Abstract Introduction A stepped-care model going from digital cognitive behavioral therapy for insomnia (dCBT-I) to clinician-led CBT-I (fCBT-I) has been shown to be acutely effective. However, the sustainability of the effects over longer periods of time has not yet been examined. This study tested the durability of treatment effects of this stepped-care approach two years following the end of treatment. Methods 1018 individuals with insomnia (DSM-5 diagnostic criteria) were randomized into two conditions at step 1: dCBT-I (N=613), or an online sleep education control (N=624). Participants in the dCBT-I condition who did not remit (ISI>9) were further randomized to either face-to-face CBT-I (N=103) or sleep education (N=104). Insomnia remission and treatment gains at 2-year follow-up were compared across treatment conditions. Results Among step-1 non-remitters, odds of insomnia remission for those who stepped-up to fCBT-I was almost three times higher (60% in remission) than those who received the step-2 control (33% in remission), OR = 2.95, 95% CI [1.3, 6.7]. Odds of remission was not significantly different between those who remitted at step-1 (64% in remission at year 2) and those who received fCBT-I, OR = 3.53, 95% CI [1.7, 7.5]. The treatment gains were higher in the fCBT-I group (9.6 point improvement from baseline) compared to those who remitted at step-1 (7.7 point improvement from baseline) (Cohen’s d = 0.44). Conclusion Preliminary evidence indicate that the treatment effects of this stepped-care model are durable two years after treatment. Support (if any) Support for this study was provided from the National Institute of Mental Health R56MH115150 and R01MH122636 awarded to Dr. Christopher Drake.
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