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

Depression Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455360
• Other study ID #: Protocol version 1.2
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: September 2021
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• COVID
• Critical Care
• Critical Illness
• Depression
• Disease
• Intensive Care Psychiatric Disorder
• Mental Disorders
• Post Traumatic Stress Disorder
• Problem Behavior
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	Hamphsire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	Dorset HealthCare University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Cognitive function	Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment	6 months post-hospital discharge
Secondary	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
Secondary	Health and disability	WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles	6 months post-hospital discharge
Secondary	Physical activity	Wrist worn physical activity monitoring	6 months post-hospital discharge
Secondary	Nutritional status	Patient generated subjective global assessment	6 months post-hospital discharge