Clinical trial NCT04455360: Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Intensive Care Psychiatric Disorder
Anxiety Disorders
Depression
Critical Care
COVID
Keywords: EMDR
Eye movement desensitisation and reprocessing
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Dorset HealthCare University NHS Foundation Trust
First posted: 2020-07-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints
timeFrame: 12 months
Secondary outcomes:
measure: Post-Traumatic stress disorder
timeFrame: 6 months post-hospital discharge
measure: Anxiety and depression
timeFrame: 6 months
measure: Cognitive function
timeFrame: 6 months post-hospital discharge
measure: Health Related Quality of Life
timeFrame: 6 months post-hospital discharge
measure: Health and disability
timeFrame: 6 months post-hospital discharge
measure: Physical activity
timeFrame: 6 months post-hospital discharge
measure: Nutritional status
timeFrame: 6 months post-hospital discharge
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hamphsire
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Michael P Grocott, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.