0441 Sleep Disturbance in MCI: A Pilot Study of a Cognitive Behavioural Therapy Digital Intervention (SUCCEED)

Abstract Introduction Insomnia is common in older adults with mild cognitive impairment (MCI) and predicts future cognitive decline. Cognitive Behavioural Therapy for insomnia (CBT-I) is the first-line treatment for insomnia but is often unavailable. We tested the feasibility of a randomised controlled trial comparing 12-weeks of digital CBT-I vs wait-listed control in older adults with MCI and insomnia. Methods This was an investigator-initiated (NCT05568381), parallel open-label randomised-controlled feasibility trial. Participants were randomised to digital CBT-I (Sleepio, 6-weekly sessions) or a wait-listed control (3 fortnightly online modules of a sleep health education package) via a secure centralised platform which was also used to collect the outcome data. This study was undertaken remotely without in-person visits. Potential participants were recruited through online advertising and a memory clinic in Sydney, Australia. Those who met initial eligibility were invited to a screening and informed consent telehealth consultation. Inclusion criteria included adults aged ≥50 years, with an Insomnia Severity Index (ISI)10, who met the clinical criteria of MCI on a neuropsychological battery (performed over telehealth for participants recruited online). The primary outcomes were the proportion of participants who met screening and randomisation criteria. A secondary outcome was the effect sizes and 95%CIs of the difference in ISI between the groups at week 12. Results Recruitment occurred March 23, 2023 to August 11, 2023 stopping when we reached our pre-defined sample size (digital CBT-I=19; control=21; 30 females; mean SD age=59.7 years 7.3; ISI=17.0 3.7). 37% of participants issued a pre-screening number (n=246), were eligible to attend online screening. 47% of those issued a screening number (n=90) were eligible to be randomised (n=42). All randomised participants (n=40) were recruited through the online pathway. At 12-weeks there was a difference in ISI between the digital CBT-I (mean±SE 7.8±1.1 points) and control groups (13.7±1.05 points) (Cohen’s D 95%CI -1.6 -2.4 to 2.1). 79% of participants completed ≥4 out of the CBT-I 6 sessions. All adverse events were minor and transient. Conclusion This population can be recruited through online pathways and follow the protocol as well as adhere to the intervention of this remotely conducted trial. Support (if any) CogSleep CRE Seed Funding Grant. BigHealth- intervention in-kind.