ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

September 5, 2012
September 12, 2012
October 10, 2012
October 2012
September 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01684085 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)
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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
  • Post Traumatic Stress Disorder
  • Sleep Deprivation
  • 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
  • Placebo Comparator: Encouragement to sleep
    Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma
    Interventions:
    • Behavioral: Explanation encouraging sleep
    • Drug: Lorazepam
  • Experimental: Encouragement to deprived sleep
    Encouraging explanation to deprived sleep in the first night post trauma
    Intervention: Behavioral: Explanation discouraging sleep
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
70
Same as current
Not Provided
September 2014   (Final data collection date for primary outcome measure)

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. -
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01684085
SHEBA-12-9175-JZ-CTIL
No
Not Provided
Not Provided
Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Joseph Zohar, MD Department of Psychiatry, Chaim Sheba Medical Center, Israel
Sheba Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP