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Post Traumatic Stress Disorder | Explanation About Sleep in Post Trauma Patients

Post Traumatic Stress Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Persons age 18-70, who have been exposed to an event meeting the DSM-IV \"A.1\" criterion for trauma exposure. 2. Persons who arrived at the Chaim Sheba Medical Center Emergency Room. 3. Who provide written, informed consent to participate in the study - Exclusion Criteria: 1. 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; 2. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period. 3. Overt psychopathology, intoxication, or under the influence of substances. 4. Evidence or history of schizophrenia, bipolar, other psychotic condition; 5. Prior history of PTSD; 6. Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure; 7. Assessed serious suicide risk. -

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Post Traumatic Stress Disorder

Sleep Deprivation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Explanation encouraging sleepAn explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.

Behavioral:Explanation discouraging sleepAn explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event.

Drug:LorazepamLorazepam 1 mg

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Encouragement to sleepEncouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma

Encouragement to deprived sleepEncouraging explanation to deprived sleep in the first night post trauma

Study Status

Unknown status

Start Date: October 2012

Completed Date:

Phase: N/A

Type: Interventional

Design:

Primary Outcome: PTSD severity as measured by CAPS

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Joseph Zohar, MD

Lead Sponsor: Sheba Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01684085

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