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

Primary Purpose

Post Traumatic Stress Disorder, Intensive Care Psychiatric Disorder, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
Sponsored by
University Hospital Southampton NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Traumatic Stress Disorder focused on measuring EMDR, Eye movement desensitisation and reprocessing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EMDR R-TEP intervention

Standard care

Arm 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.

Patients will receive standard post-hospital discharge care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2020
Last Updated
September 28, 2021
Sponsor
University Hospital Southampton NHS Foundation Trust
Collaborators
Dorset HealthCare University NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04455360
Brief Title
Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial
Acronym
Cov-EMERALD
Official Title
EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Southampton NHS Foundation Trust
Collaborators
Dorset HealthCare University NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Intensive Care Psychiatric Disorder, Anxiety Disorders, Depression, Critical Care, COVID
Keywords
EMDR, Eye movement desensitisation and reprocessing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Patient reported outcomes at 6-months post-hospital discharge
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMDR R-TEP intervention
Arm Type
Experimental
Arm 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 Title
Standard care
Arm Type
No Intervention
Arm Description
Patients will receive standard post-hospital discharge care.
Intervention Type
Other
Intervention Name(s)
Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
Intervention 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.
Primary Outcome Measure Information:
Title
Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Post-Traumatic stress disorder
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
Time Frame
6 months post-hospital discharge
Title
Anxiety and depression
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
Time Frame
6 months
Title
Cognitive function
Description
Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment
Time Frame
6 months post-hospital discharge
Title
Health Related Quality of Life
Description
EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.
Time Frame
6 months post-hospital discharge
Title
Health and disability
Description
WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles
Time Frame
6 months post-hospital discharge
Title
Physical activity
Description
Wrist worn physical activity monitoring
Time Frame
6 months post-hospital discharge
Title
Nutritional status
Description
Patient generated subjective global assessment
Time Frame
6 months post-hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Grocott, MD
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
Hamphsire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33203440
Citation
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.
Results Reference
derived

Learn more about this trial

Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial

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