CBT-I or Zolpidem/Trazodone for Insomnia
Key facts
- Who runs it
- California Pacific Medical Center Research Institute
- Where
- Birmingham, Charlottesville, Columbia, Hershey, Pittsburgh, Portland, and Tucson, United StatesSee the 7 sites
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 155 people enrolled
- Started
- 25 Feb 2022
- Ended
- 30 Jun 2024
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Zolpidem
- Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Trazodone
- Record updated
- 24 February 2025
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Age 18-80
- Insomnia Severity Index score > 10
- Regular internet and computer access
- Receives primary care in a Non-metropolitan/Rural residence
Who cannot take part
- Use of hypnotic medication >2 times in the past week
- 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)
- History of fracture or injurious fall in the past 12 months
- Other severe or uncontrolled mental or physical disorders that would make participation difficult or unsafe
- Current cognitive or cognitive behavioral treatment for insomnia
- Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
- Currently pregnant, planning to become pregnant, or breastfeeding
Where in United States
- University of Alabama at BirminghamBirmingham, United States
- University of VirginiaCharlottesville, United States
- University of MissouriColumbia, United States
- Penn State Hershey Medical CenterHershey, United States
- University of PittsburghPittsburgh, United States
- Oregon Health Science UniversityPortland, United States
- University of ArizonaTucson, United States
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Medication (zolpidem or trazodone)Existing treatment, for comparison
Zolpidem or trazodone, as prescribed by physician
Treatment: Zolpidem and Trazodone
- Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)Existing treatment, for comparison
Internet-based CBT-I program
- CombinationTreatment being tested
Medication (zolpidem or trazodone) as prescribed by physician and Internet-based CBT-I program
Treatment: Zolpidem, Internet Cognitive Behavioral Therapy for Insomnia (CBT-I), and Trazodone
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparative Effectiveness of Zolpidem/Trazodone and Cognitive Behavioral Therapy for Insomnia in Rural Adults
- Record updated
- 24 February 2025