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  • Comparative Effectiveness of Zolpidem...

Comparative Effectiveness of Zolpidem and Cognitive Behavioral Therapy for Insomnia in Rural Adults (COZi-R)

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Project Summary  

Insomnia is a common health problem that causes distress, impaired function, and increased risk for other health problems. Chronic insomnia is defined by problems with the quality or amount of sleep, including difficulty falling asleep, frequent awakenings, and/or awakening early and being unable to return to sleep.

In developing this application, patients, providers, payors, and the investigators identified concerns and opportunities with current treatments for chronic insomnia. Medications and Cognitive-Behavioral therapy for insomnia (CBT-I); a treatment program to improve sleep through changes in behavior and thinking) are both effective for treating insomnia. Zolpidem, the most frequently prescribed insomnia medication, is widely available, but may cause side effects and dependency. CBT-I is the recommended first-line treatment by many professional organizations, but it is not widely available in physicians’ practices.

Patients, providers, and payors face important unanswered questions. Which treatment should be used for the treatment of chronic insomnia? Is combination therapy more effective, and does it result in lower zolpidem use? Who responds best to which treatment? These dilemmas are particularly relevant to patients and providers in rural areas, where access to behavioral health specialists is limited, and concerns regarding use of controlled substances is particularly acute. To address these questions, we will use a well-tested Internet version of CBT-I, which is just as effective as in-person CBT-I, but more widely available. The aims of COZI-R are to compare the effectiveness of zolpidem, CBT-I, and combination treatment for insomnia symptoms over 12 months; to compare the effectiveness of zolpidem, CBT-I, and combination treatment for other symptoms and problems, including health-related quality of life, mood, and health outcomes; to compare the side effects of zolpidem, CBT-I, and combination treatment; and to examine who responds best to which treatment.

We will study 1,200 patients (400 per treatment) recruited from 8 healthcare systems across the country, each of which has established practices in rural areas. Patients will be treated with medication prescribed by their own physician, Internet CBT-I, or a combination of the two. We will evaluate treatment effects at 9 weeks, and 6 and 12 months.

Our study questions and design reflect early and ongoing engagement of key stakeholders including patients, providers, and payors, who are members of the Study Advisory Committee (SAC). SAC members will work with study investigators to recommend the best strategies for recruiting patients, measuring treatment effects, and disseminating study findings. The SAC will meet quarterly. Patients and other stakeholders have already provided guidance on which treatments are most worth studying, and which symptoms would best reflect the effects of treatment. Patients and other stakeholders will also be part of the Steering Committee, which is the main decision-making group for our study, and which will meet monthly. This project could lead to answers for patients and providers addressing insomnia; improved health and function for millions of rural Americans; and sustainable changes in how insomnia is treated in rural practices.

Project Details

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.

Page Last Updated: 
September 28, 2020

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February 2
PCORI 2021 and Beyond: Opportunities for Funding and Involvement in Patient-Centered Research
February 9
Board of Governors Meeting: February 9, 2021
February 11
Advisory Panel on Patient Engagement Winter 2021 Meeting

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