Back to resultsAn Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder
Primary Purpose
Insomnia, Posttraumatic Stress Disorder, Cardiovascular Risk Factor
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy for Insomnia
Weekly phone contacts
Sponsored by
About this trial
This is an interventional other trial for Insomnia
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 <14 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);
- 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
Sites / Locations
- Duke University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cognitive Behavior Therapy for Insomnia (CBT-I)
Minimal Contact Control Condition
Arm Description
Participants assigned to this arm will receive eight sessions of a well-established, evidence-based therapy called cognitive behavior therapy for insomnia (CBT-I).
Participants assigned to this condition will be contacted every week for eight weeks and monitored regarding their insomnia symptoms.
Outcomes
Primary Outcome Measures
Change in nighttime blood pressure
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Change in nighttime blood pressure
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Change in nighttime blood pressure dipping
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 blood pressure dipping
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
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery. V
Change in vascular endothelial function
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery.
Change in nighttime sympathetic nervous system activity
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Change in nighttime sympathetic nervous system activity
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
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 10-year atherosclerotic cardiovascular disease risk
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
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 insomnia severity
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
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
Change in sleep efficiency
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
Secondary Outcome Measures
Change in subjective sleep quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index. The scale has a score range of 0 to 21, with lower scores on this measure indicating better sleep quality.
Change in subjective sleep quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index.scale has a score range of 0 to 21, with lower scores on this measure indicating better sleep quality.
Change in quality of life
Quality of life will be measured using the Short Form-36 Health Survey. Scores on this measure range from 0 to 100, with higher scores indicating better quality of life.
Change in quality of life
Quality of life will be measured using the Short Form-36 Health Survey. Scores on this measure range from 0 to 100, with higher scores indicating better quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04498754
Brief Title
An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder
Official Title
An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Posttraumatic Stress Disorder, Cardiovascular Risk Factor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants who are originally assigned to the minimal contact control condition will be invited to receive the active condition treatment after their study involvement has been completed, but no additional data will be collected from them.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavior Therapy for Insomnia (CBT-I)
Arm Type
Experimental
Arm Description
Participants assigned to this arm will receive eight sessions of a well-established, evidence-based therapy called cognitive behavior therapy for insomnia (CBT-I).
Arm Title
Minimal Contact Control Condition
Arm Type
Other
Arm Description
Participants assigned to this condition will be contacted every week for eight weeks and monitored regarding their insomnia symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy for Insomnia
Other Intervention Name(s)
CBT-I
Intervention Description
8 sessions of treatment for insomnia.
Intervention Type
Behavioral
Intervention Name(s)
Weekly phone contacts
Intervention Description
Weekly calls to monitor insomnia symptoms.
Primary Outcome Measure Information:
Title
Change in nighttime blood pressure
Description
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in nighttime blood pressure
Description
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Time Frame
Baseline and 6-month follow-up
Title
Change in nighttime blood pressure dipping
Description
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.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in nighttime blood pressure dipping
Description
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.
Time Frame
Baseline and 6-month follow-up
Title
Change in vascular endothelial function
Description
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery. V
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in vascular endothelial function
Description
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery.
Time Frame
Baseline and 6-month follow-up
Title
Change in nighttime sympathetic nervous system activity
Description
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in nighttime sympathetic nervous system activity
Description
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Time Frame
Baseline and 6-month follow-up
Title
Change in 10-year atherosclerotic cardiovascular disease risk
Description
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.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in 10-year atherosclerotic cardiovascular disease risk
Description
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.
Time Frame
Baseline and 6-month follow-up
Title
Change in insomnia severity
Description
Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in insomnia severity
Description
Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.
Time Frame
Baseline and 6-month follow-up
Title
Change in sleep efficiency
Description
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in sleep efficiency
Description
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
Time Frame
Baseline and 6-month follow-up
Secondary Outcome Measure Information:
Title
Change in subjective sleep quality
Description
Sleep quality will be measured by the Pittsburgh Sleep Quality Index. The scale has a score range of 0 to 21, with lower scores on this measure indicating better sleep quality.
Time Frame
Baseline and 6-month follow-up
Title
Change in subjective sleep quality
Description
Sleep quality will be measured by the Pittsburgh Sleep Quality Index.scale has a score range of 0 to 21, with lower scores on this measure indicating better sleep quality.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in quality of life
Description
Quality of life will be measured using the Short Form-36 Health Survey. Scores on this measure range from 0 to 100, with higher scores indicating better quality of life.
Time Frame
Baseline and 6-month follow-up
Title
Change in quality of life
Description
Quality of life will be measured using the Short Form-36 Health Survey. Scores on this measure range from 0 to 100, with higher scores indicating better quality of life.
Time Frame
Baseline and post-treatment (approximately eight weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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 <14 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);
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Mosher, MA
Phone
(919) 684-1079
Email
tiffany.mosher@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Kirby, MS
Phone
919-286-0411
Ext
175526
Email
angela.kirby@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean C Beckham, PhD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Sherwood, PhD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela C. Kirby, M.S.
Phone
919-286-0411
Ext
5526
Email
angela.kirby@va.gov
First Name & Middle Initial & Last Name & Degree
Jean C Beckham, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.
Learn more about this trial
An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder
We'll reach out to this number within 24 hrs