Development of an mHealth Behavioral Sleep Medicine Intervention for use during Medication Assisted Treatment for Opioid Use Disorder

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PROJECT SUMMARY/ABSTRACT The goal of the proposed Behavioral and Integrative Treatment Development Program (R34) is to develop and test a mobile health (mHealth) application of evidence-based behavioral treatment for sleep problems in persons beginning treatment for opioid use disorder (OUD) with medications for OUD (MOUD). OUD is a highly prevalent problem with major public health implications. MOUD is the first-line treatment for OUD, though sleep complaints in persons receiving MOUD are highly prevalent, persistent, and connected to negative treatment outcomes. Interventions for insomnia and other sleep problems in those receiving MOUD are lacking, as pharmacological options are limited and there are multiple barriers to receiving evidence-based non-pharmacological/cognitive behavioral treatment, including competing treatment demands, lack of trained providers, and time and effort involved in in-person sessions. Modifying evidence-based behavioral sleep interventions for delivery via a patient-focused mobile application with special consideration to factors specific to persons receiving MOUD would fill this treatment gap by circumventing many of these obstacles related to accessing in-person treatment. The proposed research will develop and test a behavioral sleep medicine- based mobile application that includes components of interventions for sleep problems that are highly prevalent in MOUD treatment, including insomnia, circadian rhythm disorders, nightmares, and pain-related sleep difficulty. The ultimate goal of this project is to prepare for a large scale randomized clinical trial. Specific aims include: 1) Develop a mHealth application, NightRighter, based on cognitive behavioral therapy for insomnia and augmented with other evidence-based sleep interventions that address common sleep-related problems in OUD/MOUD utilizing input from persons beginning MOUD (n=5), stabilized on MOUD (n=5) or providing treatment for those receiving MOUD (n=5); 2) Run usability tests of NightRighter through alpha and beta testing (n=15-20); 3) Conduct a pilot randomized clinical trial (RCT) of NightRighter compared to a sleep hygiene control group (n=40) in preparation for a larger RCT. This proposal leverages the skills and expertise of all team members, including measurement of sleep problems in OUD of Dr. Wilkerson, OUD clinical care and clinical research experience of Drs. Book and McCrae, implementation of digital health tools of Dr. Ruggiero, and qualitative data collection and analyses in substance use disorders of Dr. Moreland.