Study Information

Project Summary  

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

Principal Investigator

Katie Stone, PhD, MA

Project Status

In progress; Not yet recruiting

Board Approval Date

April 2019

Project End Date

May 2025

Organization

Sutter Bay Hospitals

Year Awarded

2019

State

California

Project Type

Research Project

Health Conditions

  • Mental/Behavioral Health
  • Multiple/Comorbid Chronic Conditions

Intervention Strategies

  • Behavioral Interventions
  • Drug Interventions
  • Other Clinical Interventions
  • Other Health Services Interventions
  • Technology Interventions
  • Training and Education Interventions

Populations

  • Individuals with Multiple Chronic/co-morbid Conditions
  • Racial/Ethnic Minorities
  • Rural
  • Women

Funding Announcement

Assessment of Prevention, Diagnosis, and Treatment Options

Project Budget * 

$5,464,174

Study Registration Information

NCT04468776

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.