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

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.

NCT Number	NCT06281756
Lead Sponsor	Milton S. Hershey Medical Center Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Insomnia, Insomnia Chronic, Insomnia, Primary, Blood Pressure, Blood Pressure, High
Enrollment	600 participants
Start Date	2024-03-20
Primary Completion	2027-11-30 (estimated)
Study Completion	2028-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-10