# Interactive Cognitive Behavioral Therapy for Insomnia

> **NIH NIH R44** · MEDIA REZ, LLC · 2021 · $653,685

## Abstract

ABSTRACT
This study aims to further develop and test our voice-activated technology to deliver components of cognitive
behavioral therapy for insomnia (CBT-I) to breast cancer survivors (BCS). CBT-I is a structured, systematic
program which delivers better and safer outcomes than prescription sleep medications. Non-pharmacologic
approaches target physiologic, cognitive, behavioral, environmental, and social factors to improve sleep.
Insomnia has numerous health consequences, particularly for this high-risk population, and too few trained
CBT-I therapists are available to offer treatment. Online programs suffer from high dropout rates and are not
appropriate to use ”just-in-time” before sleep (i.e. in the bedroom) due to stimulating screen exposures.
Participants will interact with an internet-connected speaker to report sleep patterns and receive feedback,
more closely mimicking the experience of an in-person provider than web-based programs. In Aim 1, our
multidisciplinary team will invite n=16-20 BCS with insomnia to use the “Sleep Helper” prototype, collecting
data both through participant observation and through week long at home rapid testing. We will use results to
iteratively improve the program. We will refine and debug the prototype before conducting our Aim 2, week
long at home pilot testing among n=20 BCS to compare sleep data collected by the program with validated
self-report and objective measures, and to measure participant engagement and usability of the program. In
our final aim we will test the program for efficacy using a randomized controlled trial design with n=58 BCS. We
will measure differences between intervention and usual care from baseline to post six-week intervention. Our
central hypothesis is that the intervention group will have significantly greater reductions in clinically significant
insomnia as recorded by the Insomnia Severity Index. Secondarily, we will measure participant engagement
with the program and user satisfaction. This intervention includes engaging and educational elements, and
multiple areas of innovation which overcome current impediments to the delivery of scalable, automated CBT-I.
We anticipate that the results will demonstrate efficacy of the CBT-I system on insomnia through a randomized
controlled trial as well as more feedback on usability and acceptability of the system. Successful completion of
Phase II aims will provide evidence to support our commercialization plan to provide this technology to the
growing population of BCS with insomnia who lack access to trained CBT-I therapists, as well as to tailor it to
other high-risk populations. We also plan to test it as part of a stepped-care model with in-person therapists.

## Key facts

- **NIH application ID:** 10149255
- **Project number:** 5R44CA232905-03
- **Recipient organization:** MEDIA REZ, LLC
- **Principal Investigator:** Hannah Arem
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $653,685
- **Award type:** 5
- **Project period:** 2018-07-03 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10149255

## Citation

> US National Institutes of Health, RePORTER application 10149255, Interactive Cognitive Behavioral Therapy for Insomnia (5R44CA232905-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10149255. Licensed CC0.

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