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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|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|
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.
- 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:
- 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
- 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
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
|Contact: Andrew C Bates, BAemail@example.com|
|Contact: Rebecca Cusack, MDfirstname.lastname@example.org|
|University Hospital Southampton NHS Foundation Trust||Recruiting|
|Southampton, Hamphsire, United Kingdom, SO16 6YD|
|Principal Investigator:||Michael P Grocott, MD||University Hospital Southampton NHS Foundation Trust|