Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Prazosin

Criteria

Inclusion Criteria:

• Military veterans

• Age between 18 and 55 years old

• Reports of insomnia and nightmares

• Current diagnosis of PTSD

• Currently treated with an SSRI.

• Medications and dosages will remain unchanged for the duration of the study

• Participants will agree to remain in ongoing counseling services they may be receiving prior to study entry.

• Able to read and write English

• Provision of written informed consent

Exclusion Criteria:

• Current, severe, untreated Major Depressive Disorder

• Current history of suicidality requiring hospitalization

• Current history (past 6 months) of substance or alcohol abuse

• Currently actively psychotic or bipolar disorder (past year)

• Resting blood pressure < 90/60 at the screening physical examination

• Heart rate > 100 beats/minutes

• Use of an alpha-1 antagonist agent or beta-blocker

• Refusal to follow the safety measures

• Unexpected, untreated, or serious EKG findings

• Medications and/or dosage changed in the past two months

• Unstable medical condition

• Pregnant or breast-feeding women

• Apnea-hypopnea index (AHI) > 15

• Refusal to provide information relevant to selection criteria