Explanation About Sleep in Post Trauma Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01684085|
Recruitment Status : Unknown
Verified October 2012 by Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : September 12, 2012
Last Update Posted : October 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder Sleep Deprivation||Behavioral: Explanation encouraging sleep Behavioral: Explanation discouraging sleep Drug: Lorazepam||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD)|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||September 2014|
Placebo Comparator: Encouragement to sleep
Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma
Behavioral: Explanation encouraging sleep
An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.Drug: Lorazepam
Lorazepam 1 mg
Experimental: Encouragement to deprived sleep
Encouraging explanation to deprived sleep in the first night post trauma
Behavioral: Explanation discouraging sleep
An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event.
- PTSD severity as measured by CAPS [ Time Frame: 4 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684085
|Chaim Sheba Medical Center|
|Tel Hashomer, Israel, 52621|
|Principal Investigator:||Joseph Zohar, MD||Department of Psychiatry, Chaim Sheba Medical Center, Israel|