0397 Randomized Controlled Trial of Telehealth in Older Adults: Technology-assisted CBTi+, CBTi, and Sleep Hygiene

Abstract Introduction Of 34M US adults affected by insomnia, 75% are older adults. Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended because polypharmacy and fall risks accompany pharmacotherapies. We evaluated telehealth CBTi with an interactive patient-therapist application, SleepSpace, which integrates data from wearables and Internet of Things (IoT) devices. Methods This RCT (NCT05015803) followed community-dwelling participants 60-90 years old with an Insomnia Severity Index (ISI) score ≥11. Absence of mild cognitive impairment was affirmed with the Montreal Cognitive Assessment (MoCA) Blind v.8 (score ≥ 18). Participants wore actigraphy and an Apple Watch throughout and independently completed a weekly electronic ISI. They attended 7 weekly, ~1hr video-conference sessions (1 intake, 6 procedural) with a clinical therapist. Participants were randomly assigned to one of 3 study conditions (age-, gender-stratified): 1) education about sleep hygiene only (20%; “Hygiene”), 2) telehealth CBTi (40%; “CBTi”), and 3) telehealth CBTi with phone/IoT platform application enhancement (40%; “CBTi+”) including meditations, sound machines, smart light bulbs, an electronic diary, with visualizations, metrics, and wearable data shared with participants in the CBTi+ condition. Linear mixed models compared ISI change across time by group. Results Of 60 individuals enrolled, 54 were randomized and retained (39F, mean±SD age=71±4y). ISI slopes for both CBTi (-.09/day) and CBTi+ (-.09/day) declined at a significantly steeper rate than Hygiene (-.05/day; each p.05), but did not differ from one another. Significantly more CBTi+ participants exhibited full remission (ISI 8; 18/21, 85.7%) than in the Hygiene group (5/11, 45.4%; p=.03 Fisher’s Exact); CBTi alone (16/22, 72.7%) did not significantly differ from Hygiene, although with limited statistical power. Diary-reported sleep measures to calculate self-reported sleep efficiency (sSE) in the final week at end of treatment revealed differences in mean±SD for Hygiene (81±05%) vs. CBTI (88±07%), and vs. CBTI+ (90±04%, p 0.05, t-test). Conclusion This research supports the efficacy of a remote, technology-assisted telehealth CBTi platform to improve insomnia symptoms comparable to standard telehealth-CBTi in older adults with insomnia. The platform provides enhanced data access for therapists and opportunities for data-driven engagement with patients. Support (if any) R44 AG056250, UL1TR002014