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

November 6, 2025 updated by: Alexandros Vgontzas, Milton S. Hershey Medical Center

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 0A6
  • United States
    • Colorado
      • Denver, Colorado, United States, 80206-2761
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Pittsburgh, Pennsylvania, United States, 15213-3203
        • Recruiting
        • University of Pittsburgh
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 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.
Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I)
Subjects will receive therapy for 8 weeks
Other: Placebo
Non-remitting subjects will receive placebo for 8 weeks
Active Comparator: 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.
Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I)
Subjects will receive therapy for 8 weeks
Drug: Trazodone
Non-remitting subjects will receive Trazodone (dosage) for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Time Frame: 9 weeks
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)
Time Frame: 9 weeks
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
Time Frame: 35 weeks
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
35 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI) Score following CBT-I
Time Frame: 9 weeks
0-28, with 0 being mild and 28 being severe
9 weeks
Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Time Frame: 9 weeks
Polysomnography (PSG) Sleep efficiency measured as a percentage of time asleep during sleep study
9 weeks
Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Time Frame: 9 weeks
Actigraphy Sleep efficiency measured as estimated sleep time at home (2 week period)
9 weeks
Evening Cortisol levels following CBT-I
Time Frame: 9 weeks
Cortisol levels measured in saliva collected following CBT-I
9 weeks
Insomnia Severity Index (ISI) Score following RCT
Time Frame: 9 weeks
0-28, with 0 being mild and 28 being severe
9 weeks
PSG Total Sleep Time (TST) following RCT
Time Frame: 9 weeks
PSG Total Sleep Time measured in minutes asleep during sleep study following RCT
9 weeks
Actigraphy Total Sleep Time (TST) following RCT
Time Frame: 9 weeks
Actigraphy Total Sleep Time measured in minutes asleep during home study following RCT
9 weeks
Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP)
Time Frame: 9 weeks
Morning SBP Blood Pressure Readings measured at home (7 day period)
9 weeks
Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP)
Time Frame: 9 weeks
Morning DBP Blood Pressure Readings measured at home (7 day period)
9 weeks
Evening Cortisol levels following RCT
Time Frame: 9 weeks
Cortisol levels measured in saliva collected following RCT
9 weeks
Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment
Time Frame: 35 weeks
Cortisol levels measured in saliva 6 months following CBT-I Or RCT Treatment
35 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandros Vgontzas, MD, Professor, Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00022285
  • 1UG3HL161342-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

NHLBI BioLINCC repository

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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