Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD)
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to evaluate and compare the effects of experimental
treatments aimed at improving insomnia and nightmares in men and women military veterans
between the ages of 18 and 60 years old, and who have a condition called Posttraumatic Stress
Disorder. Insomnia refers to difficulty falling or staying asleep, although enough time is
allowed for sleeping. Insomnia is also associated with daytime consequences, such as lack of
energy, irritability, and difficulty concentrating. Nightmares are bad dreams that may or may
not awaken the sleeper, and that cause discomfort during the daytime.
Chronic Posttraumatic Stress Disorder (PTSD) refers to symptoms that occur after someone
experienced or witnessed a life-threatening event, and that persist for three months or more
after the event. Symptoms include flashbacks, nightmares, feelings of detachment from others,
sleep disturbances, irritability, anxiety, and efforts to avoid people and places associated
with the life-threatening event. These symptoms occur after a life-threatening event.
Symptoms that persist for more than one month indicate the presence of PTSD. In the present
study, we will study people with chronic PTSD, which refers to PTSD symptoms that persist for
more than 3 months.
Efficacy of a treatment is defined as the capacity to produce the desired effects. In this
study, we will evaluate and compare the capacity of two active experimental treatments to
reduce insomnia and nightmares associated with PTSD, and one inactive intervention, called a
placebo, for people who continue to have sleep difficulties despite receiving treatment with
an antidepressant medication called a selective serotonin reuptake inhibitor (SSRI, like
Prozac, Paxil, Zoloft, Celexa). The two active experimental treatments are a medication,
prazosin, and a brief behavioral intervention, which involves exercises and techniques to
reduce nightmares and improve sleep quality. Prazosin is an approved medication by the Food
and Drug Administration (FDA) against high blood pressure, but is not FDA-approved for
posttraumatic insomnia and nightmares.
Phase:
N/A
Details
Lead Sponsor:
University of Pittsburgh
Collaborators:
U.S. Army Medical Research and Development Command U.S. Army Medical Research and Materiel Command