<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/NCT04455360</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol version 1.2</org_study_id>
    <nct_id>NCT04455360</nct_id>
  </id_info>
  <brief_title>Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial</brief_title>
  <acronym>Cov-EMERALD</acronym>
  <official_title>EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dorset HealthCare University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary objective is to evaluate the feasibility of delivering an online early Eye Movement&#xD;
      Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who&#xD;
      have survived Covid-19 related critical illness, within the context of a randomised&#xD;
      controlled trial (RCT).&#xD;
&#xD;
      This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in&#xD;
      reducing psychological symptoms, for adult survivors of intensive care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A significant number of patients worldwide, have been admitted to intensive care suffering&#xD;
      from Covid-19 related organ failure. Patients who survive a period of critical illness have a&#xD;
      disproportionately high chance of suffering from significant and persistant poor&#xD;
      psychological outcomes.&#xD;
&#xD;
      Eye-Movement Desensitisation and Reprocessing (EMDR) has reduced incidence of psychological&#xD;
      morbidity in war veterans and victims of man-made and natural disasters. Small studies have&#xD;
      also shown it to be effective in healthcare settings, within the Emergency department,&#xD;
      following cancer diagnosis and implantation of cardioverter defibrillators. EMDR is validated&#xD;
      by UK National Institute of Clinical Excellence guidance for use in treating adult onset&#xD;
      PTSD.&#xD;
&#xD;
      Because of ongoing social distancing guidance our study programme aims to investigate whether&#xD;
      it is feasible to treat patients with an early online Eye Movement Desensitisation&#xD;
      Reprocessing (EMDR) intervention, delivered soon after hospital discharge and whether this&#xD;
      intervention will improve psychological outcome for survivors of critical illness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">September 20, 2021</completion_date>
  <primary_completion_date type="Actual">September 20, 2021</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Patient reported outcomes at 6-months post-hospital discharge</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints</measure>
    <time_frame>12 months</time_frame>
    <description>Feasibility will be determined by the following measures:&#xD;
Able to recruit &gt;30% of eligible patients approached&#xD;
Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention.&#xD;
Protocol adherence&#xD;
Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility.&#xD;
Outcome measures completed in 75% or more of trial participants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-Traumatic stress disorder</measure>
    <time_frame>6 months post-hospital discharge</time_frame>
    <description>The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>6 months</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>6 months post-hospital discharge</time_frame>
    <description>Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>6 months post-hospital discharge</time_frame>
    <description>EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health and disability</measure>
    <time_frame>6 months post-hospital discharge</time_frame>
    <description>WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>6 months post-hospital discharge</time_frame>
    <description>Wrist worn physical activity monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status</measure>
    <time_frame>6 months post-hospital discharge</time_frame>
    <description>Patient generated subjective global assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <condition>Intensive Care Psychiatric Disorder</condition>
  <condition>Anxiety Disorders</condition>
  <condition>Depression</condition>
  <condition>Critical Care</condition>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>EMDR R-TEP intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a minimum of 2 and a maximum of 8 online EMDR R-TEP sessions, starting within 3-months of hospital discharge. Sessions will be delivered online by experienced, suitably trained and registered psychological practitioners.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive standard post-hospital discharge care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol</intervention_name>
    <description>EMDR is a form of psychotherapy treatment whereby the client verbally relates a narrative of a traumatic episode or emotionally disturbing material in brief sequential doses while simultaneously focusing on an external stimulus. The EMDR Recent-Traumatic Events protocol (R-TEP) aims to enable an individual to process memories of the event in order to reduce psychological morbidity. EMDR R-TEP should be delivered within 3-months of the onset of a traumatic event.</description>
    <arm_group_label>EMDR R-TEP intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute admission to Critical Care who have required mechanical ventilation for at least&#xD;
             24 hours&#xD;
&#xD;
          -  PCR confirmed Covid-19 positive&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  Capacity to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute brain injury&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Pre-existing psychotic diagnosis&#xD;
&#xD;
          -  Not expected to survive post-hospital discharge&#xD;
&#xD;
          -  Refusal to grant consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael P Grocott, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Southampton NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southampton</city>
        <state>Hamphsire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EMDR</keyword>
  <keyword>Eye movement desensitisation and reprocessing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04455360
org study id: Protocol version 1.2
nct id: NCT04455360
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary objective is to evaluate the feasibility of delivering an online early Eye Movement
      Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who
      have survived Covid-19 related critical illness, within the context of a randomised
      controlled trial (RCT).

      This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in
      reducing psychological symptoms, for adult survivors of intensive care.
A significant number of patients worldwide, have been admitted to intensive care suffering
      from Covid-19 related organ failure. Patients who survive a period of critical illness have a
      disproportionately high chance of suffering from significant and persistant poor
      psychological outcomes.

      Eye-Movement Desensitisation and Reprocessing (EMDR) has reduced incidence of psychological
      morbidity in war veterans and victims of man-made and natural disasters. Small studies have
      also shown it to be effective in healthcare settings, within the Emergency department,
      following cancer diagnosis and implantation of cardioverter defibrillators. EMDR is validated
      by UK National Institute of Clinical Excellence guidance for use in treating adult onset
      PTSD.

      Because of ongoing social distancing guidance our study programme aims to investigate whether
      it is feasible to treat patients with an early online Eye Movement Desensitisation
      Reprocessing (EMDR) intervention, delivered soon after hospital discharge and whether this
      intervention will improve psychological outcome for survivors of critical illness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Patient reported outcomes at 6-months post-hospital discharge
measure: Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints
time frame: 12 months
description: Feasibility will be determined by the following measures:
Able to recruit >30% of eligible patients approached
Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention.
Protocol adherence
Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility.
Outcome measures completed in 75% or more of trial participants
measure: Post-Traumatic stress disorder
time frame: 6 months post-hospital discharge
description: The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms
measure: Anxiety and depression
time frame: 6 months
description: Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression
measure: Cognitive function
time frame: 6 months post-hospital discharge
description: Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment
measure: Health Related Quality of Life
time frame: 6 months post-hospital discharge
description: EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.
measure: Health and disability
time frame: 6 months post-hospital discharge
description: WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles
measure: Physical activity
time frame: 6 months post-hospital discharge
description: Wrist worn physical activity monitoring
measure: Nutritional status
time frame: 6 months post-hospital discharge
description: Patient generated subjective global assessment
arm group label: EMDR R-TEP intervention
arm group type: Experimental
description: Participants will receive a minimum of 2 and a maximum of 8 online EMDR R-TEP sessions, starting within 3-months of hospital discharge. Sessions will be delivered online by experienced, suitably trained and registered psychological practitioners.
arm group label: Standard care
arm group type: No Intervention
description: Patients will receive standard post-hospital discharge care.
intervention type: Other
intervention name: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
description: EMDR is a form of psychotherapy treatment whereby the client verbally relates a narrative of a traumatic episode or emotionally disturbing material in brief sequential doses while simultaneously focusing on an external stimulus. The EMDR Recent-Traumatic Events protocol (R-TEP) aims to enable an individual to process memories of the event in order to reduce psychological morbidity. EMDR R-TEP should be delivered within 3-months of the onset of a traumatic event.
arm group label: EMDR R-TEP intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael P Grocott, MD
role: Principal Investigator
affiliation: University Hospital Southampton NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Critical Illness
mesh term: Stress Disorders, Traumatic
mesh term: Anxiety Disorders
mesh term: Stress Disorders, Post-Traumatic
mesh term: Mental Disorders
mesh term: Problem Behavior
sharing ipd: No