An interventional study of Explanation encouraging sleep and Explanation discouraging sleep in Post Traumatic Stress Disorder and Sleep Deprivation, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-10.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Prevention
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.
300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.
This study's planned enrollment of 70 is above the median of 45 across 248 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma
Behavioral: Explanation encouraging sleep · Drug: Lorazepam
Encouraging explanation to deprived sleep in the first night post trauma
Behavioral: Explanation discouraging sleep
An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.
An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event.
Lorazepam 1 mg
PTSD severity as measured by CAPS
The primary outcome is PTSD severity at the end of the trial .This will be determined using the Clinician Administered PTSD Scale (CAPS), a scale with established reliability and good psychometric properties.
Time frame: 4 months
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center