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

Milton S. Hershey Medical Center
NCT IDNCT06281756ClinicalTrials.gov data as of Apr 2026
Phase

EARLY_PHASE1

Target enrollment

600

Study length

about 4.2 years

Ages

18+

Locations

3 sites in CO, PA

About this study

This trial is testing whether Cognitive Behavioral Therapy for Insomnia (CBT-I) and trazodone, a medication, affect sleep and blood pressure in people with insomnia. The goal is to see if different types of treatments work better for certain kinds of insomnia.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Participate in Cognitive Behavioral Treatment for Insomnia (CBT-I)
  • 2.Placebo
  • 3.Take Trazodone
PhaseEARLY_Phase 1
DrugTrazodone
Primary goalRemission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low13%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

trazodone

Endpoints

Primary: Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment, Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I), Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)

Secondary: Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP), Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP), Insomnia Severity Index (ISI) Score following CBT-I, Insomnia Severity Index (ISI) Score following RCT