Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Fresno, California and other locations
Dates
study started
estimated completion
Principal Investigator
Andrew Krystal, MD

Description

Summary

This study is a randomized (1:1:1) comparative effectiveness trial of Zolpidem, cognitive-behavioral therapy for insomnia (CBT-I), and the combination for the treatment of chronic insomnia in men and women aged 18-80 living in rural areas with 1 year of follow-up. A total of 1200 participants will be enrolled and randomized in the United States. This trial is funded by the Patient-Centered Outcomes Research Institute.

Official Title

Comparative Effectiveness of Zolpidem and Cognitive Behavioral Therapy for Insomnia in Rural Adults

Details

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 both 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, propose the study, Comparative Effectiveness of Zolpidem and Cognitive Behavioral Therapy for Insomnia in Rural Adults (COZI). The investigators 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 are to: 1: Compare the effectiveness of zolpidem, CBT-I, and combination treatment for insomnia symptoms over 12 months. 2: 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. 3: Compare the side effects of zolpidem, CBT-I, and combination treatment. 4: Examine who responds best to which treatment. COZI will study 1200 patients (400 per treatment) recruited from 8 health care 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. The investigators 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. COZI will 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.

Keywords

Chronic Insomnia Insomnia Zolpidem Ambien Cognitive-behavioral therapy for insomnia CBT-I Rural Primary Care Pragmatic Clinical Trial Comparative Effectiveness Sleep Initiation and Maintenance Disorders Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)

Eligibility

You can join if…

Open to people ages 18-80

  • Age 18-80
  • Insomnia Severity Index score > 10
  • Regular internet and computer access
  • Receives primary care in a Non-metropolitan/Rural area

You CAN'T join if...

  • Current regular (>3x/week) use of hypnotic medication
  • Psychotic disorder
  • Bipolar disorder
  • Current substance use disorder
  • Severe Chronic obstructive pulmonary disease (COPD) or other severe pulmonary disease (such as asthma or lung fibrosis)
  • Cognitive impairment
  • History of spontaneous or hypnotic-induced complex sleep behavior
  • History of fracture or injurious fall in the past 12 months

Locations

  • University of California, San Francisco-Fresno
    Fresno California 93701 United States
  • Oregon Health & Science University
    Portland Oregon 97239 United States

Lead Scientist at UCSF

  • Andrew Krystal, MD
    Professor, Psychiatry. Authored (or co-authored) 203 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
California Pacific Medical Center Research Institute
ID
NCT04468776
Phase
Phase 4
Study Type
Interventional
Last Updated