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

Completed · Not applicable

Conditions studied: Insomnia, Posttraumatic Stress Disorder, Cardiovascular Risk Factor

In brief

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.

Key facts

Study ID

NCT04498754

Run by

Duke University

People needed

140

Starts

2021-03-15

Expected to finish

2026-03-09

Last updated by the study team

2026-03-16

Who can join

Age: 40 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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