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

Description

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.

Conditions

Insomnia, Posttraumatic Stress Disorder, Cardiovascular Risk Factor

Study Overview

Study Details

Study overview

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.

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

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

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

Durham

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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)

Ages Eligible for Study

40 Years to 59 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Jean C Beckham, PhD, PRINCIPAL_INVESTIGATOR, Duke Health

Andrew Sherwood, PhD, PRINCIPAL_INVESTIGATOR, Duke Health

Study Record Dates

2024-12-31