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
-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:
-Report on your sleep daily
-Be assigned to Group 1 or Group 2
---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
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698