Post Traumatic Stress Disorder Clinical Trial
Official title:
Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD)
This study is designed to test the effect of an explanation about the first sleep following trauma exposure, on the development of Post Traumatic Stress Disorder (PTSD) in the months following the traumatic event.
This is a Single blind, prospective, placebo controlled trial in which trauma victims are
randomized to receive an explanation about the first sleep following trauma exposure.
To provide a baseline prior the explanation, participants will receive a medical and
psychological evaluation. at this point the participants will be given one of two
explanations about sleep. The experimental group will receive an encouragement to deprived
sleep explanation, and the control group will receive an encouragement to sleep explanation,
Lorazepam 1mg will be offered to assist sleep. After two weeks the research assistant or
study psychiatrist will perform behavioral ratings and complete history details pertaining
to PTSD risk factors. Participants will be assessed again by the study psychiatrist or
research assistants at 1 & 3 months. Further assessments might be done at 6 & 13 months.
Eligible subjects will include men and women age 18-70, who have been exposed to an event
meeting the DSM-IV "A.1" criterion for trauma exposure, and who provide written, informed
consent to participate in the study.
Potential participants will be recruited from trauma victims who arrived at the Chaim Sheba
Medical Center Emergency Room.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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