<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01684085</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-12-9175-JZ-CTIL</org_study_id>
    <nct_id>NCT01684085</nct_id>
  </id_info>
  <brief_title>Explanation About Sleep in Post Trauma Patients</brief_title>
  <official_title>Explanation About Sleep Given After Traumatic Event, and Its Effect on the Trajectory of Post Traumatic Stress Disorder (PTSD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to test the effect of an explanation about the first sleep following&#xD;
      trauma exposure, on the development of Post Traumatic Stress Disorder (PTSD) in the months&#xD;
      following the traumatic event.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Single blind, prospective, placebo controlled trial in which trauma victims are&#xD;
      randomized to receive an explanation about the first sleep following trauma exposure.&#xD;
&#xD;
      To provide a baseline prior the explanation, participants will receive a medical and&#xD;
      psychological evaluation. at this point the participants will be given one of two&#xD;
      explanations about sleep. The experimental group will receive an encouragement to deprived&#xD;
      sleep explanation, and the control group will receive an encouragement to sleep explanation,&#xD;
      Lorazepam 1mg will be offered to assist sleep. After two weeks the research assistant or&#xD;
      study psychiatrist will perform behavioral ratings and complete history details pertaining to&#xD;
      PTSD risk factors. Participants will be assessed again by the study psychiatrist or research&#xD;
      assistants at 1 &amp; 3 months. Further assessments might be done at 6 &amp; 13 months.&#xD;
&#xD;
      Eligible subjects will include men and women age 18-70, who have been exposed to an event&#xD;
      meeting the DSM-IV &quot;A.1&quot; criterion for trauma exposure, and who provide written, informed&#xD;
      consent to participate in the study.&#xD;
&#xD;
      Potential participants will be recruited from trauma victims who arrived at the Chaim Sheba&#xD;
      Medical Center Emergency Room.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PTSD severity as measured by CAPS</measure>
    <time_frame>4 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <condition>Sleep Deprivation</condition>
  <arm_group>
    <arm_group_label>Encouragement to sleep</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Encouragement to deprived sleep</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Encouraging explanation to deprived sleep in the first night post trauma</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Explanation encouraging sleep</intervention_name>
    <description>An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.</description>
    <arm_group_label>Encouragement to sleep</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Explanation discouraging sleep</intervention_name>
    <description>An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event.</description>
    <arm_group_label>Encouragement to deprived sleep</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lorazepam</intervention_name>
    <description>Lorazepam 1 mg</description>
    <arm_group_label>Encouragement to sleep</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Persons age 18-70, who have been exposed to an event meeting the DSM-IV &quot;A.1&quot;&#xD;
             criterion for trauma exposure.&#xD;
&#xD;
          2. Persons who arrived at the Chaim Sheba Medical Center Emergency Room.&#xD;
&#xD;
          3. Who provide written, informed consent to participate in the study -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Physical injury that would contraindicate participation or interfere with a subject's&#xD;
             ability to give informed consent or cooperate with the screening or collection of&#xD;
             initial measures. Examples include severe burn injury, life-threatening medical or&#xD;
             surgical condition, condition requiring surgical intervention under general&#xD;
             anesthesia, as indicated by clinical judgment;&#xD;
&#xD;
          2. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to&#xD;
             which the subject is likely to be re-exposed during the study period.&#xD;
&#xD;
          3. Overt psychopathology, intoxication, or under the influence of substances.&#xD;
&#xD;
          4. Evidence or history of schizophrenia, bipolar, other psychotic condition;&#xD;
&#xD;
          5. Prior history of PTSD;&#xD;
&#xD;
          6. Current or past history of dementia, amnesia, or other cognitive disorder predating&#xD;
             trauma exposure;&#xD;
&#xD;
          7. Assessed serious suicide risk. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Zohar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry, Chaim Sheba Medical Center, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center</name>
      <address>
        <city>Tel Hashomer</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>October 7, 2012</last_update_submitted>
  <last_update_submitted_qc>October 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sleep deprivation, PTSD,prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lorazepam</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01684085
org study id: SHEBA-12-9175-JZ-CTIL
nct id: NCT01684085
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: PTSD severity as measured by CAPS
time frame: 4 months
description: 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.
arm group label: Encouragement to sleep
arm group type: Placebo Comparator
description: Encouraging explanation to sleep, rest and receiving Lorazepam 1mg in the first night post trauma
arm group label: Encouragement to deprived sleep
arm group type: Experimental
description: Encouraging explanation to deprived sleep in the first night post trauma
intervention type: Behavioral
intervention name: Explanation encouraging sleep
description: An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.
arm group label: Encouragement to sleep
intervention type: Behavioral
intervention name: Explanation discouraging sleep
description: An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event.
arm group label: Encouragement to deprived sleep
intervention type: Drug
intervention name: Lorazepam
description: Lorazepam 1 mg
arm group label: Encouragement to sleep
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph Zohar, MD
role: Principal Investigator
affiliation: Department of Psychiatry, Chaim Sheba Medical Center, Israel
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Sleep Deprivation
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Lorazepam