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

U

University Hospital Southampton NHS Foundation Trust

Status

Completed

Conditions

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

Treatments

Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT04455360
Protocol version 1.2

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

EMDR R-TEP intervention
Experimental group
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.
Treatment:
Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
Standard care
No Intervention group
Description:
Patients will receive standard post-hospital discharge care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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