App-guided bedtime mindfulness for insomnia

PROJECT SUMMARY This K23 award will support the candidate’s training and development towards an independent clinical research career focused on behavioral sleep medicine and the use of remote technology-based delivery/assessment of mindfulness meditation (MM) to facilitate self-sleep management in patients with chronic insomnia disorder. BACKGROUND. Insomnia is highly prevalent and associated with a wide range of deleterious health consequences. According to well-established disease models, insomnia is characterized by bedtime stress, pre-sleep hyperarousal, or high sleep reactivity. MM is a promising intervention for patients with insomnia. The delivery of MM via mobile health has largely increased access to such interventions. Technology has allowed both remote delivery of intervention and home assessment with physiological recordings that increase access to real-world data. Existing studies have mostly focused on daytime MM practice and subjective sleep quality at night. It is not clear whether the temporal relationship of bedtime MM practice is important to sleep outcomes, what is the most effective way to deliver app-based MM for patients with insomnia disorder, or whether physiological changes correlated with mindfulness practice contribute to sleep improvement. SPECIFIC AIMS. This K23 proposes a proof-of-concept feasibility study with aims to: (1) refine content delivery of an app-based MM intervention (specifically for bedtime use); (2) evaluate the feasibility and acceptability of the app-based intervention in a pilot randomized controlled trial; and (3) explore patterns of change in sleep-related subjective/objective outcomes, including remote assessment. TRAINING. To develop expertise critical to the candidate’s overall career goals, Dr. Ma will receive training in three areas: (1) behavioral sleep medicine and clinical trials; (2) qualitative and mixed methods research; and (3) mobile health (mHealth), technology-based sleep interventions and assessment. These training aims will be supported by strong institutional resources, as well as coursework, trainings, research seminars/meetings, and scientific conferences. MENTORSHIP. The candidate will be supported by an expert mentoring team including primary mentors Janet Mullington, PhD and Gloria Yeh, MD, MPH, co-mentor/collaborators Peter Wayne, PhD, Suzanne Bertisch, MD, MPH, Ana-Maria Vranceanu, PhD, John Torous, MD, MBI, Pamela Rist, ScD, and Karen Kilgore, PhD. IMPACT. Findings from the pilot study will inform the design of a larger trial and form the necessary foundation to further investigate mobile-health MM approaches for insomnia disorder and understand links between pre-sleep MM and sleep quality. Building on the candidate’s existing skills in physiological signal analysis, this K23 award will allow the candidate’s development as a clinical/translational researcher with expertise in mobile technology-based MM intervention and assessment for management of sleep, and complex physiological signals to elucidate the effects of MM on sleep.