Status:
COMPLETED
CBT-I or Zolpidem/Trazodone for Insomnia
Lead Sponsor:
California Pacific Medical Center Research Institute
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
University of Pittsburgh
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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) fo...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- Age 18-80
- Insomnia Severity Index score \> 10
- Regular internet and computer access
- Receives primary care in a Non-metropolitan/Rural residence
Exclusion
- Use of hypnotic medication \>2 times in the past week
- Current cognitive or cognitive behavioral treatment for insomnia
- 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 or dementia
- History of spontaneous or hypnotic-induced complex sleep behavior
- Delayed sleep phase disorder (DSPD)
- Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
- History of fracture or injurious fall in the past 12 months
- Currently pregnant, planning to become pregnant, or breastfeeding
- Other severe or uncontrolled mental or physical disorders that would make participation difficult or unsafe
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04468776
Start Date
February 25 2022
End Date
June 30 2024
Last Update
February 24 2025
Active Locations (7)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Arizona
Tucson, Arizona, United States, 85721
3
University of Missouri
Columbia, Missouri, United States, 65212
4
Oregon Health & Science University
Portland, Oregon, United States, 97239