ArticleThe Lancet regional health. Europe2026
Long-term clinical and cost-effectiveness of a fully automated digital cognitive behavioural therapy for insomnia: 2-year follow-up of a single-blind, superiority, randomised controlled trial.
Article in The Lancet regional health. Europe, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02558647 (Overcoming Insomnia), which is not on this map. Not yet cited in PubMed.
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Overcoming Insomnia: A Large-scale Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia Compared With Online Patient Education About Sleep.
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13 authors.
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Abstract
Background: We evaluated the long-term clinical and cost-effectiveness of fully automated digital cognitive behavioural therapy for insomnia (dCBT-I) or online patient education (PE) in the Norwegian general population. Methods: A parallel-group, participant-blinded, superiority randomised controlled trial in self-referred adults with significant insomnia symptoms (Insomnia Severity Index [ISI] ≥12). Participants completed automated screening prior to randomisation and outcomes were assessed over 2 years. The primary outcome (9-week clinical effectiveness) has been published. We now report intention-to-treat analyses from the 6-month and 2-year follow-ups. Incremental cost-effectiveness ratio (ICER), with non-parametric bootstrapping, summarized the between-group societal costs in 2019 Euros, and quality-adjusted life years (QALYs). The trial was preregistered at ClinicalTrials.gov (NCT02558647) and followed a prespecified protocol. Findings: 1720 participants (1167 [67.8%] female; mean age 44.4) were randomised between February 26, 2016, and July 1, 2018 (867 to dCBT-I vs. 853 to PE). The final follow-up included 587/1720 (34.1%) participants (dCBT-I = 315; PE = 272), a median of 28.3 months (IQR 22.6 to 34.0) after baseline. At 2-year follow-up the mean ISI was 10.7 (SD 5.9) in the dCBT-I group and 13.4 (5.9) in the PE group (estimated difference: -1.77 [95% CI: -2.65 to -0.90]; Cohen's Interpretation: Compared with online PE, fully automated, low-threshold dCBT-I demonstrates greater short-term (9 week) and longer-term improvements (≥2 years) in insomnia severity and is likely cost-effective over the 2-year horizon. However, effects attenuated over time and long-term certainty is limited by attrition. Funding: Norwegian Council of Research; Liaison Committee for Education, Research and Innovation in Central Norway.
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