Phase 4
N=155
CBT-I or Zolpidem/Trazodone for Insomnia
Chronic Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT04468776 ↗Enrolled (actual)
155
Serious AEs
1.9%
Results posted
Feb 2025
Primary outcome: Primary: Change in Insomnia Symptom Severity — -8.05; -7.82; -10.19 change score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Zolpidem (Drug); Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral); Trazodone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- California Pacific Medical Center Research Institute
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insomnia Symptom Severity |
-8.05; -7.82; -10.19 | — |
| SECONDARY Number of Participants With Treatment Response of Insomnia Symptoms |
22; 21; 31 | — |
| SECONDARY Number of Participants With Remission of Insomnia Symptoms |
16; 13; 16 | — |
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 155 participants will be enrolled and randomized in the United States. This trial is funded by the Patient-Centered Outcomes Research Institute.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04468776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.