CBT-I or Sleep Medication for Chronic Insomnia

(COZI Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen by Daniel J. Buysse, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: California Pacific Medical Center Research Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is a randomized (1:1:1) comparative effectiveness trial of medication (zolpidem or trazodone), cognitive-behavioral therapy for insomnia (CBT-I), and the combination (medication + CBT-I) 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 155 participants will be enrolled and randomized in the United States. This trial is funded by the Patient-Centered Outcomes Research Institute.

Research Team

Katie L. Stone, PhD

Principal Investigator

California Pacific Medical Center/Sutter Bay Hospitals

Daniel J. Buysse, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for men and women aged 18-80 living in rural areas with chronic insomnia, who have regular internet access and a high Insomnia Severity Index score. It's not for those using sleep meds often, undergoing current insomnia therapy, or with severe mental/physical disorders including psychotic/bipolar disorders, substance use disorder, severe lung diseases, cognitive impairments, complex sleep behaviors or shift work at night.

Inclusion Criteria

Regular internet and computer access

Receives primary care in a Non-metropolitan/Rural residence

I am between 18 and 80 years old.

Exclusion Criteria

You are currently struggling with substance addiction.

I have had a fracture or a serious fall in the last year.

You have serious mental or physical problems that would make it hard or unsafe for you to take part in the study.

Treatment Details

Interventions

• Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) (Other)
• Trazodone (Other)
• Zolpidem (Other)

Trial Overview The study compares three approaches: Internet-based Cognitive Behavioral Therapy (CBT-I), medications Zolpidem or Trazodone alone, and their combination to treat chronic insomnia. Participants will be randomly assigned to one of these treatments and followed up for a year to see which is most effective.

Participant Groups

Group I: Combination Experimental Treatment 3 Interventions

Medication (zolpidem or trazodone) as prescribed by physician and Internet-based CBT-I program

Group II: Medication (zolpidem or trazodone) Active Control 2 Interventions

Zolpidem or trazodone, as prescribed by physician

Group III: Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) Active Control 1 Intervention

Internet-based CBT-I program

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pittsburgh Pittsburgh, PA

University of Missouri Columbia, MO

University of Virginia Charlottesville, VA

Penn State Hershey Medical Center Hershey, PA

More Trial Locations

Who Is Running the Clinical Trial?

California Pacific Medical Center Research Institute

Lead Sponsor

Trials

44

Patients Recruited

10,600+

University of Arizona

Collaborator

Trials

545

Patients Recruited

161,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Patients Recruited

27,110,000+

University of Pittsburgh

Collaborator

Trials

1820

Patients Recruited

16,360,000+

University of Virginia

Collaborator

Trials

802

Patients Recruited

1,342,000+

University of Illinois at Chicago

Collaborator

Trials

653

Patients Recruited

1,574,000+