Currently submitted to: JMIR Aging
Date Submitted: Nov 6, 2026
Open Peer Review Period: Nov 9, 2026 - Jan 4, 2027
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited.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.
Digital Cognitive Behavioral Therapy for insomnia in older adults: a secondary analysis from a population-based randomized controlled trial
ABSTRACT
Background:
Digital cognitive behavioral therapy for insomnia (dCBT-I) has demonstrated robust effects in large population-based studies. However, older adults are underrepresented in trials of fully automated dCBT-I, and evidence on treatment effects and engagement in this age group remains limited. Exploring whether the benefits of fully automated dCBT-I extend to adults aged ≥65 years, and whether older adults engage with unguided digital treatment, is important for informing the use of dCBT-I in this population.
Objective:
This study aimed to examine the effects of fully automated dCBT-I on insomnia severity, fatigue, anxiety and depression and sleep-diary outcomes among adults aged ≥65 years, and to assess their engagement with the intervention.
Methods:
We conducted post hoc secondary age-stratified analyses of data from a large population-based randomized controlled trial of dCBT-I including 1721 adults aged ≥18 years. We focused on participants aged ≥65 years who had been randomized to either a fully automated dCBT-I program (intervention group) or a patient education program (control group). Outcomes were assessed at baseline, 9 weeks, and 6 months and included the Insomnia Severity Index (ISI; primary outcome), anxiety and depression (HADS), fatigue (CFQ), and sleep-diary parameters. Treatment effects were estimated using mixed-effects models examining change over time by group. Engagement was assessed based on completion status of the six intervention modules.
Results:
A total of 139 participants were included, with a mean age of 70 years. Participants who received dCBT-I showed significantly greater reductions in insomnia severity at both 9 weeks (between-group difference -4.4, 95% CI -6.3 to -2.5; Cohen d = -1.2) and 6 months (-2.4, 95% CI -3.6 to -1.2; Cohen d = -0.7) compared to the control group. dCBT-I also led to improvements in fatigue at 9 weeks and in wake after sleep onset, early-morning awakenings, and sleep efficiency, with effects maintained at 6 months. Among participants randomized to dCBT-I, 88% completed the first module and 61% completed all six modules.
Conclusions:
Even though the program was not specifically adapted for this age group older adults aged ≥65 years benefited from fully automated dCBT-I, with clinically substantial improvements in insomnia severity and sustained improvements in several sleep-continuity outcomes. These findings support the acceptability and therapeutic potential of digital interventions in ageing populations. Clinical Trial: ClinicalTrials.gov NCT02558647; https://clinicaltrials.gov/study/NCT02558647
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