Status:
COMPLETED
Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD)
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Anxiety Disorders
Mood Disorders
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 1...
Detailed Description
Posttraumatic stress disorder (PTSD) is a prevalent disorder in military samples associated with adverse emotional and health impacts and enormous health care costs, and it is often resistant to treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00393874
Start Date
October 1 2006
End Date
June 1 2011
Last Update
October 24 2016
Active Locations (1)
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1
Western Phychiatric Institute and Clinic, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213