What question did this study set out to answer?

This research aims to evaluate the long-term clinical and cost-effectiveness of a fully automated digital cognitive behavioral therapy for insomnia compared to online patient education.

May 11, 2026Open Access

बिना किसी मानव हस्तक्षेप के insomnia के लिए पूर्ण स्वचालित डिजिटल संज्ञानात्मक व्यवहार थेरेपी की दीर्घकालिक नैदानिक और लागत-प्रभावशीलता: एक एकल-धुंधला, सर्वोत्तमता, यादृच्छिक नियंत्रित परीक्षण का 2-वर्षीय अनुवर्ती

Key Points

This research aims to evaluate the long-term clinical and cost-effectiveness of a fully automated digital cognitive behavioral therapy for insomnia compared to online patient education.
Conducted a parallel-group, participant-blinded, superiority randomized controlled trial
Included 1720 self-referred adults with insomnia symptoms, followed over two years
Primary outcome assessed was insomnia severity index and cost-effectiveness using incremental cost-effectiveness ratio
At 2-year follow-up, mean insomnia severity index was significantly lower in the dCBT-I group (10.7) compared to the PE group (13.4), with a difference of -1.77 (95% CI: -2.65 to -0.90)
The dCBT-I group reported lower costs with an estimated ICER of -10,973 per QALY gained, showing 94% probability of cost-effectiveness at 0 willingness-to-pay
No harms or adverse events reported during the trial

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 followups.Incremental cost-effectiveness ratio (ICER), with non-parametric bootstrapping, summarized the betweengroup 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 d= -0.43).The dCBT-I group reported -278 95% CI: -1413 to 858 lower costs and 0.025 QALYs gained 95% CI: 0.010 to 0.041 compared with PE, yielding a 94% probability of cost-effectiveness at 0 willingness-to-pay (ICER: -10,973 per QALY gained).No harms or adverse events were reported.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.

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