PROJECT SUMMARY/ABSTRACT
Treatment-seeking insomnia sufferers most often present in primary care where their first and usually only
treatment is a prescription hypnotic medication. More than 65% of individuals prescribed hypnotics use them for
more than a year, and more than 30% remain on them for more than five years. Such agents may be useful for
acute insomnia and certain cases with chronic sleep difficulties, but prolonged hypnotic use can lead to
dependency and increased morbidity (e.g., falls, cognitive/driving impairments). Reducing or discontinuing
hypnotics after prolonged use is a challenging task for both prescribing physicians and the patients who use
them. Although evidenced-based physician-supervised medication tapering (SMT) protocols have shown
efficacy, such interventions have yet to be disseminated widely in primary care. Most primary care providers
(PCPs) are willing to refer their insomnia patients to alternative evidence-based non-drug treatments such as
cognitive behavioral insomnia therapy (CBTI), but such treatment is often difficult to access outside of specialty
sleep centers. Given this gap between research and clinical practice, there is a pressing need to develop and
validate cost-effective interventions to facilitate the management of insomnia and hypnotic tapering in primary
care. In response to PAR-20-183, This application has been carefully designed to address these issues. We
will conduct a large randomized trial to compare the combined digital CBT (dCBTI)/SMT intervention, to the
SMT intervention delivered alone for producing hypnotic discontinuation and insomnia symptom improvement.
A sample of 430 hypnotic-reliant patients drawn from 8-10 primary care clinics within a practice-based research
network affiliated with the University of Colorado Medical School in Aurora, Colorado will serve as study
participants. The main objective of the project is to compare the performance of dCBTI+SMT with SMT used
alone for achieving hypnotic reduction/discontinuation and insomnia symptom improvement. In addition, we
will incorporate an Effectiveness-Implementation assessment into the RCT to identify patient- provider- and
system-level factors that may impact adoption, implementation and maintenance of the types of interventions
tested. Findings from the effectiveness/implementation should help design future trials of implementation
strategies identified herein to promote dissemination of dCBTI and SMT interventions into primary care should
these treatments prove effective in the current trial. We also will gather exploratory data to determine who
responds best to dCBTI/SMT. This study will provide new and useful information about the feasibility, clinical
utility, and patient-, provider-, and system-level acceptability of these interventions to manage insomnia and
reduce/eliminate hypnotic use in primary care. This project should serve as a necessary first step toward the
eventual dissemination of accessible, cost-effective strategies to manage a significant public health problem and
improve the quality of life of millions of chronic users of controlled-substance sleep aids.
