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

Insomnia Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Posttraumatic stress disorder (PTSD) is a disabling and costly psychiatric disorder that is estimated to occur in 20% of individuals who are exposed to a traumatic event and is chronic in one third of cases. In addition to its negative impact on quality of life, there is substantial evidence that PTSD (even after controlling for depression and other risk factors) is associated with a markedly increased risk of cardiovascular morbidity and mortality. However, the mechanisms for the association between PTSD and cardiovascular disease (CVD) risk are not well understood. Although adverse health behaviors, including cigarette smoking, alcohol abuse and poor medication adherence are common in PTSD, recent prospective studies show that they do not account for the magnitude of CVD risk among individuals with PTSD. The investigators propose to test our central hypothesis by evaluating whether CBT-I results in improved biomarkers of CVD risk among those with PTSD. Well established biomarkers of CVD related morbidity and mortality will be used including measures of vascular endothelial function measured by brachial artery flow-mediated dilation (FMD), nighttime blood pressure (BP) dipping measured using 24-hour ambulatory blood pressure monitoring (ABPM), and sympathetic nervous system (SNS) activity as measured by 24-hour urinary catecholamines. Investigators will also assess lipid profile, which along with BP is a modifiable component with marked impact on the atherosclerotic cardiovascular disease (ASCVD) risk score. The primary sleep parameter of interest is objectively-measured sleep efficiency (through actigraphy), although self-report insomnia measures and sleep related arousal will also be measured. The rationale for the proposed research is that once it is established that insomnia is an important and modifiable symptom conveying increased CVD risk in this population, the development of new and innovative approaches to integrating insomnia treatment with PTSD-focused interventions can be developed. 150 men and women with comorbid PTSD and insomnia disorder will be randomly assigned with a 2:1 ratio to 8-week cognitive behavioral therapy-Insomnia (CBT-I) intervention or a waiting period control condition. Sleep quality parameters and CVD risk biomarkers will be assessed at pre-randomization baseline, post-intervention, and at a 6-month follow-up. The study is designed to evaluate the association between insomnia and CVD risk biomarkers among persons with PTSD, and determine whether improvements in insomnia symptoms are associated with improvements in CVD risk biomarkers. ;

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Insomnia
• Posttraumatic Stress Disorder
• Sleep Initiation and Maintenance Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT04498754
• Study type: Interventional
• Source: Duke University
• Contact: Tiffany Mosher, MA
• Phone: (919) 684-1079
• Email: tiffany.mosher@duke.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2021
• Completion date: December 31, 2024