CBT-I or Zolpidem/Trazodone for Insomnia

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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) 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Pacific Medical Center Research Institute
• Collaborators: Patient-Centered Outcomes Research Institute; University of Arizona; University of Illinois at Chicago; University of Pittsburgh; University of Virginia
• Treatments: Trazodone; Zolpidem

Criteria

Inclusion Criteria:

• Age 18-80

• Insomnia Severity Index score > 10

• Regular internet and computer access

• Receives primary care in a Non-metropolitan/Rural residence

Exclusion Criteria:

• 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