NCT01684085

Explanation About Sleep in Post Trauma Patients

Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Post Traumatic Stress Disorder
• Sleep Deprivation

Interventions

Type	Name	Description
BEHAVIORAL	Explanation encouraging sleep	An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.
BEHAVIORAL	Explanation discouraging sleep	An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event.
DRUG	Lorazepam	Lorazepam 1 mg

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-09-01
• First posted: 2012-09-12
• Last updated: 2012-10-10

Locations

1 site across 1 country: Israel