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Cognitive Behavioral Therapy and Trazodone for Insomnia and Blood Pressure

This study is looking at how well two common insomnia treatments work for people with chronic insomnia, especially those who also have high blood pressure. The treatments are Cognitive Behavioral Therapy for Insomnia (CBT-I), which is a type of talk therapy, and trazodone, a non-habit-forming medication. Researchers want to see if people with different types of insomnia respond better to one treatment over the other. You might be able to join if you are 18 or older, can communicate in English, have chronic insomnia, and a BMI of 18.5 or higher. The study will measure if your insomnia symptoms improve after 9 weeks of treatment and again after 6 months. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 600 participants. It will compare Cognitive Behavioral Therapy for Insomnia (CBT-I) to trazodone or a placebo.
What's involved
Participants will receive 8 weeks of therapy for CBT-I, or 8 weeks of trazodone or placebo if they don't improve with CBT-I.
Compensation
Not stated in the trial record.
Follow-up
Your insomnia symptoms will be checked at 9 weeks and again at 35 weeks (6 months after treatment ends).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06281756

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Milton S. Hershey Medical Center
~600 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Cognitive Behavioral Treatment for Insomnia (CBT-I)TrazodonePlacebo

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Measured over 9 weeks
+2 more outcomes measured

Conditions

Insomnia
Insomnia Chronic
Insomnia, Primary
Blood Pressure
Blood Pressure, High

Explore related trials

Insomnia

Where it's being run

4 sites across 3 states
Pennsylvania2
Colorado1
Quebec1

Study leadership

  • Alexandros Vgontzas, MD · PRINCIPAL_INVESTIGATOR · Professor, Psychiatry

Who to contact

Carrie Criley
[email protected]
717-531-4123
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Age 18 or older
Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
Meets criteria for chronic insomnia
Body Mass Index (BMI) 18.5 kg/m2 and higher

Exclusion

Age \< 18
Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
Unwilling to share email address/cell phone number to accept survey links.
Life time diagnosis of psychotic or bipolar disorder
History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.
Started new or changed treatment for sleep apnea in the past three months
Does not meet criteria for chronic insomnia
Meets criteria for narcolepsy or hypersomnia disorder
Meets criteria for circadian rhythm disorder (including night shift work)
Unstable medical conditions that would make participation unsafe or unfeasible
Falls resulting in hospitalization, significant injury or fracture within past 12 months
2 hospitalizations or emergency room visits within past 12 months for chronic conditions
Active chemotherapy or radiation therapy for cancer
Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
Does not agree to refrain from other treatments for insomnia beyond what is offered in this study
BMI less than 18.5
Substance abuse or dependence in the past 12 months
Current use of prescription or over the counter medications taken for sleep greater than 2 times per week
Current use of systemic corticosteroids or opiate medications
Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study
Current use of medications contraindicated with trazodone
Sleep apnea or periodic leg movement disorder as determined by sleep study
Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
EKG corrected QT interval greater than or equal to 500 ms

What this trial measures

  • Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)9 weeks

    Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe

  • Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)9 weeks

    Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe

  • Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment35 weeks

    Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe