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.
