Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
2 other identifiers
interventional
600
2 countries
4
Brief Summary
Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2024
Longer than P75 for early_phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
November 10, 2025
November 1, 2025
3.7 years
February 19, 2024
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
9 weeks
Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
9 weeks
Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
35 weeks
Secondary Outcomes (11)
Insomnia Severity Index (ISI) Score following CBT-I
9 weeks
Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
9 weeks
Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
9 weeks
Evening Cortisol levels following CBT-I
9 weeks
Insomnia Severity Index (ISI) Score following RCT
9 weeks
- +6 more secondary outcomes
Study Arms (2)
Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo
PLACEBO COMPARATORSubjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.
Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone
ACTIVE COMPARATORSubjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.
Interventions
Subjects will receive therapy for 8 weeks
Non-remitting subjects will receive Trazodone (dosage) for 8 weeks
Non-remitting subjects will receive placebo for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
National Jewish Health
Denver, Colorado, 80206-2761, United States
Penn State University
Hershey, Pennsylvania, 17033, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-3203, United States
Université Laval
Québec, Quebec, G1V 0A6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandros Vgontzas, MD
Professor, Psychiatry
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Both prescribing physicians and participants will be blind to phenotype and treatment groups.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Psychiatry
Study Record Dates
First Submitted
February 19, 2024
First Posted
February 28, 2024
Study Start
March 20, 2024
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
May 31, 2028
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Data collected for aim 1 (an observational study) and aim 2 (a randomized clinical trial) will be made available no more than 3 years after the completion of the last follow-up assessment. Data will be submitted to the Program Officer and uploaded to the NHLBI BioLINCC repository no later than 3 years after the end of clinical activity or 2 years after the main outcomes paper is published, whichever comes first.
- Access Criteria
- NHLBI BioLINCC repository
The investigators have extensive experience preparing data and documentation to be available for public. They agree to abide by the principles for sharing research resources described by the National Heart, Lung, Blood Institute (NHLBI). A copy of the data will be uploaded to the NHLBI Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) repository. The datasets will not include any personal identifiers related to participants or clinical sites. Dates will be de-identified through a date-shifting algorithm to mask actual dates while maintaining a relation to the epoch in which events occurred. Data tables will be exported in comma-separated format, readable by statistical software. Variable dictionaries and code books, detailing variable description, format, value domain and labels, will be produced. Raw data files for polysomnogram/actigraphy/cortisol will also be made available, ensuring that data are linkable to study data and data are de-identified.