Insomnia PTSD - Clinical Trial

What is the Purpose of this Study?

We are doing this study to understand how your sleep can effect biomarkers of heart disease in people with posttraumatic stress disorder (PTSD) and insomnia.

What is the Condition Being Studied?

Insomnia and Posttraumatic Stress Disorder

Who Can Participate in the Study?

Adults ages 40-59 who:

  • Have or could possibly have PTSD
  • Have insomnia
Age Group
Adults

What is Involved?

If you choose to join this study, and are eligible to participate, you will complete some activities for a week, which include:

  • Wear a wristband monitor for one week (we will give this to you)
  • Keep a sleep diary for 1 week while you wear the wristband
  • Collect your urine for 24 hours
  • Wear a blood pressure monitor for 24 hours
  • Provide a blood sample
  • An ultrasound on your arm (done in-person at the clinic)

After the first week, you will begin reporting on your sleep each day and get a random assignment (like a coin flip) to 1 of 2 groups:

  • Group 1 will get 8 weeks of sessions of in-person treatment for insomnia.
  • Group 2 will have the study coordinator contact you once a week to check in about your sleep symptoms.

After that, you will:

  • Complete the same activities as you did at the beginning of the study
  • Come in six months later to do the activities again
  • Study Details

    Full Title
    An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients with Posttraumatic Stress Disorder
    Principal Investigator
    Jean Beckham
    Protocol Number
    IRB: PRO00100446
    NCT: NCT04498754
    Phase
    Phase N/A
    ClinicalTrials.gov
    Enrollment Status
    Open for Enrollment