep Healthy Using the Internet, now licensed by Nox Health. F.P.T. is an employee of Nox Health, which owns the IP of Somryst, a commercial PDT for insomnia based on the SHUTi program. L.M.R. and C.M.M. are paid consultants of Nox Health. C.M.M. has also served on advisory boards for Eisai, Merck, and Phillips; served as consultant for Eisai, Merck, Sunovion, and Weight Watchers; received research support from Eisai, Idorsia, Canopy Health, and Lallemand Health. These companies had no role in the preparation of this manuscript. The terms of these arrangements have been reviewed and approved by the University of Virginia in accordance with its policies.

Figures

Fig. 1
Fig. 1. SHUTi OASIS Trial CONSORT Chart.
*Note: Number of interest forms received (1487) does not include 281 forms received after recruitment was closed, which were included in Glazer et al. (2020).
Fig. 2
Fig. 2. Primary sleep outcomes.
*Note: Total participants and raw means (SDs) are shown beneath each time point, followed by within-group effects for each time point from baseline to each postassessment and follow-up.
Fig. 3
Fig. 3. Changes in sleep medication.
The first panel is the percentage of medicated nights. The second panel is the percentage of equal to or greater than one medicated night.
See this image and copyright information in PMC

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