ACTIVE_NOT_RECRUITING

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

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Conditions

InsomniaPosttraumatic Stress DisorderCardiovascular Risk Factor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-03-15
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04498754

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.

Ages Eligible for Study:40 Years to 59 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is between 40-59 years old;
  2. * 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);
  3. * Has a current diagnosis of ID as defined in the International Classification of Sleep Disorders (ICSD-3; American Academy of Sleep Medicine, 2014)
  1. * Has a history of CVD events, including myocardial infarction, stroke, transient ischemic attack, or coronary revascularization;
  2. * Has diagnosis of congestive heart failure or coronary artery disease based on results of diagnostic testing;
  3. * Has a current alcohol use or substance use disorder (those who meet lifetime but not current alcohol or substance use disorder will be included);
  4. * Is currently participating in or has recently (past 6 months) participated in an evidence-based trauma focused therapy for PTSD;
  5. * Has cognitive impairment as evidenced by less than 20 on the Montreal Cognitive Assessment scale (M0CA; Nasreddine et al., 2005);
  6. * Meets criteria for a psychotic spectrum disorder or bipolar disorder;
  7. * Has severely impaired hearing or speech;
  8. * Is pregnant;
  9. * 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.;
  10. * 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;
  11. * Works night shift;
  12. * Is participating in another interventional study to address insomnia;
  13. * Has prominent suicidal or homicidal ideation (as assessed through a clinical interview);
  14. * Has a serious/terminal illness or other health problem that would prohibit participation in the study;
  15. * Has nonclinically significant or sub-threshold insomnia as indicated by a score of \<8 on the Insomnia Severity Index;
  16. * Has seizures (based on clinical interview and self-report);
  17. * Has a body mass index of 45 or greater;
  18. * Has sleep apnea (based on the overnight assessment described below) or a positive sleep apnea screen;
  19. * 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);
  20. * Has an organic cause of sleep disruption that cannot be addressed by cognitive-behavioral changes (e.g., hyperthyroidism), as determined by the DSISD;
  21. * Has excessive daytime sleepiness, defined as a score \>15 on the Epworth Sleepiness Scale (ESS) or as determined by the DSISD;
  22. * 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
  23. * Cancels or no-shows for two or more Time 1 assessment appointments
  24. * Has uncontrolled hypertension (screening office BP \> 160/100 mm Hg)

Contacts and Locations

Principal Investigator

Jean C Beckham, PhD
PRINCIPAL_INVESTIGATOR
Duke Health
Andrew Sherwood, PhD
PRINCIPAL_INVESTIGATOR
Duke Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Duke University

  • Jean C Beckham, PhD, PRINCIPAL_INVESTIGATOR, Duke Health
  • Andrew Sherwood, PhD, PRINCIPAL_INVESTIGATOR, Duke Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-15
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2021-03-15
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Insomnia
  • Posttraumatic Stress Disorder
  • Cardiovascular Risk Factor