Actively Recruiting
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort and Randomized Controlled Trial
Led by Milton S. Hershey Medical Center · Updated on 2025-11-10
600
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Milton S. Hershey Medical Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying individuals with insomnia who have different patterns of sleep duration to understand how they respond to two common treatments. The study focuses on people with insomnia and short sleep duration compared to those with normal sleep duration. The goal is to determine if these groups respond differently to therapies to help guide better treatment choices and reduce health risks like high blood pressure. Participants first receive Cognitive Behavioral Therapy for Insomnia (CBT-I) for 8 weeks. Those who do not fully respond to this therapy then receive either a low dose of the medication trazodone or a placebo for another 8 weeks. The study includes a randomized controlled trial phase with triple masking to compare these treatment approaches. During the study, participants will be assessed for remission of insomnia symptoms at 9 weeks after each treatment phase and again 6 months later. Researchers will measure sleep quality using tools like polysomnography and actigraphy, evaluate blood pressure, and monitor cortisol levels. The total involvement includes therapy sessions, medication or placebo treatment, and follow-up assessments over several months to track treatment effects and safety.
CONDITIONS
Brief Title
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Able to read and communicate effectively in English (U.S. sites) or English or French (Canadian site)
- Meets criteria for chronic insomnia
- Body Mass Index (BMI) of 18.5 kg/m2 or higher
You will not qualify if you...
- Under age 18
- Unable to read and communicate effectively in English (U.S. sites) or English or French (Canadian site)
- Unwilling to share email or cell phone for surveys
- Lifetime diagnosis of psychotic or bipolar disorder
- Untreated severe sleep apnea or Apnea Hypopnea Index ≥15 without appropriate therapy
- New or changed sleep apnea treatment in past 3 months
- Does not meet criteria for chronic insomnia
- Diagnosed with narcolepsy or hypersomnia
- Diagnosed with circadian rhythm disorder or night shift work
- Unstable medical conditions making participation unsafe
- Recent falls causing hospitalization or serious injury within 12 months
- Two hospitalizations or ER visits for chronic conditions within 12 months
- Receiving active chemotherapy or radiation for cancer
- History of chronic renal failure, liver insufficiency, or heart failure
- Refusal to avoid other insomnia treatments during the study
- BMI less than 18.5
- Substance abuse or dependence in past 12 months
- Current use of sleep medications more than twice a week
- Current use of systemic corticosteroids or opiates
- Pregnant, breastfeeding, planning pregnancy, or unwilling to use birth control
- Use of medications that interact with trazodone
- Sleep apnea or periodic leg movement disorder diagnosed by sleep study
- Blood pressure over seated SBP 180 or DBP 110 mmHg
- EKG corrected QT interval ≥500 ms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive Cognitive Behavioral Therapy for Insomnia (CBT-I) for 8 weeks.
Weekly visits for 8 weeks
Duration - 8 weeks
Non-remitting participants receive either Trazodone or placebo for 8 weeks.
Weekly visits for 8 weeks
Duration - Approximately 26 weeks
Participants are monitored for remission of insomnia symptoms and related outcomes up to 6 months after treatment completion.
Periodic visits during follow-up
Trial Site Locations
Total: 4 locations
1
National Jewish Health
Denver, Colorado, United States, 80206-2761
Actively Recruiting
2
Penn State University
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-3203
Actively Recruiting
4
Université Laval
Québec, Quebec, Canada, G1V 0A6
Actively Recruiting
Research Team
C
Carrie Criley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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