Evaluating insomnia treatment to lower heart disease risk in PTSD patients

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

This study is testing if treating insomnia with therapy can help reduce heart disease risk in people with PTSD.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 40 Years to 59 Years
• Sex: All
• Sponsor: Duke University (Academic / other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT04498754 on ClinicalTrials.gov

What this trial studies

This study investigates the relationship between insomnia and cardiovascular disease (CVD) risk in individuals diagnosed with posttraumatic stress disorder (PTSD). It aims to determine if treating insomnia through Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve biomarkers associated with CVD risk. Participants will undergo assessments of vascular function, blood pressure, and sympathetic nervous system activity, alongside their treatment. The study seeks to clarify the mechanisms linking PTSD, insomnia, and cardiovascular health.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-59 with chronic PTSD and a current diagnosis of insomnia disorder.

Not a fit: Patients with a history of cardiovascular events or those currently engaged in trauma-focused therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce cardiovascular risks for patients suffering from PTSD and insomnia.

How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated a potential link between insomnia treatment and improved cardiovascular outcomes in related populations.

Eligibility criteria

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)

Where this trial is running

Durham, North Carolina

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

Study contacts

• Principal investigator: Jean C Beckham, PhD — Duke Health
• Study coordinator: Tiffany Mosher, MA

Conditions Insomnia; Posttraumatic Stress Disorder; Cardiovascular Risk Factor