<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/NCT03012685</url>
  </required_header>
  <id_info>
    <org_study_id>16/EM/0326</org_study_id>
    <secondary_id>195832</secondary_id>
    <nct_id>NCT03012685</nct_id>
  </id_info>
  <brief_title>Sleep and Wellbeing Study</brief_title>
  <official_title>Relationship Between Sleep the First Night and Week After Trauma and Subsequent Intrusive Memories: a Prospective Study From the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Research Council Cognition and Brain Sciences Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Most people will experience a psychologically traumatic event, such as a life-threatening&#xD;
      accident, at some point in their life. In the initial days after such an event, it is common&#xD;
      to be haunted by intrusive memories: image-based memories of the event that spring to mind&#xD;
      unbidden. Intrusive memories can be distressing in their own right, but are also a hallmark&#xD;
      symptom of post-traumatic stress disorder (PTSD).&#xD;
&#xD;
      Sleep is important for many functions involved in how people perceive, respond to and&#xD;
      remember events, including stressful/traumatic events. Studies with patients who have&#xD;
      experienced traumatic events indicate that sleep disturbances in the first weeks post-trauma&#xD;
      are associated with later PTSD symptoms. However, in a previous study with healthy volunteers&#xD;
      exposed to experimental trauma (film footage), those who were sleep-deprived in the first&#xD;
      night, compared to those who slept, had fewer intrusive memories in the following week. This&#xD;
      raises the question of how sleep in the first night, but also the first week, after real-life&#xD;
      trauma is related to subsequent intrusive memories and PTSD symptoms.&#xD;
&#xD;
      The current study is an observational study of patients recruited from a hospital emergency&#xD;
      department after a traumatic event. After completing brief baseline questionnaires in the&#xD;
      emergency department, participants will be asked to fill in a daily diary of their sleep and&#xD;
      intrusive memories over the following week. Post-traumatic stress symptoms, anxiety and&#xD;
      depression will be assessed by post/online at one week and two months. Participants will be&#xD;
      telephoned after two months to complete an interview to assess PTSD symptoms and an optional&#xD;
      feedback interview.&#xD;
&#xD;
      This clinical study will be the first to assess the relationship between sleep in the first&#xD;
      night and week, and intrusive memories and mental wellbeing after real-life trauma. Findings&#xD;
      may have implications for developing simple sleep-based preventive treatments after trauma in&#xD;
      the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Daily diary of sleep and intrusive memories</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Actigraphy - to assess sleep timing and duration</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Event Scale-Revised (total score and subscales scores) - to assess post-trauma distress</measure>
    <time_frame>At 1 week and 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>At 1 week and 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician-Administered PTSD Scale</measure>
    <time_frame>At 2 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Feedback questionnaire</measure>
    <time_frame>At 2 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Optional feedback interview</measure>
    <time_frame>After 2 months</time_frame>
  </other_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Sleep</condition>
  <condition>Intrusive Memories</condition>
  <condition>Posttraumatic Stress Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to the John Radcliffe Hospital Emergency Department after a traumatic&#xD;
        event.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or over&#xD;
&#xD;
          -  Experienced or witnessed a traumatic event (i.e. one in which they were exposed to&#xD;
             death, threatened death, actual or threatened serious injury, or actual or threatened&#xD;
             sexual violence)&#xD;
&#xD;
          -  Present to the emergency department on the same day as the traumatic event&#xD;
&#xD;
          -  Report memory of the event&#xD;
&#xD;
          -  Fluent in written and spoken English&#xD;
&#xD;
          -  Alert and orientated, Glasgow Coma Scale score (GCS) = 15&#xD;
&#xD;
          -  Willing and able to give informed consent and complete study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Loss of consciousness&#xD;
&#xD;
          -  Current intoxication&#xD;
&#xD;
          -  History of severe mental illness&#xD;
&#xD;
          -  Current substance abuse or neurological condition&#xD;
&#xD;
          -  Currently suicidal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Emergency Department, John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>It is planned to make an anonymised database available via the Open Science Framework</ipd_description>
  </patient_data>
  <!-- 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/NCT03012685
org study id: 16/EM/0326
secondary id: 195832
nct id: NCT03012685
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Most people will experience a psychologically traumatic event, such as a life-threatening
      accident, at some point in their life. In the initial days after such an event, it is common
      to be haunted by intrusive memories: image-based memories of the event that spring to mind
      unbidden. Intrusive memories can be distressing in their own right, but are also a hallmark
      symptom of post-traumatic stress disorder (PTSD).

      Sleep is important for many functions involved in how people perceive, respond to and
      remember events, including stressful/traumatic events. Studies with patients who have
      experienced traumatic events indicate that sleep disturbances in the first weeks post-trauma
      are associated with later PTSD symptoms. However, in a previous study with healthy volunteers
      exposed to experimental trauma (film footage), those who were sleep-deprived in the first
      night, compared to those who slept, had fewer intrusive memories in the following week. This
      raises the question of how sleep in the first night, but also the first week, after real-life
      trauma is related to subsequent intrusive memories and PTSD symptoms.

      The current study is an observational study of patients recruited from a hospital emergency
      department after a traumatic event. After completing brief baseline questionnaires in the
      emergency department, participants will be asked to fill in a daily diary of their sleep and
      intrusive memories over the following week. Post-traumatic stress symptoms, anxiety and
      depression will be assessed by post/online at one week and two months. Participants will be
      telephoned after two months to complete an interview to assess PTSD symptoms and an optional
      feedback interview.

      This clinical study will be the first to assess the relationship between sleep in the first
      night and week, and intrusive memories and mental wellbeing after real-life trauma. Findings
      may have implications for developing simple sleep-based preventive treatments after trauma in
      the future.
observational model: Cohort
time perspective: Prospective
measure: Daily diary of sleep and intrusive memories
time frame: 1 week
measure: Actigraphy - to assess sleep timing and duration
time frame: 1 week
measure: Impact of Event Scale-Revised (total score and subscales scores) - to assess post-trauma distress
time frame: At 1 week and 2 months
measure: Hospital Anxiety and Depression Scale
time frame: At 1 week and 2 months
measure: Clinician-Administered PTSD Scale
time frame: At 2 months
measure: Feedback questionnaire
time frame: At 2 months
measure: Optional feedback interview
time frame: After 2 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Yes
ipd description: It is planned to make an anonymised database available via the Open Science Framework