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Comparison of Multimodal Delivery of Cognitive Behavioral Therapy for Insomnia in Middle Aged Adults: A Randomized Clinical Trial Design and Methodology
Published online by Cambridge University Press: 07 March 2025
Abstract
The recommended first-line treatment for insomnia is cognitive behavioral therapy for insomnia (CBTi), but access is limited. Telehealth- or internet-delivered CBTi are alternative ways to increase access. To date, these intervention modalities have never been compared within a single study. Further, few studies have examined a) predictors of response to the different modalities, b) whether successfully treating insomnia can result in improvement of health-related biomarkers, and c) mechanisms of change in CBTi. This protocol was designed to compare the three CBTi modalities to each other and a waitlist control for adults aged 50-65 years (N = 100). Participants are randomly assigned to one of four study arms: in-person- (n=30), telehealth- (n=30) internet-delivered (n=30) CBTi, or 12-week waitlist control (n=10). Outcomes include self-reported insomnia symptom severity, polysomnography, circadian rhythms of activity and core body temperature, blood- and sweat-based biomarkers, cognitive functioning, and magnetic resonance imaging.
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- This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
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- © The Author(s), 2025. Published by Cambridge University Press