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.
*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.