Explanation About Sleep in Post Trauma Patients

Overview[ - collapse ][ - ]

Purpose 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.
ConditionPost Traumatic Stress Disorder
Sleep Deprivation
InterventionBehavioral: Explanation encouraging sleep
Behavioral: Explanation discouraging sleep
Drug: Lorazepam
PhaseN/A
SponsorSheba Medical Center
Responsible PartySheba Medical Center
ClinicalTrials.gov IdentifierNCT01684085
First ReceivedSeptember 5, 2012
Last UpdatedOctober 7, 2012
Last verifiedOctober 2012

Tracking Information[ + expand ][ + ]

First Received DateSeptember 5, 2012
Last Updated DateOctober 7, 2012
Start DateOctober 2012
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresPTSD severity as measured by CAPS [Time Frame: 4 months] [Designated as safety issue: No]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.
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleExplanation About Sleep in Post Trauma Patients
Official TitleExplanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD)
Brief 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.
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Condition
  • Post Traumatic Stress Disorder
  • Sleep Deprivation
InterventionBehavioral: 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
Study Arm (s)
  • Placebo Comparator: Encouragement to sleep
    Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma
  • Experimental: Encouragement to deprived sleep
    Encouraging explanation to deprived sleep in the first night post trauma

Recruitment Information[ + expand ][ + ]

Recruitment StatusNot yet recruiting
Estimated Enrollment70
Estimated Completion DateNot Provided
Estimated Primary Completion DateSeptember 2014
Eligibility Criteria
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. -
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesIsrael

Administrative Information[ + expand ][ + ]

NCT Number NCT01684085
Other Study ID NumbersSHEBA-12-9175-JZ-CTIL
Has Data Monitoring CommitteeNo
Information Provided BySheba Medical Center
Study SponsorSheba Medical Center
CollaboratorsNot Provided
Investigators Principal Investigator: Joseph Zohar, MD Department of Psychiatry, Chaim Sheba Medical Center, Israel
Verification DateOctober 2012

Locations[ + expand ][ + ]

Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621