Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Insomnia is a sleep disorder that can make it hard to fall asleep or stay asleep. People can take medicines to treat insomnia, but they can cause dependence or side effects, such as daytime fatigue or memory problems. To avoid these problems, some people choose to treat insomnia with behavioral therapy. But people who live in rural areas may not have access to these services.

In this study, the research team is comparing three ways to treat insomnia among people living in rural areas:

  • Internet-based cognitive behavioral therapy for insomnia, or internet CBT-I. This approach helps people learn healthy sleep habits and change behaviors that make insomnia worse. Internet CBT-I also teaches people how to deal with thoughts that keep them awake.
  • Medicine for insomnia. People receiving medicine are prescribed zolpidem or trazodone based on their preference. Doctors guide decisions about the medicine, such as how much to take and when to stop taking it.
  • Internet CBT-I plus medicine.

Who can this research help?

Results may help doctors and patients when considering ways to treat insomnia.

What is the research team doing?

The research team is enrolling 1,200 people with insomnia from rural clinics across the United States. The team is assigning people by chance to receive internet CBT-I, medicine, or both. The internet CBT-I program lasts six weeks.

The research team is measuring people’s insomnia symptoms at the start of the study and again 9 weeks, 6 months, and 12 months later. After the program ends, the team is comparing symptoms of insomnia across the three groups. The team is also looking to see if the three groups differ in other sleep or health outcomes such as quality of life and mood. Finally, the team is looking to see if the treatments work differently based on factors such as age or gender.

People with insomnia, primary care doctors, and health insurers are helping to plan and conduct this study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 1,200 adults with insomnia who are living in rural areas
Interventions/
Comparators
  • Internet CBT-I
  • Medicine (zolpidem or trazodone)
  • Internet CBT-I plus medicine
Outcomes

Primary: change in insomnia symptoms

Secondary: treatment response (change in insomnia symptoms), remission in insomnia symptoms; sleep quality, sleepiness, quality of life, mood, pain, cognition, fatigue, medicine use and side effects (e.g., falls) 

Timeframe 1-year follow-up for primary outcome

Project Information

Katie Stone, PhD, MA
Sutter Bay Hospitals
$5,464,174
Comparative Effectiveness of Zolpidem and Cognitive Behavioral Therapy for Insomnia in Rural Adults (COZi-R)

Key Dates

April 2019
May 2025
2019

Study Registration Information

Tags

Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022