An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder

March 12, 2026 updated by: Duke University
Posttraumatic stress disorder (PTSD) is a chronic, debilitating psychiatric disorder that is associated with an increased risk of death due to cardiovascular disease (CVD). Most individuals with PTSD also have Insomnia Disorder. Sleep quality is also associated with risk factors for CVD. The objective of this study is to examine how insomnia contributes to CVD risk among people with PTSD. The investigators will also examine whether this risk can be decreased with treatment for Insomnia Disorder.

Study Overview

Status

Status

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

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.

Detailed Description

Posttraumatic stress disorder (PTSD) is a disabling and costly psychiatric disorder that is estimated to occur in 20% of individuals who are exposed to a traumatic event and is chronic in one third of cases. In addition to its negative impact on quality of life, there is substantial evidence that PTSD (even after controlling for depression and other risk factors) is associated with a markedly increased risk of cardiovascular morbidity and mortality. However, the mechanisms for the association between PTSD and cardiovascular disease (CVD) risk are not well understood. Although adverse health behaviors, including cigarette smoking, alcohol abuse and poor medication adherence are common in PTSD, recent prospective studies show that they do not account for the magnitude of CVD risk among individuals with PTSD. The investigators propose to test our central hypothesis by evaluating whether CBT-I results in improved biomarkers of CVD risk among those with PTSD. Well established biomarkers of CVD related morbidity and mortality will be used including measures of vascular endothelial function measured by brachial artery flow-mediated dilation (FMD), nighttime blood pressure (BP) dipping measured using 24-hour ambulatory blood pressure monitoring (ABPM), and sympathetic nervous system (SNS) activity as measured by 24-hour urinary catecholamines. Investigators will also assess lipid profile, which along with BP is a modifiable component with marked impact on the atherosclerotic cardiovascular disease (ASCVD) risk score. The primary sleep parameter of interest is objectively-measured sleep efficiency (through actigraphy), although self-report insomnia measures and sleep related arousal will also be measured. The rationale for the proposed research is that once it is established that insomnia is an important and modifiable symptom conveying increased CVD risk in this population, the development of new and innovative approaches to integrating insomnia treatment with PTSD-focused interventions can be developed. 150 men and women with comorbid PTSD and insomnia disorder will be randomly assigned with a 2:1 ratio to 8-week cognitive behavioral therapy-Insomnia (CBT-I) intervention or a waiting period control condition. Sleep quality parameters and CVD risk biomarkers will be assessed at pre-randomization baseline, post-intervention, and at a 6-month follow-up. The study is designed to evaluate the association between insomnia and CVD risk biomarkers among persons with PTSD, and determine whether improvements in insomnia symptoms are associated with improvements in CVD risk biomarkers.

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 (Actual)

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.
140

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.
  • Not Applicable

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 Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27706
        • Duke University Medical Center

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

40 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is between 40-59 years old;
  • Has a current diagnosis of chronic PTSD (at least 3 months duration) based on the Clinician Administered PTSD Scale DSM-5 version (Weathers et al., 2013);
  • Has a current diagnosis of ID as defined in the International Classification of Sleep Disorders (ICSD-3; American Academy of Sleep Medicine, 2014)

Exclusion Criteria:

  • Has a history of CVD events, including myocardial infarction, stroke, transient ischemic attack, or coronary revascularization;
  • Has diagnosis of congestive heart failure or coronary artery disease based on results of diagnostic testing;
  • Has a current alcohol use or substance use disorder (those who meet lifetime but not current alcohol or substance use disorder will be included);
  • Is currently participating in or has recently (past 6 months) participated in an evidence-based trauma focused therapy for PTSD;
  • Has cognitive impairment as evidenced by less than 20 on the Montreal Cognitive Assessment scale (M0CA; Nasreddine et al., 2005);
  • Meets criteria for a psychotic spectrum disorder or bipolar disorder;
  • Has severely impaired hearing or speech;
  • Is pregnant;
  • Does not use benzodiazepines for sleep, and if prescribed benzodiazepines for some other use (e.g., anxiety, panic attacks), uses them fewer than four times in a one month period.;
  • Is not stable (medications and dose stable for one month) on any other current psychoactive and/or cardiovascular medications or will not be stable on these medications during the course of the study;
  • Works night shift;
  • Is participating in another interventional study to address insomnia;
  • Has prominent suicidal or homicidal ideation (as assessed through a clinical interview);
  • Has a serious/terminal illness or other health problem that would prohibit participation in the study;
  • Has nonclinically significant or sub-threshold insomnia as indicated by a score of <8 on the Insomnia Severity Index;
  • Has seizures (based on clinical interview and self-report);
  • Has a body mass index of 45 or greater;
  • Has sleep apnea (based on the overnight assessment described below) or a positive sleep apnea screen;
  • Has restless leg syndrome (based on the Duke Structured Interview for Sleep Disorders (DSISD); Edinger, Wyatt, & Olsen, 2009), and that sleep disorder is the primary cause of their sleep complaint (participants with restless legs syndrome who also have insomnia disorder can be included in the study);
  • Has an organic cause of sleep disruption that cannot be addressed by cognitive-behavioral changes (e.g., hyperthyroidism), as determined by the DSISD;
  • Has excessive daytime sleepiness, defined as a score >15 on the Epworth Sleepiness Scale (ESS) or as determined by the DSISD;
  • Does not complete sleep diary assessments within 6 hours of rising on at least 5 of the 7 days of the initial assessment period; or
  • Cancels or no-shows for two or more Time 1 assessment appointments
  • Has uncontrolled hypertension (screening office BP > 160/100 mm Hg)

