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

Launched by DUKE UNIVERSITY · Aug 3, 2020

Keywords

ClinConnect Summary

This clinical trial is examining how treating insomnia can help reduce the risk of heart problems in people who have posttraumatic stress disorder (PTSD). PTSD can make life very difficult, and it often comes with sleep issues like insomnia. Poor sleep can lead to a higher chance of heart disease, so the researchers want to see if improving sleep can also lower this risk in patients with PTSD.

To participate, you need to be between 40 and 59 years old and diagnosed with chronic PTSD and insomnia. The study is currently looking for participants, and if you join, you can expect to receive treatment for your insomnia while being monitored for any changes in your heart health. It’s important to know that certain medical conditions and treatments may exclude you from participating, such as having a history of serious heart problems or currently being on certain medications. If you’re interested, this could be a valuable opportunity to improve both your sleep and your overall health.

Gender

ALL

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)