Status:
ACTIVE_NOT_RECRUITING
An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder
Lead Sponsor:
Duke University
Conditions:
Insomnia
Posttraumatic Stress Disorder
Eligibility:
All Genders
40-59 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04498754
Start Date
March 15 2021
End Date
December 30 2025
Last Update
July 3 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27706