Explanation About Sleep in Post Trauma Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Traumatic Stress Disorder, Sleep Deprivation

Intervention / Treatment
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* Behavioral: Explanation encouraging sleep
* Behavioral: Explanation discouraging sleep
* Drug: Lorazepam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons age 18-70, who have been exposed to an event meeting the DSM-IV A.1 criterion for trauma exposure. Persons who arrived at the Chaim Sheba Medical Center Emergency Room. Who provide written, informed consent to participate in the study - Exclusion Criteria: Physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by clinical judgment; Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period. Overt psychopathology, intoxication, or under the influence of substances. Evidence or history of schizophrenia, bipolar, other psychotic condition; Prior history of PTSD; Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure; Assessed serious suicide risk. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Encouragement to sleep<br>Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma | Behavioral: Explanation encouraging sleep<br>* An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.<br>Drug: Lorazepam<br>* Lorazepam 1 mg<br>|
| Experimental: Encouragement to deprived sleep<br>Encouraging explanation to deprived sleep in the first night post trauma | Behavioral: Explanation discouraging sleep<br>* An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep deprivation, PTSD,prevention