Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial
Milton S. Hershey Medical Center
600 participants
Mar 20, 2024
INTERVENTIONAL
Conditions
Summary
Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Subjects will receive therapy for 8 weeks
Non-remitting subjects will receive Trazodone (dosage) for 8 weeks
Non-remitting subjects will receive placebo for 8 weeks
Locations(4)
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NCT06281756