CBT-I or Zolpidem/Trazodone for Insomnia

Completed · Phase 4

Conditions studied: Chronic Insomnia

In brief

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.

Key facts

Study ID

NCT04468776

Run by

California Pacific Medical Center Research Institute

People needed

155

Starts

2022-02-25

Expected to finish

2024-06-30

Last updated by the study team

2025-02-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• University of Missouri — Columbia, Missouri, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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