1100 Digital CBT-I is Associated with Meaningful, Sustained Reductions in Depression and Anxiety Among those with Clinically Significant Baseline Symptoms

Abstract Introduction Previous randomized controlled trials have found that Cognitive-Behavioral-Therapy for Insomnia (CBT-I) can have anti-depressant and anxiolytic effects for people with insomnia and comorbid depression/anxiety. However, it is unclear if these findings can generalize to real-world delivery of digital CBT-I. Moreover, it is unknown if these effects are sustainable in the real world. The purpose of this study is to examine real-world evidence of the long-term impact of dCBT-I on mood and anxiety symptoms among individuals with insomnia and clinically significant depression/anxiety at baseline. Methods Data were derived from a large real-world analysis of dCBT-I (Somryst, DREAM trial). The validated PHQ-8 and GAD-7 questionnaires were collected at baseline, post-treatment, and for up to two years. Patients were stratified by baseline depression and anxiety severity (separately). All available endpoints were evaluated using a mixed-model repeated measures analysis with study visit as a fixed effect and subject as a random intercept. Results Patients with severe anxiety at baseline (mean GAD-7 score=17.5; SE=0.20) experienced large, clinically meaningful improvements in anxiety at post-treatment (mean score=10.6; SE=0.22; Cohen’s d=1.68) and 2-year follow-up (mean=10.8; SE=0.82; d=1.35); p< 0.0001. Patients with severe depression at baseline (mean PHQ-8 score=21.6; SE=0.31) experienced similarly large improvements at post-treatment (mean=13.0; SE=0.33; d=1.93) and 2-year follow-up (mean=12.5; SE=1.43, d=1.53); p< 0.0001. Improvements were less pronounced for patients with mild anxiety (baseline mean GAD-7 score=6.8 [SE=0.18]; post-treatment mean=5.2 [SE=0.19]; d=0.59) and mild depression (baseline mean PHQ-8 score=7.1, SE=0.20; post-treatment mean=5.1, SE=0.21; d=0.82. Among patients with mild anxiety and depression at baseline, no statistically significant improvements were observed at two years. Conclusion dCBTI improved depression and anxiety among individuals with comorbid insomnia and clinically significant depression and anxiety at baseline. The largest improvements were observed among individuals with severe depression and/or anxiety at baseline. Patients with mild depression and/or anxiety did not experience the same benefit. Support (if any) This study was initially funded by Pear Therapeutics and later funded by Nox Health who supported analysis and writing of this abstract.