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ID06281756

Effects of Cognitive Behavioral Therapy and Trazodone on Sleep Quality and Blood Pressure in Adults with Chronic Insomnia

Led by Milton S. Hershey Medical Center · Updated on 2025-11-10

600

Participants Needed

4

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying individuals with insomnia who have different patterns of sleep duration to understand how they respond to two common treatments. The study focuses on people with insomnia and short sleep duration compared to those with normal sleep duration. The goal is to determine if these groups respond differently to therapies to help guide better treatment choices and reduce health risks like high blood pressure. Participants first receive Cognitive Behavioral Therapy for Insomnia CBT-I for 8 weeks. Those who do not fully respond to this therapy then receive either a low dose of the medication trazodone or a placebo for another 8 weeks. The study includes a randomized controlled trial phase with triple masking to compare these treatment approaches. During the study, participants will be assessed for remission of insomnia symptoms at 9 weeks after each treatment phase and again 6 months later. Researchers will measure sleep quality using tools like polysomnography and actigraphy, evaluate blood pressure, and monitor cortisol levels. The total involvement includes therapy sessions, medication or placebo treatment, and follow-up assessments over several months to track treatment effects and safety.

CONDITIONS

Brief Title

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Research Team

C

Carrie Criley

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