CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 155 enrolled
Drug / intervention
Zolpidem +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04468776
NCT04468776Phase 4Completed
CompareCT.gov

Comparative Effectiveness of Zolpidem/Trazodone and Cognitive Behavioral Therapy for Insomnia in Rural Adults

California Pacific Medical Center Research Institute·interventional·Posted Jul 13, 2020·Updated Feb 24, 2025

In Brief

A Phase 4 clinical trial evaluating Zolpidem, Internet Cognitive Behavioral Therapy for Insomnia (CBT-I), and 1 other intervention for Chronic Insomnia. Completed, enrolled 155 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Insomnia
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute, University of Pittsburgh, University of Arizona, University of Virginia, University of Illinois at Chicago

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJul 13, 2020
Enrollment StartFeb 25, 2022
Primary CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.0 years ago

Interventions

Zolpidemdrug

Zolpidem, as prescribed by physician

Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)behavioral

6-week internet CBT-I multi-component intervention (SHUTi) including sleep restriction, stimulus control, cognitive restructuring, sleep behaviors, and relapse prevention

Trazodonedrug

Trazodone, as prescribed by physician