This paper describes the protocol for ASLEEP, a tiered, digitally delivered cognitive behavioral therapy for insomnia (CBT-I) intervention designed to reduce insomnia severity and improve related health outcomes in adults aged 50 years and older, to be evaluated via a fully digital waitlist-controlled randomized controlled trial.
Sleep difficulties are common in older adults and can negatively affect mental and physical health, cognitive function, and quality of life.
Cognitive behavioral therapy for insomnia (CBT-I) is identified as the gold-standard treatment for insomnia disorder but has limited reach due to resource demands and professional shortages.
The ASLEEP trial is designed as a fully digital, two-arm, waitlist-controlled randomized controlled trial with 400 participants aged 50 and older.
The primary outcome of the ASLEEP trial is insomnia severity measured by the Insomnia Severity Index, with secondary outcomes including sleep medication use, depression, anxiety, and cognition.
The ASLEEP project is structured in two phases: Phase 1 focuses on refining and optimizing the intervention, and Phase 2 comprises the randomized controlled trial.
The ASLEEP intervention is described as a tiered, digitally delivered CBT-I program intended to serve as a scalable, low-threshold model for insomnia prevention and treatment.
This paper describes the study design (protocol) for a clinical trial called ASLEEP, which aims to test a digital program for treating insomnia in people aged 50 and older. The program is based on cognitive behavioral therapy for insomnia (CBT-I), which is currently the best-proven treatment for sleep problems but is difficult for many people to access because it requires trained therapists and significant time. By delivering CBT-I through an online platform, the researchers hope to make effective insomnia treatment available to many more people, particularly in Norway where such digital tools are currently limited. The trial will enroll 400 adults aged 50 and older and randomly assign them either to receive the digital CBT-I program or to a waitlist (meaning they will receive the program later). Participants will be followed up at 3, 6, 12, and 15 months to see whether those who received the program early had better outcomes in terms of sleep, mental health, and thinking abilities compared to those still waiting. The trial is fully digital, meaning participants can take part from home without visiting a clinic, and it will run within an existing online research platform called PROTECT Norge. As of early 2026, the study was in its preparation phase, with the actual trial expected to begin recruiting participants after the design phase is complete and ethics approval is obtained. This research suggests that if the ASLEEP program proves effective, it could offer a practical, scalable way to help large numbers of older adults improve their sleep without needing face-to-face therapy. This matters because poor sleep in midlife and older age is linked to a range of health problems including depression, anxiety, and cognitive decline. A fully digital, widely accessible treatment option could have broad public health benefits, particularly as populations age and demand for mental health and sleep-related care continues to grow.
Aakre J, Bjorvatn B, Gjestsen M, Dalen I, Ballard C, Testad I. (2026). Preventing and Treating Insomnia Symptoms in Midlife and Older Adults (ASLEEP): Protocol for a Randomized Controlled Trial Using the PROTECT Norge Infrastructure.. JMIR research protocols. https://doi.org/10.2196/81542