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

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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

Tracking Information
First Submitted Date  ICMJE June 26, 2020
First Posted Date  ICMJE July 2, 2020
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2020)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
  • 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
  • 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
  • Cognitive function [ Time Frame: 6 months post-hospital discharge ]
    Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment
  • 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.
  • 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
  • Physical activity [ Time Frame: 6 months post-hospital discharge ]
    Wrist worn physical activity monitoring
  • Nutritional status [ Time Frame: 6 months post-hospital discharge ]
    Patient generated subjective global assessment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial
Official Title  ICMJE EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Post Traumatic Stress Disorder
  • Intensive Care Psychiatric Disorder
  • Anxiety Disorders
  • Depression
  • Critical Care
  • COVID
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
  • No Intervention: Standard care
    Patients will receive standard post-hospital discharge care.
Publications * Bates A, Rushbrook S, Shapiro E, Grocott M, Cusack R. CovEMERALD: Assessing the feasibility and preliminary effectiveness of remotely delivered Eye Movement Desensitisation and Reprocessing following Covid-19 related critical illness: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 17;21(1):929. doi: 10.1186/s13063-020-04805-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2020)		 26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrew C Bates, BA 02381206317 a.bates@soton.ac.uk
Contact: Rebecca Cusack, MD 02381205308 rebecca.cusack@uhs.nhs.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04455360
Other Study ID Numbers  ICMJE Protocol version 1.2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital Southampton NHS Foundation Trust
Study Sponsor  ICMJE University Hospital Southampton NHS Foundation Trust
Collaborators  ICMJE Dorset HealthCare University NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: Michael P Grocott, MD University Hospital Southampton NHS Foundation Trust
PRS Account University Hospital Southampton NHS Foundation Trust
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP