An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder
概览
- 阶段
- 不适用
- 干预措施
- Cognitive Behavior Therapy for Insomnia
- 疾病 / 适应症
- Insomnia
- 发起方
- Duke University
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in 10-year atherosclerotic cardiovascular disease risk
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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)
排除标准
- •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;
研究组 & 干预措施
Cognitive Behavior Therapy for Insomnia (CBT-I)
Participants assigned to this arm will receive eight sessions of a well-established, evidence-based therapy called cognitive behavior therapy for insomnia (CBT-I).
干预措施: Cognitive Behavior Therapy for Insomnia
Minimal Contact Control Condition
Participants assigned to this condition will be contacted every week for eight weeks and monitored regarding their insomnia symptoms.
干预措施: Weekly phone contacts
结局指标
主要结局
Change in 10-year atherosclerotic cardiovascular disease risk
时间窗: Baseline and 6-month follow-up
The risk of having a primary atherosclerotic cardiovascular disease event within 10 years will be based upon the pooled cohort equations model developed by the American College of Cardiology/American Heart Association.
Change in nighttime blood pressure dipping
时间窗: Baseline and 6-month follow-up
Systolic and diastolic blood pressure dipping measured by 24-hour ambulatory blood pressure monitoring, and defined as the percent change in blood pressure from the wake period to the nighttime sleep period.
Change in nighttime sympathetic nervous system activity
时间窗: Baseline and 6-month follow-up
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Change in insomnia severity
时间窗: Baseline and 6-month follow-up
Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.
Change in vascular endothelial function
时间窗: Baseline and 6-month follow-up
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery.
Change in nighttime blood pressure
时间窗: Baseline and 6-month follow-up
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Change in sleep efficiency
时间窗: Baseline and 6-month follow-up
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
Change in nighttime blood pressure
时间窗: Baseline and post-treatment (approximately eight weeks)
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Change in nighttime blood pressure dipping
时间窗: Baseline and post-treatment (approximately eight weeks)
Systolic and diastolic blood pressure dipping measured by 24-hour ambulatory blood pressure monitoring, and defined as the percent change in blood pressure from the wake period to the nighttime sleep period.
Change in vascular endothelial function
时间窗: Baseline and post-treatment (approximately eight weeks)
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery. V
Change in nighttime sympathetic nervous system activity
时间窗: Baseline and post-treatment (approximately eight weeks)
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Change in 10-year atherosclerotic cardiovascular disease risk
时间窗: Baseline and post-treatment (approximately eight weeks)
The risk of having a primary atherosclerotic cardiovascular disease event within 10 years will be based upon the pooled cohort equations model developed by the American College of Cardiology/American Heart Association.
Change in insomnia severity
时间窗: Baseline and post-treatment (approximately eight weeks)
Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.
Change in sleep efficiency
时间窗: Baseline and post-treatment (approximately eight weeks)
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
次要结局
- Change in subjective sleep quality(Baseline and post-treatment (approximately eight weeks))
- Change in quality of life(Baseline and post-treatment (approximately eight weeks))
- Change in subjective sleep quality(Baseline and 6-month follow-up)
- Change in quality of life(Baseline and 6-month follow-up)