Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
EARLY_PHASE1
600
about 4.2 years
18+
3 sites in CO, PA
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Participate in Cognitive Behavioral Treatment for Insomnia (CBT-I)
- 2.Placebo
- 3.Take Trazodone
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
trazodone
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