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Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial (Cov-EMERALD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04455360
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Dorset HealthCare University NHS Foundation Trust
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Intensive Care Psychiatric Disorder Anxiety Disorders Depression Critical Care COVID Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Patient reported outcomes at 6-months post-hospital discharge
Primary Purpose: Supportive Care
Official Title: EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: EMDR R-TEP intervention
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.
Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
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.

No Intervention: Standard care
Patients will receive standard post-hospital discharge care.



Primary Outcome Measures :
  1. Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints [ Time Frame: 12 months ]

    Feasibility will be determined by the following measures:

    1. Able to recruit >30% of eligible patients approached
    2. Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention.
    3. Protocol adherence
    4. 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.
    5. Outcome measures completed in 75% or more of trial participants


Secondary Outcome Measures :
  1. Post-Traumatic stress disorder [ Time Frame: 6 months post-hospital discharge ]
    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

  2. Anxiety and depression [ Time Frame: 6 months ]
    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

  3. Cognitive function [ Time Frame: 6 months post-hospital discharge ]
    Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment

  4. Health Related Quality of Life [ Time Frame: 6 months post-hospital discharge ]
    EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.

  5. Health and disability [ Time Frame: 6 months post-hospital discharge ]
    WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles

  6. Physical activity [ Time Frame: 6 months post-hospital discharge ]
    Wrist worn physical activity monitoring

  7. Nutritional status [ Time Frame: 6 months post-hospital discharge ]
    Patient generated subjective global assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute admission to Critical Care who have required mechanical ventilation for at least 24 hours
  • PCR confirmed Covid-19 positive
  • >18 years of age
  • Capacity to provide informed consent

Exclusion Criteria:

  • Acute brain injury
  • Cognitive impairment
  • Pre-existing psychotic diagnosis
  • Not expected to survive post-hospital discharge
  • Refusal to grant consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455360


Contacts
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Contact: Andrew C Bates, BA 02381206317 a.bates@soton.ac.uk
Contact: Rebecca Cusack, MD 02381205308 rebecca.cusack@uhs.nhs.uk

Locations
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United Kingdom
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, Hamphsire, United Kingdom, SO16 6YD
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Dorset HealthCare University NHS Foundation Trust
Investigators
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Principal Investigator: Michael P Grocott, MD University Hospital Southampton NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04455360    
Other Study ID Numbers: Protocol version 1.2
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Southampton NHS Foundation Trust:
EMDR
Eye movement desensitisation and reprocessing
Additional relevant MeSH terms:
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Disease
Critical Illness
Stress Disorders, Traumatic
Anxiety Disorders
Stress Disorders, Post-Traumatic
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms
Trauma and Stressor Related Disorders
Disease Attributes