RecruitingEarly Phase 1NCT06281756

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


Sponsor

Milton S. Hershey Medical Center

Enrollment

600 participants

Start Date

Mar 20, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatments for chronic insomnia — cognitive behavioral therapy for insomnia (CBT-I, a talking therapy that helps change thoughts and habits around sleep) and trazodone (a medication) — to see which is more effective for sleep and also for blood pressure. Many people with insomnia also have elevated blood pressure. **You may be eligible if...** - You are 18 years or older - You meet diagnostic criteria for chronic insomnia - You can read and communicate effectively in English (or French at the Canadian site) - Your BMI is 18.5 kg/m² or higher **You may NOT be eligible if...** - You have a lifetime diagnosis of psychotic disorder or bipolar disorder - You have severe untreated sleep apnea (a condition where breathing stops repeatedly during sleep) - You have narcolepsy, hypersomnia, or a circadian rhythm disorder (including night shift work) - You have unstable medical conditions making participation unsafe - You have had recent falls causing hospitalization or fractures - You are currently on chemotherapy or radiation therapy for cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive Behavioral Treatment for Insomnia (CBT-I)

Subjects will receive therapy for 8 weeks

DRUGTrazodone

Non-remitting subjects will receive Trazodone (dosage) for 8 weeks

OTHERPlacebo

Non-remitting subjects will receive placebo for 8 weeks


Locations(4)

National Jewish Health

Denver, Colorado, United States

Penn State University

Hershey, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Université Laval

Québec, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06281756


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