Abstract

Abstract Introduction Cognitive-behavioral therapy for insomnia (CBT-I) is the current first-line treatment for insomnia disorder, recommended by the AASM and SRS. Digital versions of CBT-I have been developed and validated to address the need for implementation at scale but still suffer from poor accessibility and compliance. Therefore, the aim of this open-label, Real-World Study (RWS) was to assess the engagement and efficacy of a next-generation CBT-i 6-weeks program. Methods 1304 subjects were included in the analysis between Dec 23rd, 2018 and December, 14th 2019. The main inclusion criteria were having an Insomnia Severity Index ISI ≥ 15 and completion of one week of Dreem program. The variables have been measured by the Dreem headband (DH) for objective variables, and on subjects’ answers to questionnaires for subjective ones. Results The retention during this RWS was 70.4 % (Pre: n = 1304 and Week 4: n = 935). The program led to a clinically significant decrease of 7.42 points on the ISI (p < 0.001). The obj-WASO was reduced by 35% (n = 359, p < 0.001), obj-Awakenings were reduced by 37% (n = 359 p < 0.001), obj-SE was increased by 2.56 points (n = 305, p < 0.001) and obj-SOL was reduced by 22% (n = 359, p < 0.001). The subj-SOL was reduced by 41% (n = 176, p < 0.001), subj-SE was increased by 8.9 points (n =168, p < 0.001), subj-SD was increased by 16% (baseline: 307.50 ± 88.86 min; post 357.07 ± 91.24 min, subj-SD (n = 174, p < 0.001). Conclusion The results of this RWS suggest this insomnia program has a high engagement compared to other digital CBT-I programs and is as effective as traditional in-person CBT-I. This new generation of Insomnia therapy combining hardware, software and therapist serves as an efficient and engaging treatment implementable at scale. Support This study has been supported by Dreem sas.

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