Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 13, 2025
Date Accepted: Jan 20, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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
ABSTRACT
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.
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Copyright
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