Effects of Digital Cognitive-Behavioral Therapy for Insomnia in a Tailored Program for Older Adults: Randomized Controlled Trial with One-year Follow-Up

Background: Older adults with insomnia face considerable challenges accessing treatment given limited availability to first-line therapy (cognitive-behavioral therapy for insomnia, CBT-I) and risks related to second-line treatment (pharmacotherapy).Objectives: Evaluate the efficacy of Sleep Healthy Using the Internet for Older Adults Suffering with Insomnia and Sleeplessness (SHUTi OASIS), a tailored CBT-I program for older adults with insomnia delivered via the Internet. Design: Randomized controlled trial with three conditions (SHUTi OASIS, SHUTi OASIS + stepped support, online patient education [PE]).Setting: Remotely conducted trial in the United States.Participants: Older adults with chronic insomnia (age range 55 to 95).Methods: 311 participants were enrolled and completed assessments of self-reported questionnaires, including the Insomnia Severity Index, and 10 prospectively-collected online sleep diaries at baseline, post (after 9-week intervention period), 6-month post, and 12-month post.Results: Participants randomized to receive SHUTi OASIS (n=207; conditions collapsed given limited need of stepped support) were compared to those receiving PE (n=104). SHUTi OASIS significantly outperformed PE with overall group by time interactions for the primary outcome of insomnia severity (F3,779=30.61, p<.001), as well as for sleep onset latency (F3,774=6.15, p<.001) and wake after sleep onset (F3,778=11.13, p<.001), with participants receiving SHUTi OASIS showing greater improvements at post, 6-months post, and 12-months post. Clinically meaningful indices of insomnia response and remission were also higher among SHUTi OASIS participants compared to PE participants. Conclusion: Older adults can meaningfully benefit from online CBT-I, which holds significant promise to increase access to effective insomnia treatment among this underserved population.