Funding Agency: Department of Defense
On-Going Research Projects

Title: Efficacy of Adjunct Sleep Interventions for PTSD (EASI-PTSD)
Synopsis: This project will investigate two different interventions for sleep disturbances associated with PTSD in men and women veterans.
Overall Summary: Sleep deprivation and sleep disruptions are consequences of increased stress, but they can, in themselves, adversely affect cognitive performance, physical functions, and mood. Although sleep deprivation is inherent to combat settings and active duty, sleep disruption resulting from acute and chronic stress reactions can further adversely affect cognitive processes, task performance, and combat. Sleep disturbances also are a core feature of chronic stress reactions, such a post-traumatic stress disorder (PTSD), that independently contribute to poor physical and mental health outcomes and associated enormous health care costs. However, there are no available guidelines to treat acute or chronic stress-related sleep disturbances.
Overall Project Objective: The objective of this study is to investigate the efficacy and durability of two very different interventions for sleep disturbances associated with PTSD in men and women veterans. The general hypothesis is that active adjunctive sleep treatments will improve PTSD-related sleep and nightmare complaints; reduce daytime PTSD symptoms, depression, and anxiety; and improve health-related quality of life and perceived health compared to a placebo condition.
Results to Date: During the first year of the study, all staff members were hired and completed all necessary training as requested by the University of Pittsburgh and VA Pittsburgh Healthcare System (VAPHS) Institutional Review Board (IRB). IRB approvals have been acquired and posters and brochures have been developed. Recruitment was also initiated via television advertisements and contacting clinicians at the VAPHS PTSD Clinic and OIF/OEF clinics. To date, a total of 59 of 78 individuals who were contacted or referred to the team were reached by the research coordinator and initiated the telephone screening. Of those contacted, 11 have enrolled in the study and 8 are scheduled for a consent interview. Individuals were not included, or declined, due to time constraints, medication issues, and other exclusionary information disclosed.
Project: DOD-164
Agency: Department Of Defense
Location: University of Pittsburgh
P.I. Name: Anne Germain
Status: Ongoing
Study Start Date: February 17, 2006
Estimated Completion Date: March 16, 2010
Specific Aims: (1) To investigate the efficacy of prazosin and a behavioral sleep intervention on primary outcomes measures of sleep as determined by sleep diary parameters, laboratory-based sleep measures, and validated sleep questionnaires compared to placebo. (2) To evaluate the effects of active sleep interventions on secondary outcome measures of daytime PTSD symptoms, depression, anxiety, and health-related quality of life. (3) To examine the durability of sleep treatment effects of primary and secondary outcome measures 4 months post-treatment. A secondary aim is to examine predictors of sleep treatment response.
Methodology: The efficacy of the two sleep interventions will be assessed in a randomized controlled trial that include a placebo arm in 90 men and women veterans between the ages of 18 and 55 years old who experience sleep disturbances despite receiving a selective serotonin reuptake inhibitor for PTSD. Treatments will be administered over an 8-week period. Changes in sleep, PTSD symptoms, depression, anxiety, and health-related quality of life will be compared post-treatment, and at 4 months post-treatment.
Publications:
No Publications at this time...



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