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

EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety Disorders; COVID; Post Traumatic Stress Disorder; Critical Care; Intensive Care Psychiatric Disorder
• Intervention / Treatment: Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol

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: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hamphsire
    • Southampton, Hamphsire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Traumatic stress disorder	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	6 months post-hospital discharge
Anxiety and depression	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	6 months
Cognitive function	Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment	6 months post-hospital discharge
Health Related Quality of Life	EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.	6 months post-hospital discharge
Health and disability	WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles	6 months post-hospital discharge
Physical activity	Wrist worn physical activity monitoring	6 months post-hospital discharge
Nutritional status	Patient generated subjective global assessment	6 months post-hospital discharge

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborators: Dorset HealthCare University NHS Foundation Trust
• Investigators: Principal Investigator: Michael P Grocott, MD, University Hospital Southampton NHS Foundation Trust

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: EMDR; Eye movement desensitisation and reprocessing
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Trauma and Stressor Related Disorders; Disease; Problem Behavior; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorders; Critical Illness
• Other Study ID Numbers: Protocol version 1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No