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: Cognitive Behavior Therapy for Insomnia (CBT-I)
Participants assigned to this arm will receive eight sessions of a well-established, evidence-based therapy called cognitive behavior therapy for insomnia (CBT-I).
Behavioral: Cognitive Behavior Therapy for Insomnia
8 sessions of treatment for insomnia.
Other Names:
  • CBT-I
Other: Minimal Contact Control Condition
Participants assigned to this condition will be contacted every week for eight weeks and monitored regarding their insomnia symptoms.
Behavioral: Weekly phone contacts
Weekly calls to monitor insomnia symptoms.

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
Change in nighttime blood pressure
Time Frame: Baseline and post-treatment (approximately eight weeks)
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Baseline and post-treatment (approximately eight weeks)
Change in nighttime blood pressure
Time Frame: Baseline and 6-month follow-up
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Baseline and 6-month follow-up
Change in nighttime blood pressure dipping
Time Frame: Baseline and post-treatment (approximately eight weeks)
Systolic and diastolic blood pressure dipping measured by 24-hour ambulatory blood pressure monitoring, and defined as the percent change in blood pressure from the wake period to the nighttime sleep period.
Baseline and post-treatment (approximately eight weeks)
Change in nighttime blood pressure dipping
Time Frame: Baseline and 6-month follow-up
Systolic and diastolic blood pressure dipping measured by 24-hour ambulatory blood pressure monitoring, and defined as the percent change in blood pressure from the wake period to the nighttime sleep period.
Baseline and 6-month follow-up
Change in vascular endothelial function
Time Frame: Baseline and post-treatment (approximately eight weeks)
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery. V
Baseline and post-treatment (approximately eight weeks)
Change in vascular endothelial function
Time Frame: Baseline and 6-month follow-up
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery.
Baseline and 6-month follow-up
Change in nighttime sympathetic nervous system activity
Time Frame: Baseline and post-treatment (approximately eight weeks)
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Baseline and post-treatment (approximately eight weeks)
Change in nighttime sympathetic nervous system activity
Time Frame: Baseline and 6-month follow-up
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Baseline and 6-month follow-up
Change in 10-year atherosclerotic cardiovascular disease risk
Time Frame: Baseline and post-treatment (approximately eight weeks)
The risk of having a primary atherosclerotic cardiovascular disease event within 10 years will be based upon the pooled cohort equations model developed by the American College of Cardiology/American Heart Association.
Baseline and post-treatment (approximately eight weeks)
Change in 10-year atherosclerotic cardiovascular disease risk
Time Frame: Baseline and 6-month follow-up
The risk of having a primary atherosclerotic cardiovascular disease event within 10 years will be based upon the pooled cohort equations model developed by the American College of Cardiology/American Heart Association.
Baseline and 6-month follow-up
Change in insomnia severity
Time Frame: Baseline and post-treatment (approximately eight weeks)
Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.
Baseline and post-treatment (approximately eight weeks)
Change in insomnia severity
Time Frame: Baseline and 6-month follow-up
Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.
Baseline and 6-month follow-up
Change in sleep efficiency
Time Frame: Baseline and post-treatment (approximately eight weeks)
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
Baseline and post-treatment (approximately eight weeks)
Change in sleep efficiency
Time Frame: Baseline and 6-month follow-up
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
Baseline and 6-month follow-up

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
Change in subjective sleep quality
Time Frame: Baseline and 6-month follow-up
Sleep quality will be measured by the Pittsburgh Sleep Quality Index. The scale has a score range of 0 to 21, with lower scores on this measure indicating better sleep quality.
Baseline and 6-month follow-up
Change in subjective sleep quality
Time Frame: Baseline and post-treatment (approximately eight weeks)
Sleep quality will be measured by the Pittsburgh Sleep Quality Index.scale has a score range of 0 to 21, with lower scores on this measure indicating better sleep quality.
Baseline and post-treatment (approximately eight weeks)
Change in quality of life
Time Frame: Baseline and 6-month follow-up
Quality of life will be measured using the Short Form-36 Health Survey. Scores on this measure range from 0 to 100, with higher scores indicating better quality of life.
Baseline and 6-month follow-up
Change in quality of life
Time Frame: Baseline and post-treatment (approximately eight weeks)
Quality of life will be measured using the Short Form-36 Health Survey. Scores on this measure range from 0 to 100, with higher scores indicating better quality of life.
Baseline and post-treatment (approximately eight 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.
Duke University

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: Jean C Beckham, PhD, Duke Health
  • Principal Investigator: Andrew Sherwood, PhD, Duke Health

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 15, 2021

Primary Completion (Actual)

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.
March 9, 2026

Study Completion (Actual)

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.
March 9, 2026

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).
July 30, 2020

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.
August 3, 2020

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.
August 4, 2020

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.
March 16, 2026

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.
March 12, 2026

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.
March 1, 2026

More Information

Terms related to this study

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.
  • PRO00100446

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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