Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker: a study protocol

Background Insomnia is common in breast cancer survivors (BCS), affecting an estimated 30–50% of the 3.8 million BCS in the US. Insomnia is associated with health consequences for cardiometabolic and immune systems, neurobehavioral function, depression, fatigue, and quality of life and may put BCS at particular risk. While pharmacotherapy for insomnia may address symptoms in the short-term, cognitive behavioral therapy for insomnia (CBT-I) is considered the gold standard insomnia treatment. We describe our protocol to determine the efficacy of voice-activated delivery of CBT-I components on insomnia symptoms compared to a sleep education control among BCS. Methods We will conduct a 6-week, randomized controlled trial with two arms. Intervention arm participants will receive a smart speaker device and will be asked to engage with the program daily, using a voice-activated speaker with an accompanying smart-phone app. Control participants will have access to a website with basic information about CBT-I, sleep, and breast cancer survivorship and will be asked to engage with the website as desired. Discussion Our primary outcome is the Insomnia Severity Index total score. Secondary outcomes include sleep diary outcomes (sleep efficiency, wake after sleep onset, sleep onset latency, total sleep time, and sleep quality). This study will provide evidence on a promising modality to deliver elements of CBT-I for BCS experiencing insomnia. Trial Registration ClinicalTrials.gov NCT05233800 Released 3/25/2022.