Design and Recruitment for the Comparative Effectiveness of Zolpidem/Trazodone and Cognitive Behavioral Therapy for Insomnia (COZI) Study in Rural Adults

OBJECTIVES: Cognitive behavioral therapy for insomnia (CBT-I) is widely recommended, but access remains limited, particularly among rural adults. Medications to treat insomnia, including zolpidem and trazodone, are widely used but can have significant side effects. Empirical evidence remains sparse to support the choice of CBT-I, medication, or combined treatment in clinical practice. METHOD: This paper describes the Comparative Effectiveness of Zolpidem/Trazodone and Cognitive Behavioral Therapy for Insomnia (COZI) study, which aimed to compare the effectiveness of medications and behavioral interventions for chronic insomnia. RESULTS: COZI was a multi-center randomized trial in rural adults (aged 18-80) with chronic insomnia. The effects of three insomnia treatments were compared: digital CBT-I (dCBT-I), medication (patient/provider choice of zolpidem or trazodone), and the combination of medication plus dCBT-I. Treatment outcomes were measured at 9 weeks, 6 months, and 12 months. The primary outcome was change in severity of insomnia symptoms (ISI) over 6 months. Secondary outcomes included change in insomnia symptom severity at 9 weeks and 12 months, adverse events, and other patient-centered outcomes. CONCLUSIONS: Study results will provide support for clinical decision-making in insomnia treatment.