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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Traumatic Stress Disorder, Intensive Care Psychiatric Disorder, Anxiety Disorders, Depression, Critical Care, COVID

Intervention / Treatment
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* Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMDR R-TEP intervention<br>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<br>* 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.<br>|
| No Intervention: Standard care<br>Patients will receive standard post-hospital discharge care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMDR, Eye movement desensitisation and reprocessing