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

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)