Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
NCT ID: NCT06281756
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
600 participants
INTERVENTIONAL
2024-03-20
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo
Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.
Cognitive Behavioral Treatment for Insomnia (CBT-I)
Subjects will receive therapy for 8 weeks
Placebo
Non-remitting subjects will receive placebo for 8 weeks
Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone
Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.
Cognitive Behavioral Treatment for Insomnia (CBT-I)
Subjects will receive therapy for 8 weeks
Trazodone
Non-remitting subjects will receive Trazodone (dosage) for 8 weeks
Interventions
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Cognitive Behavioral Treatment for Insomnia (CBT-I)
Subjects will receive therapy for 8 weeks
Trazodone
Non-remitting subjects will receive Trazodone (dosage) for 8 weeks
Placebo
Non-remitting subjects will receive placebo for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Alexandros Vgontzas
Professor, Department of Psychiatry
Principal Investigators
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Alexandros Vgontzas, MD
Role: PRINCIPAL_INVESTIGATOR
Professor, Psychiatry
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Roxane Horberg
Role: primary
Rachel Johnson
Role: backup
Carrie Criley
Role: primary
Laurie Brar
Role: primary
Manon Lamy
Role: primary
Other Identifiers
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STUDY00022285
Identifier Type: -
Identifier Source: org_study_id