ASLEEP: Preventing and Treating Symptoms of Insomnia in Mid-Life and Older Adults – Study protocol for a Randomized Controlled Trial on the PROTECT Norge Infrastructure (Preprint)

BACKGROUND Sleep is increasingly recognized as a fundamental determinant of health and brain function. Sleep difficulties are common in older adults, with a substantial proportion reporting problems initiating or maintaining sleep, which can negatively impact mental and physical health, cognitive function, and quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is the gold-standard treatment for insomnia disorder, but its reach is limited due to resource demands and a shortage of professionals that can deliver it. eCBT-I via eHealth platforms increase accessibility and have demonstrable effects- but remains limited in many countries. OBJECTIVE The objective of this paper is to describe the protocol for the further development and evaluation of ASLEEP (Preventing and Treating Insomnia in Mid-Life and Older Adults), a tiered, digitally delivered CBT-I intervention designed to reduce insomnia severity and improve related health outcomes in adults aged 50 and above. METHODS The project will be conducted in two phases. Phase 1 focuses on refining and optimizing ASLEEP, developing an advanced CBT-I course, and integrating it into PROTECT Norge, a fully automated digital research platform. Phase 2 is a fully digital, two-arm, waitlist-controlled randomized controlled trial (RCT) with 438 participants randomized 1:1 to intervention or waitlist control, with allocation stratified by age and insomnia severity. Outcomes will be assessed at baseline, 3, 6, and 12 months, with a 15-month follow-up for the waitlist group. The primary outcome is insomnia severity measured by the Insomnia Severity Index (ISI); secondary outcomes include sleep medication use, depression, anxiety, and cognition. RESULTS This protocol outlines the next steps in optimizing and evaluating ASLEEP, a scalable digital CBT-I intervention for mid-life and older adults. By leveraging PROTECT Norge’s infrastructure, this study will assess the potential of digital CBT-I to improve sleep and medication use and improve mental and cognitive health outcomes in ageing populations. CONCLUSIONS This trial will evaluate the short- and long-term effectiveness of a, tiered digital CBT-I intervention for mid-life and older adults. By leveraging the PROTECT Norge platform and if effective, ASLEEP may represent a scalable model for low-threshold, accessible prevention and treatment of symptoms of insomnia.