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.